Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-29 @ 3:20 PM
Study NCT ID:
NCT00278408
Status:
COMPLETED
Last Update Posted:
2025-08-26
First Post:
2006-01-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rituximab and Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With B-Cell Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D017728', 'term': 'Lymphoma, Large-Cell, Anaplastic'}, {'id': 'D016400', 'term': 'Lymphoma, Large-Cell, Immunoblastic'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dshnhl@uks.eu', 'phone': '+4968411615014', 'title': 'Dr. Viola Poeschel', 'organization': 'Saarland University Medical School'}, 'certainAgreement': {'otherDetails': 'Regarding publications the PIs and the sponsor will be in understanding between considering the publication arrangement of the trial protocol. This only serves the optimization of the research activity and the security of the results for the community.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Each patient will be observed for at least 3 years starting from completion of treatment.', 'description': 'Please note that all patients (pts) had suffered from, at least, one non-SAE. We entered the no. of pts who could have suffered from non-SAEs of CTC-Gr. 3-5 (=no. of pts randomized in each arm), as this was the only part of the non-SAEs, which were statistically analysed. Multiple counts have been possible, as pts could have suffered from more than one non-SAE of CTC-Gr. 3-5.\n\nThe number analyzed differs from overall number analyzed due to missing data.', 'eventGroups': [{'id': 'EG000', 'title': 'Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication', 'description': 'Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 49, 'seriousNumAtRisk': 81, 'deathsNumAffected': 7, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication', 'description': 'Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 58, 'seriousNumAtRisk': 81, 'deathsNumAffected': 7, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': 'Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate', 'otherNumAtRisk': 155, 'deathsNumAtRisk': 155, 'otherNumAffected': 98, 'seriousNumAtRisk': 155, 'deathsNumAffected': 15, 'seriousNumAffected': 43}, {'id': 'EG003', 'title': 'Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 82, 'seriousNumAtRisk': 150, 'deathsNumAffected': 11, 'seriousNumAffected': 41}, {'id': 'EG004', 'title': 'Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication', 'description': 'Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 41, 'seriousNumAtRisk': 114, 'deathsNumAffected': 10, 'seriousNumAffected': 30}, {'id': 'EG005', 'title': 'Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication', 'description': 'Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 65, 'seriousNumAtRisk': 114, 'deathsNumAffected': 11, 'seriousNumAffected': 27}], 'otherEvents': [{'term': 'Nausea CTC 3-5', 'notes': 'due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 148, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 138, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 112, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting CTC 3-5', 'notes': 'due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 148, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoe CTC 3-5', 'notes': 'due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia CTC 3-5', 'notes': 'due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac functions CTC 3-5', 'notes': 'due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 138, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sensory CTC 3-5', 'notes': 'due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 150, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 141, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 103, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection CTC 3-5', 'notes': 'due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 144, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 105, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 113, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation CTC 3-5', 'notes': 'due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 112, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucositis CTC 3-5', 'notes': 'due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 112, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mood CTC 3-5', 'notes': 'due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 112, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergy CTC 3-5', 'notes': 'due to limited documentation (missing data) in the database the number of paticipants at risk for each adverse event is less than the total number of participants at risk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 139, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukocytopenia CTC 3, 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 76, 'numAffected': 45}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 36}, {'groupId': 'EG004', 'numAtRisk': 49, 'numAffected': 21}, {'groupId': 'EG005', 'numAtRisk': 55, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia CTC 3, 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 142, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 99, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia CTC 3, 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 136, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 104, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Life-threatening infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 150, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 114, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'secondary neoplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 150, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 114, 'numAffected': 8}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'unplanned hospitalisation (emergency case)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 36, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 150, 'numEvents': 37, 'numAffected': 27}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 114, 'numEvents': 25, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 150, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 114, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 114, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '3 Years Event-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '114', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication', 'description': 'Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG001', 'title': 'Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication', 'description': 'Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG002', 'title': 'Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG003', 'title': 'Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG004', 'title': 'Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication', 'description': 'Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG005', 'title': 'Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication', 'description': 'Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '123', 'groupId': 'OG003'}, {'value': '89', 'groupId': 'OG004'}, {'value': '92', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.', 'description': 'Event-free survival was the primary endpoint, which was defined as the time from randomization until one of the following events had occurred: progression during therapy, partial response, no change, unknown status at the end of study therapy, relapse after complete response or unconfirmed complete response, death from any cause; or additional treatment, whichever came first.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '3 Years Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '114', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication', 'description': 'Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG001', 'title': 'Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication', 'description': 'Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG002', 'title': 'Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG003', 'title': 'Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG004', 'title': 'Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication', 'description': 'Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG005', 'title': 'Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication', 'description': 'Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}, {'value': '96', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.', 'description': 'Progression of disease is defined as: recurrence of disease symptoms, development of new lymphatic or extralymphatic lesions or marked increase in lymphoma manifestation size by more than 25% in comparison with baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '3 Years Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '114', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication', 'description': 'Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG001', 'title': 'Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication', 'description': 'Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG002', 'title': 'Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG003', 'title': 'Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG004', 'title': 'Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication', 'description': 'Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG005', 'title': 'Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication', 'description': 'Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}, {'value': '107', 'groupId': 'OG004'}, {'value': '108', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.', 'description': 'Overall survival was defined as the time from randomization to death of any cause.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Complete Remissions and Progressive Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '114', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication', 'description': 'Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG001', 'title': 'Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication', 'description': 'Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG002', 'title': 'Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG003', 'title': 'Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG004', 'title': 'Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication', 'description': 'Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG005', 'title': 'Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication', 'description': 'Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}], 'classes': [{'title': 'Rate of complete remissions', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '133', 'groupId': 'OG003'}, {'value': '109', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}]}]}, {'title': 'Rate of progressive disease', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With