Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-28 @ 8:47 PM
Study NCT ID:
NCT00053768
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2003-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy Followed By Radiation Therapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D016400', 'term': 'Lymphoma, Large-Cell, Immunoblastic'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-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': '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'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'C079446', 'term': 'EPOCH protocol'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'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': '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': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 392}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2006-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-14', 'studyFirstSubmitDate': '2003-02-05', 'studyFirstSubmitQcDate': '2003-02-05', 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to treatment failure (TTF) at first relapse', 'timeFrame': '3 years within study and periodically after study completion', 'description': 'Time to Treatment failure using the Kaplan\\_Meier-Method'}], 'secondaryOutcomes': [{'measure': 'Complete response rate at first relapse', 'timeFrame': '3 years within study and periodically after study completion', 'description': 'Number of complete remission (CR) and unconfirmed complete Remission (CRu)'}, {'measure': 'Survival time', 'timeFrame': '3 years within study and periodically after study completion', 'description': 'Time till death (whatever cause)'}, {'measure': 'Tumor control', 'timeFrame': 'thought the treatment', 'description': 'Calcution of treatment Duration using the Kaplan-Meier method'}, {'measure': 'Disease-free survival', 'timeFrame': '3 years within study and periodically after study completion', 'description': 'Time of disease-free survivial'}]}, '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 mixed cell lymphoma', 'noncontiguous stage II adult diffuse mixed cell lymphoma', 'stage I adult diffuse mixed cell lymphoma', 'stage III adult diffuse mixed cell lymphoma', 'stage IV adult diffuse mixed cell lymphoma', 'contiguous stage II adult diffuse large cell lymphoma', 'contiguous stage II adult Burkitt lymphoma', 'noncontiguous stage II adult diffuse large cell lymphoma', 'noncontiguous stage II adult Burkitt lymphoma', 'stage I adult diffuse large cell lymphoma', 'stage I adult Burkitt lymphoma', 'stage III adult diffuse large cell lymphoma', 'stage III adult Burkitt lymphoma', 'stage IV adult diffuse large cell lymphoma', 'stage IV adult Burkitt 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 lymphoblastic lymphoma', 'noncontiguous stage II adult lymphoblastic lymphoma', 'stage I adult lymphoblastic lymphoma', 'stage III adult lymphoblastic lymphoma', 'stage IV adult lymphoblastic lymphoma', 'contiguous stage II mantle cell lymphoma', 'noncontiguous stage II mantle cell lymphoma', 'stage I mantle cell lymphoma', 'stage III mantle cell lymphoma', 'stage IV mantle cell lymphoma'], 'conditions': ['Lymphoma']}, 'referencesModule': {'references': [{'pmid': '18212092', 'type': 'BACKGROUND', 'citation': "Trumper L, Zwick C, Ziepert M, Hohloch K, Schmits R, Mohren M, Liersch R, Bentz M, Graeven U, Wruck U, Hoffmann M, Metzner B, Hasenclever D, Loeffler M, Pfreundschuh M; German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL). Dose-escalated CHOEP for the treatment of young patients with aggressive non-Hodgkin's lymphoma: I. A randomized dose escalation and feasibility study with bi- and tri-weekly regimens. Ann Oncol. 2008 Mar;19(3):538-44. doi: 10.1093/annonc/mdm497. Epub 2008 Jan 22."}, {'pmid': '18065407', 'type': 'RESULT', 'citation': "Pfreundschuh M, Zwick C, Zeynalova S, Duhrsen U, Pfluger KH, Vrieling T, Mesters R, Mergenthaler HG, Einsele H, Bentz M, Lengfelder E, Trumper L, Rube C, Schmitz N, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL). Dose-escalated CHOEP for the treatment of young patients with aggressive non-Hodgkin's lymphoma: II. Results of the randomized high-CHOEP trial of the German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL). Ann Oncol. 2008 Mar;19(3):545-52. doi: 10.1093/annonc/mdm514. Epub 2007 Dec 6."}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different ways may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known which combination chemotherapy regimen followed by radiation therapy is more effective in treating aggressive non-Hodgkin's lymphoma.