a Relapse After a CR/CRu', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}, {'value': '133', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}, {'value': '105', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication', 'description': 'Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG001', 'title': 'Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication', 'description': 'Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG002', 'title': 'Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG003', 'title': 'Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG004', 'title': 'Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication', 'description': 'Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG005', 'title': 'Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication', 'description': 'Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.', 'description': 'Relapse is defined as, recurrence of disease symptoms, development of new lymphatic or extralymphatic lesions or a marked increase in lymphoma manifestation size by more thyn 25% after at least 2 months CR or CRu from the time point of the final restaging examination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients who reached a CR/CRu after at least 2 months after the final restaging examination were taken for the relapse analysis.'}, {'type': 'SECONDARY', 'title': 'Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '114', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication', 'description': 'Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG001', 'title': 'Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication', 'description': 'Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG002', 'title': 'Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG003', 'title': 'Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG004', 'title': 'Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication', 'description': 'Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG005', 'title': 'Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication', 'description': 'Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}], 'classes': [{'title': 'rate of secondary neoplasm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '114', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}, {'title': 'Leukocytopenia CTC 3 - 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}]}, {'title': 'Thrombocytopenia CTC 3 - 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}, {'value': '137', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}, {'value': '103', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Anemia CTC 3 - 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}]}, {'title': 'Nausea CTC 3 - 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '112', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Vomiting CTC 3 - 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '137', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '112', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Diarrhoe CTC 3 - 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '112', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Constipation CTC 3 - 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '112', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Mucositis CTC 3 - 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '140', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '112', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Arrhythmia CTC 3 - 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '112', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Cardiac functions CTC 3 - 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '112', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Sensory CTC 3 - 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}, {'value': '103', 'groupId': 'OG004'}, {'value': '111', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}, {'title': 'Mood CTC 3 - 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '112', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Allergy CTC 3 - 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '113', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Infection CTC 3 - 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '144', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '113', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed differs from overall number analyzed due to missing data.'}, {'type': 'SECONDARY', 'title': 'Adherence to Protocol - Absolute Dose Vincristine and Prednisone in mg (Median)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '114', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication', 'description': 'Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG001', 'title': 'Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication', 'description': 'Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG002', 'title': 'Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG003', 'title': 'Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG004', 'title': 'Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication', 'description': 'Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG005', 'title': 'Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication', 'description': 'Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}], 'classes': [{'title': 'Absolute dose vincristine', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '13'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '12'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '13'}, {'value': '12', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '12'}, {'value': '12', 'groupId': 'OG004', 'lowerLimit': '2', 'upperLimit': '12'}, {'value': '12', 'groupId': 'OG005', 'lowerLimit': '2', 'upperLimit': '12'}]}]}, {'title': 'Absolute dose prednisone', 'categories': [{'measurements': [{'value': '3000', 'groupId': 'OG000', 'lowerLimit': '500', 'upperLimit': '5750'}, {'value': '3000', 'groupId': 'OG001', 'lowerLimit': '400', 'upperLimit': '3750'}, {'value': '3000', 'groupId': 'OG002', 'lowerLimit': '500', 'upperLimit': '3900'}, {'value': '3000', 'groupId': 'OG003', 'lowerLimit': '1000', 'upperLimit': '3900'}, {'value': '3000', 'groupId': 'OG004', 'lowerLimit': '1000', 'upperLimit': '6000'}, {'value': '3000', 'groupId': 'OG005', 'lowerLimit': '500', 'upperLimit': '4000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.', 'unitOfMeasure': 'mg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Health-economic Aspects - Number of Patients Who Received Antibiotic Intervention and/or Red Blood Cell and Platelet Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '114', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication', 'description': 'Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG001', 'title': 'Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication', 'description': 'Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG002', 'title': 'Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG003', 'title': 'Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG004', 'title': 'Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication', 'description': 'Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG005', 'title': 'Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication', 'description': 'Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}], 'classes': [{'title': 'antibiotics interventional per patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}, {'value': '147', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '113', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}]}, {'title': 'red blood cell and platelet transfusions per patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}, {'value': '147', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '113', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed differs from overall number analyzed due to missing data.'}, {'type': 'SECONDARY', 'title': 'Adherence to Protocol - Total Duration of Chemotherapy in Days (Median)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '114', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication', 'description': 'Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG001', 'title': 'Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication', 'description': 'Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG002', 'title': 'Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG003', 'title': 'Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG004', 'title': 'Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication', 'description': 'Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG005', 'title': 'Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication', 'description': 'Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '126'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '69', 'upperLimit': '99'}, {'value': '105', 'groupId': 'OG002', 'lowerLimit': '102', 'upperLimit': '124'}, {'value': '71', 'groupId': 'OG003', 'lowerLimit': '14', 'upperLimit': '111'}, {'value': '105', 'groupId': 'OG004', 'lowerLimit': '21', 'upperLimit': '137'}, {'value': '70', 'groupId': 'OG005', 'lowerLimit': '14', 'upperLimit': '112'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adherence to Protocol - Absolute Dose Cyclophosphamide, Doxorubicin and Rituximab in mg/m² (Median)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '114', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication', 'description': 'Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG001', 'title': 'Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication', 'description': 'Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG002', 'title': 'Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG003', 'title': 'Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'OG004', 'title': 'Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication', 'description': 'Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'OG005', 'title': 'Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication', 'description': 'Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}], 'classes': [{'title': 'Cyclophosphamide', 'categories': [{'measurements': [{'value': '4474', 'groupId': 'OG000', 'lowerLimit': '750', 'upperLimit': '4693'}, {'value': '4482', 'groupId': 'OG001', 'lowerLimit': '738', 'upperLimit': '4875'}, {'value': '4464', 'groupId': 'OG002', 'lowerLimit': '762', 'upperLimit': '4750'}, {'value': '4474', 'groupId': 'OG003', 'lowerLimit': '1480', 'upperLimit': '4667'}, {'value': '4476', 'groupId': 'OG004', 'lowerLimit': '1364', 'upperLimit': '4737'}, {'value': '4455', 'groupId': 'OG005', 'lowerLimit': '742', 'upperLimit': '4714'}]}]}, {'title': 'Doxorubicin', 'categories': [{'measurements': [{'value': '300', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '316'}, {'value': '300', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '323'}, {'value': '299', 'groupId': 'OG002', 'lowerLimit': '48', 'upperLimit': '316'}, {'value': '298', 'groupId': 'OG003', 'lowerLimit': '90', 'upperLimit': '314'}, {'value': '298', 'groupId': 'OG004', 'lowerLimit': '91', 'upperLimit': '318'}, {'value': '298', 'groupId': 'OG005', 'lowerLimit': '50', 'upperLimit': '314'}]}]}, {'title': 'Rituximab', 'categories': [{'measurements': [{'value': '2244', 'groupId': 'OG000', 'lowerLimit': '350', 'upperLimit': '2438'}, {'value': '2232', 'groupId': 'OG001', 'lowerLimit': '375', 'upperLimit': '2413'}, {'value': '2238', 'groupId': 'OG002', 'lowerLimit': '371', 'upperLimit': '2500'}, {'value': '2245', 'groupId': 'OG003', 'lowerLimit': '740', 'upperLimit': '2402'}, {'value': '2242', 'groupId': 'OG004', 'lowerLimit': '682', 'upperLimit': '2520'}, {'value': '2228', 'groupId': 'OG005', 'lowerLimit': '389', 'upperLimit': '2471'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.', 'unitOfMeasure': 'mg/m²', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication', 'description': 'Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'FG001', 'title': 'Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication', 'description': 'Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'FG002', 'title': 'Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'FG003', 'title': 'Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'FG004', 'title': 'Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication', 'description': 'Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'FG005', 'title': 'Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication', 'description': 'Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '81'}, {'groupId': 'FG002', 'numSubjects': '155'}, {'groupId': 'FG003', 'numSubjects': '150'}, {'groupId': 'FG004', 'numSubjects': '114'}, {'groupId': 'FG005', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '133'}, {'groupId': 'FG003', 'numSubjects': '135'}, {'groupId': 'FG004', 'numSubjects': '110'}, {'groupId': 'FG005', 'numSubjects': '109'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'From 02nd January 2006, to 16th November 2015, 700 patients were enrolled at 148 sites including hospitals and private practitioners.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}, {'value': '695', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication', 'description': 'Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'BG001', 'title': 'Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication', 'description': 'Arm II (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'BG002', 'title': 'Interventional: 6 R-CHOP-21 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm III (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'BG003', 'title': 'Interventional: 6 R-CHOP-14 + Radiotherapy for Patients With Radiotherapy Indication', 'description': 'Arm IV (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity followed by consolidating radiotherapy with 39.6 Gy.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'BG004', 'title': 'Interventional: 6 R-CHOP-21 for Patients Without Radiotherapy Indication', 'description': 'Arm V (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate'}, {'id': 'BG005', 'title': 'Interventional: 6 R-CHOP-14 for Patients Without Radiotherapy Indication', 'description': 'Arm VI (R-CHOP-14): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nrituximab\n\ncyclophosphamide\n\ndoxorubicin hydrochloride\n\nprednisone\n\nvincristine sulfate\n\nfilgrastim'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}, {'value': '695', 'groupId': 'BG006'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}, {'value': '695', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}, {'value': '695', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '60'}, {'value': '45', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '60'}, {'value': '46', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '60'}, {'value': '44', 'groupId': 'BG003', 'lowerLimit': '18', 'upperLimit': '60'}, {'value': '50', 'groupId': 'BG004', 'lowerLimit': '18', 'upperLimit': '60'}, {'value': '49', 'groupId': 'BG005', 'lowerLimit': '20', 'upperLimit': '60'}, {'value': '47', 'groupId': 'BG006', 'lowerLimit': '18', 'upperLimit': '60'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}, {'value': '114', 'groupId': 'BG005'}, {'value': '695', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '43', 'groupId': 'BG005'}, {'value': '292', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}, {'value': '71', 'groupId': 'BG005'}, {'value': '403', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': '700 patients were randomized, however 695 were analyzed due to a withdrawal of consent (5 patients)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-02-25', 'size': 28762514, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-04-02T03:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2006-01-16', 'resultsFirstSubmitDate': '2021-07-02', 'studyFirstSubmitQcDate': '2006-01-16', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-07', 'studyFirstPostDateStruct': {'date': '2006-01-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3 Years Event-free Survival', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.', 'description': 'Event-free survival was the primary endpoint, which was defined as the time from randomization until one of the following events had occurred: progression during therapy, partial response, no change, unknown status at the end of study therapy, relapse after complete response or unconfirmed complete response, death from any cause; or additional treatment, whichever came first.'}], 'secondaryOutcomes': [{'measure': '3 Years Progression-free Survival', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.', 'description': 'Progression of disease is defined as: recurrence of disease symptoms, development of new lymphatic or extralymphatic lesions or marked increase in lymphoma manifestation size by more than 25% in comparison with baseline.'}, {'measure': '3 Years Overall Survival', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.', 'description': 'Overall survival was defined as the time from randomization to death of any cause.'}, {'measure': 'Rate of Complete Remissions and Progressive Disease', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.'}, {'measure': 'Number of Patients With a Relapse After a CR/CRu', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.', 'description': 'Relapse is defined as, recurrence of disease symptoms, development of new lymphatic or extralymphatic lesions or a marked increase in lymphoma manifestation size by more thyn 25% after at least 2 months CR or CRu from the time point of the final restaging examination'}, {'measure': 'Safety (Adverse Events, Serious Adverse Events, Rate of Secondary Neoplasia, Selected Laboratory Parameters, Including Leucocytes, Thrombocytes, and Haemoglobin)', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.'}, {'measure': 'Adherence to Protocol - Absolute Dose Vincristine and Prednisone in mg (Median)', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.'}, {'measure': 'Health-economic Aspects - Number of Patients Who Received Antibiotic Intervention and/or Red Blood Cell and Platelet Transfusion', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.'}, {'measure': 'Adherence to Protocol - Total Duration of Chemotherapy in Days (Median)', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.'}, {'measure': 'Adherence to Protocol - Absolute Dose Cyclophosphamide, Doxorubicin and Rituximab in mg/m² (Median)', 'timeFrame': 'Each patient will be observed for 3 years starting from completion of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['contiguous stage II grade 3 follicular lymphoma', 'noncontiguous stage II grade 3 follicular lymphoma', 'stage I grade 3 follicular lymphoma', 'stage III grade 3 follicular lymphoma', 'stage IV grade 3 follicular lymphoma', 'contiguous stage II adult diffuse large cell lymphoma', 'contiguous stage II adult diffuse mixed cell lymphoma', 'noncontiguous stage II adult diffuse large cell lymphoma', 'noncontiguous stage II adult diffuse mixed cell lymphoma', 'stage I adult diffuse large cell lymphoma', 'stage I adult diffuse mixed cell lymphoma', 'stage III adult diffuse large cell lymphoma', 'stage III adult diffuse mixed cell lymphoma', 'stage IV adult diffuse large cell lymphoma', 'stage IV adult diffuse mixed cell lymphoma', 'nodal marginal zone B-cell lymphoma', 'anaplastic large cell lymphoma', 'contiguous stage II adult immunoblastic large cell lymphoma', 'noncontiguous stage II adult immunoblastic large cell lymphoma', 'stage I adult immunoblastic large cell lymphoma', 'stage III adult immunoblastic large cell lymphoma', 'stage IV adult immunoblastic large cell lymphoma', 'contiguous stage II adult Burkitt lymphoma', 'contiguous stage II mantle cell lymphoma', 'noncontiguous stage II adult Burkitt lymphoma', 'noncontiguous stage II mantle cell lymphoma', 'stage I adult Burkitt lymphoma', 'stage I mantle cell lymphoma', 'stage III adult Burkitt lymphoma', 'stage III mantle cell lymphoma', 'stage IV adult Burkitt lymphoma', 'stage IV mantle cell lymphoma', 'contiguous stage II marginal zone lymphoma', 'noncontiguous stage II marginal zone lymphoma', 'stage I marginal zone lymphoma', 'stage III marginal zone lymphoma', 'stage IV marginal zone lymphoma'], 'conditions': ['Lymphoma']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Radiotherapy (RT) to bulky (B) and extralymphatic (E) disease in combination with 6xR-CHOP-14 or R-CHOP-21 in young good-prognosis DLBCL patients: Results of the 2x2 randomized UNFOLDER trial of the DSHNHL/GLA. Michael Pfreundschuh, Niels Murawski, Marita Ziepert, Bettina Altmann, Martin H. Dreyling, Peter Borchmann, Stefano Luminari, Mathias Witzens-Harig, Judith Dierlamm, Mathias Haenel, Lorenz Truemper, Bernd Metzner, Eva Lengfelder, Ulrich B. Keller, Christian Ruebe, Christian Berdel, Norbert Schmitz, Gerhard Held, and Viola Poeschel Journal of Clinical Oncology 2018 36:15_suppl, 7574-7574'}, {'type': 'RESULT', 'citation': 'Role of radiotherapy and dose-densification of R-CHOP in primary mediastinal B-cell lymphoma: A subgroup analysis of the unfolder trial of the German Lymphoma Alliance (GLA). Gerhard Held, Lorenz Thurner, Viola Poeschel, Christian Berdel, German Ott, Christian Schmidt, Andreas Viardot, Peter Borchmann, Ofer Shpilberg, Maike Nickelsen, Massimo Federico, Peter de Nully Brown, Niels Murawski, Lorenz H. Trumper, Heinz Schmidberger, Christian Ruebe, Jochen Fleckenstein, Norbert Schmitz, Markus Loeffler, Marita Ziepert, and German Lymphoma Alliance Journal of Clinical Oncology 2020 38:15_suppl, 8041-8041'}, {'pmid': '37427146', 'type': 'DERIVED', 'citation': 'Thurner L, Ziepert M, Berdel C, Schmidt C, Borchmann P, Kaddu-Mulindwa D, Viardot A, Witzens-Harig M, Dierlamm J, Haenel M, Metzner B, Wulf G, Lengfelder E, Keller UB, Frickhofen N, Nickelsen M, Gaska T, Griesinger F, Mahlberg R, Marks R, Shpilberg O, Lindemann HW, Soekler M, Fischer von Weikersthal L, Kiehl M, Roemer E, Bentz M, Krammer-Steiner B, Trappe R, de Nully Brown P, Federico M, Merli F, Engelhard M, Glass B, Schmitz N, Truemper L, Bewarder M, Hartmann F, Murawski N, Stilgenbauer S, Rosenwald A, Altmann B, Schmidberger H, Fleckenstein J, Loeffler M, Poeschel V, Held G. Radiation and Dose-densification of R-CHOP in Aggressive B-cell Lymphoma With Intermediate Prognosis: The UNFOLDER Study. Hemasphere. 2023 Jul 5;7(7):e904. doi: 10.1097/HS9.0000000000000904. eCollection 2023 Jul.'}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving rituximab and combination chemotherapy together with radiation therapy may kill more cancer cells. It is not yet known which schedule of rituximab and combination chemotherapy is more effective when given with or without radiation therapy in treating non-Hodgkin's lymphoma.\n\nPURPOSE: This randomized phase III trial is studying two different schedules of rituximab and combination chemotherapy with or without radiation therapy to compare how well they work in treating patients with aggressive B-cell non-Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\nPrimary\n\n* Compare the time to treatment failure in patients with previously untreated, low-risk, aggressive, B-cell non-Hodgkin's lymphoma treated with 2 different schedules of immunochemotherapy comprising rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone with vs without radiotherapy.\n\nSecondary\n\n* Compare the time to progression in patients treated with these regimens.\n* Compare the overall and disease-free/relapse-free survival of patients treated with these regimens.\n* Compare the complete response rate in patients treated with these regimens.\n* Compare the tumor control in patients treated with these regimens.\n* Compare the safety of these regimens in these patients.\n* Compare the pharmacoeconomics of these regimens.\n* Compare patient adherence to these regimens.\n\nOUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to study center, serum lactic dehydrogenase level (≤ upper limit of normal \\[ULN\\] vs \\> ULN), disease stage (I or II vs III or IV), ECOG performance status (0-1 vs 2-3), bulky disease, and extranodal involvement. Patients with initial bulky disease and/or qualifying extranodal involvement are randomized to 1 of 4 treatment arms. Patients with non-bulky disease are randomized to treatment arms I or III.\n\nAll patients will be given the option of receiving a 1-week course of pretreatment therapy comprising vincristine IV once on day -6 and oral prednisone once daily on days -6 to 0.\n\n* Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n* Arm II (R-CHOP-21 and radiotherapy): Patients receive R-CHOP as in arm I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after the last course of R-CHOP, patients who achieve a complete remission (CR) undergo radiotherapy 5 days a week for approximately 5½ weeks.\n* Arm III (R-CHOP-14): Patients receive R-CHOP as in arm I. Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 4-13 or until blood counts recover. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n* Arm IV (R-CHOP-14 and radiotherapy): Patients receive R-CHOP as in arm I. Patients also receive G-CSF an in arm III. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after the last course of R-CHOP, patients who achieve CR undergo radiotherapy as in arm II.\n\nPatients in all arms undergo restaging of their disease after courses 3 and 6 of R-CHOP. Patients with stable disease after 6 courses or disease progression after courses 3 or 6 proceed to salvage chemotherapy off study. Patients achieving a partial remission or an unconfirmed CR after 6 courses undergo additional restaging 4 weeks later. Patients with disease progression proceed to salvage chemotherapy off study. Patients who achieve CR after 6 courses of R-CHOP or have a confirmed CR after the additional restaging undergo radiotherapy according to randomization (as above).\n\nAfter completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 1,072 patients will be accrued for this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma, including the following subtypes:\n\n * Grade 3 follicular lymphoma\n * Diffuse B-cell lymphoma, including diffuse large cell lymphoma with the following variants:\n\n * Centroblastic\n * Immunoblastic\n * Plasmablastic\n * Anaplastic large cell\n * T-cell-rich B-cell lymphoma\n * Primary effusion lymphoma\n * Intravascular B-cell lymphoma\n * Primary mediastinal B-cell lymphoma\n * Burkitt's or Burkitt-like lymphoma\n * Mantle cell lymphoma (blastoid)\n * Aggressive marginal zone lymphoma (monocytoid)\n* Previously untreated disease\n* CD20-positive disease\n* International prognostic index (IPI) score 0 or 1 (age-adjusted)\n\n * Only patients with bulky disease, as defined by largest single or conglomerate tumor ≥ 7.5 cm in diameter, are allowed to have an IPI score of 0\n* No mucosa-associated lymphoid tissue (MALT) lymphoma\n* No CNS involvement of lymphoma (intracerebral, meningeal, or intraspinal)\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Platelet count ≥ 100,000/mm³\n* WBC ≥ 2,500/mm³\n* No known hypersensitivity to the study medications\n* No known HIV-positivity\n* No active hepatitis infection\n* Not pregnant or lactating\n* Negative pregnancy test\n* No other malignancy within the past 5 years except carcinoma in situ or basal cell skin cancer\n* No impaired left ventricular function\n* No severe cardiac arrhythmias\n* No other impaired organ function\n* No other serious disorder\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy or radiotherapy\n* No prior immunosuppressive treatment with cytostatics\n* No concurrent participation in other treatment studies"}, 'identificationModule': {'nctId': 'NCT00278408', 'briefTitle': "Rituximab and Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With B-Cell Non-Hodgkin's Lymphoma", 'organization': {'class': 'OTHER', 'fullName': 'Universität des Saarlandes'}, 'officialTitle': 'Randomized Study Comparing an Immuno-Chemotherapy With 6 Cycles of the Monoclonal Anti-CD20 Antibody Rituximab in Combination With 6 Cycles of Chemotherapy With CHOP ( Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) at 21-day Intervals or 14-day Intervals, Both With or Without Consolidating Radiotherapy or Large Tumour Masses (≥7.5 cm) and/or Extranodal Involvement in Patients With Aggressive CD20 B-Cell Lymphoma Aged 18 to 60 Years With Age-Adjusted IPI=1 (All) or IPI=0 With a Large Tumour Mass (≥7.5 cm) [UNFOLDER 21/14 Study]', 'orgStudyIdInfo': {'id': 'CDR0000459796'}, 'secondaryIdInfos': [{'id': 'DSHNHL-2004-3'}, {'id': 'EUDRACT-2005-005218-19'}, {'id': 'EU-205111'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Interventional: 6 R-CHOP-21', 'description': 'Arm I (R-CHOP-21): Patients receive R-CHOP immunochemotherapy comprising rituximab IV, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Biological: rituximab', 'Drug: cyclophosphamide', 'Drug: doxorubicin hydrochloride', 'Drug: prednisone', 'Drug: vincristine sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interventional: 6 R-CHOP-21 + radiotherapy', 'description': 'Arm II (R-CHOP-21 and radiotherapy): Patients receive R-CHOP as in arm I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after the last course of R-CHOP, patients who achieve a complete remission (CR) undergo radiotherapy 5 days a week for approximately 5½ weeks.', 'interventionNames': ['Biological: rituximab', 'Drug: cyclophosphamide', 'Drug: doxorubicin hydrochloride', 'Drug: prednisone', 'Drug: vincristine sulfate', 'Radiation: radiation therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interventional: 6 R-CHOP-14', 'description': 'Arm III (R-CHOP-14): Patients receive R-CHOP as in arm I. Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 4-13 or until blood counts recover. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Biological: filgrastim', 'Biological: rituximab', 'Drug: cyclophosphamide', 'Drug: doxorubicin hydrochloride', 'Drug: prednisone', 'Drug: vincristine sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interventional: 6 R-CHOP-14 and radiotherapy', 'description': 'Arm IV (R-CHOP-14 and radiotherapy): Patients receive R-CHOP as in arm I. Patients also receive G-CSF an in arm III. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after the last course of R-CHOP, patients who achieve CR undergo radiotherapy as in arm II.', 'interventionNames': ['Biological: filgrastim', 'Biological: rituximab', 'Drug: cyclophosphamide', 'Drug: doxorubicin hydrochloride', 'Drug: prednisone', 'Drug: vincristine sulfate', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'filgrastim', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Interventional: 6 R-CHOP-14', 'Interventional: 6 R-CHOP-14 and radiotherapy']}, {'name': 'rituximab', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Interventional: 6 R-CHOP-14', 'Interventional: 6 R-CHOP-14 and radiotherapy', 'Interventional: 6 R-CHOP-21', 'Interventional: 6 R-CHOP-21 + radiotherapy']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'armGroupLabels': ['Interventional: 6 R-CHOP-14', 'Interventional: 6 R-CHOP-14 and radiotherapy', 'Interventional: 6 R-CHOP-21', 'Interventional: 6 R-CHOP-21 + radiotherapy']}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['Interventional: 6 R-CHOP-14', 'Interventional: 6 R-CHOP-14 and radiotherapy', 'Interventional: 6 R-CHOP-21', 'Interventional: 6 R-CHOP-21 + radiotherapy']}, {'name': 'prednisone', 'type': 'DRUG', 'armGroupLabels': ['Interventional: 6 R-CHOP-14', 'Interventional: 6 R-CHOP-14 and radiotherapy', 'Interventional: 6 R-CHOP-21', 'Interventional: 6 R-CHOP-21 + radiotherapy']}, {'name': 'vincristine sulfate', 'type': 'DRUG', 'armGroupLabels': ['Interventional: 6 R-CHOP-14', 'Interventional: 6 R-CHOP-14 and radiotherapy', 'Interventional: 6 R-CHOP-21', 'Interventional: 6 R-CHOP-21 + radiotherapy']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'armGroupLabels': ['Interventional: 6 R-CHOP-14 and radiotherapy', 'Interventional: 6 R-CHOP-21 + radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet, Department of Hematology', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Herlev', 'country': 'Denmark', 'facility': 'Amtssygehuset i Herlev', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'city': 'Aachen', 'country': 'Germany', 'facility': 'GMP Tummes/Weinberg', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': 'D-92224', 'city': 'Amberg', 'country': 'Germany', 'facility': 'Klinikum St. Marien', 'geoPoint': {'lat': 49.44287, 'lon': 11.86267}}, {'zip': 'DOH-86156', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Klinikum Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '26603', 'city': 'Aurich', 'country': 'Germany', 'facility': 'Kreiskrankenhaus Aurich', 'geoPoint': {'lat': 53.46963, 'lon': 7.48239}}, {'zip': 'D-95445', 'city': 'Bayreuth', 'country': 'Germany', 'facility': 'Klinikum Bayreuth', 'geoPoint': {'lat': 49.94782, 'lon': 11.57893}}, {'zip': 'D-10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite - 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