\n\nPURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens followed by radiation therapy to compare how well they work in treating patients with aggressive non-Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\n* Compare the efficacy of standard-dose vs high-dose cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone followed by radiotherapy, in terms of time to treatment failure, in patients with aggressive non-Hodgkin's lymphoma.\n* Compare the acute and long-term toxic effects of these regimens in these patients.\n* Compare the complete response rate, survival and tumor control, and disease-free survival in patients treated with these regimens.\n* Analyze the time to relapse after radiotherapy in these patients.\n\nOUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to LDH levels (no greater than upper limit of normal \\[ULN\\] vs greater than ULN), initial bulky disease (yes vs no), stage (I or II vs II or IV), ECOG performance status (0 or 1 vs 2 or 3), and participating center. Patients are randomized to 1 of 2 treatment arms as follows:\n\n* Arm I (Standard dose): Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; etoposide IV on days 1-3; and oral prednisone on days 1-5 (CHOEP) in standard doses.\n* Arm II (Escalated dose): Patients receive high-dose CHOEP as in arm I. Patients also receive filgrastim (G-CSF) subcutaneously on days 6-12.\n\nIn both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of CHOEP chemotherapy, patients with initial bulky disease or extranodal involvement undergo radiotherapy 5 days a week for 4 weeks.\n\nPatients who undergo radiotherapy are followed at 2 months after radiotherapy. All patients (including those who undergo radiotherapy) are followed every 3 months for 2 years and then every 6 months for 3 years.\n\nPROJECTED ACCRUAL: A total of 389 patients were 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 non-Hodgkin's lymphoma\n\n * Previously untreated disease\n* Favorable prognosis\n\n * International Prognostic Index score of 0-1\n* No more than 25% marrow involvement\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 to 60\n\nPerformance status\n\n* ECOG 0-3 OR\n* Karnofsky 40-100%\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Platelet count at least 100,000/mm\\^3\n* WBC at least 2,500/mm\\^3\n\nHepatic\n\n* No active hepatitis infection\n\nRenal\n\n* Not specified\n\nOther\n\n* HIV negative\n* Not pregnant or nursing\n* No relevant accompanying disease\n* No other concurrent malignancy\n* No contraindications to any study medications\n* No prior noncompliance by patient\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No prior radiotherapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* No other concurrent participation in another treatment study"}, 'identificationModule': {'nctId': 'NCT00053768', 'briefTitle': "Combination Chemotherapy Followed By Radiation Therapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma", 'organization': {'class': 'OTHER', 'fullName': 'Universität des Saarlandes'}, 'officialTitle': 'Randomised Trial Comparing Chemotherapy Mit CHOEP (Cyclophosphamid, Doxorubicin, Vincristin, Etoposid Und Prednison) In 21-Day Intervals In Standard And Escalated Doses In Patients Aged 18-60 Years Of Age With Aggresive Non-Hodgkin-Lymphomas Favourable Prognoses', 'orgStudyIdInfo': {'id': 'CDR0000269371'}, 'secondaryIdInfos': [{'id': 'DSHNHL-1999-2'}, {'id': 'EU-20242'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CHOEP-21', 'description': 'CHOEP-21-Schema:\n\nCyclophosphamid (750 mg/m2 i.v. d1), Doxorubicin (50 mg/m2 i.v. d1), Vincristin (2 mg i.v. d1), Etoposid (100 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5)', 'interventionNames': ['Biological: filgrastim', 'Drug: EPOCH regimen', 'Drug: cyclophosphamide', 'Drug: doxorubicin hydrochloride', 'Drug: etoposide', 'Drug: prednisone', 'Drug: vincristine sulfate', 'Radiation: radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'high CHOEP-21', 'description': 'High-CHOEP-21-Schema:\n\nCyclophosphamid (1400 mg/m2 i.v. d1), Doxorubicin (32,5 mg/m2 i.v. d1+2), Vincristin (2 mg i.v. d1), Etoposid (175 mg/m² i.v. d1-3), Prednison (100 mg p.o. d1-5)', 'interventionNames': ['Biological: filgrastim', 'Drug: EPOCH regimen', 'Drug: cyclophosphamide', 'Drug: doxorubicin hydrochloride', 'Drug: etoposide', 'Drug: prednisone', 'Drug: vincristine sulfate', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'filgrastim', 'type': 'BIOLOGICAL', 'armGroupLabels': ['CHOEP-21', 'high CHOEP-21']}, {'name': 'EPOCH regimen', 'type': 'DRUG', 'armGroupLabels': ['CHOEP-21', 'high CHOEP-21']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'armGroupLabels': ['CHOEP-21', 'high CHOEP-21']}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['CHOEP-21', 'high CHOEP-21']}, {'name': 'etoposide', 'type': 'DRUG', 'armGroupLabels': ['CHOEP-21', 'high CHOEP-21']}, {'name': 'prednisone', 'type': 'DRUG', 'armGroupLabels': ['CHOEP-21', 'high CHOEP-21']}, {'name': 'vincristine sulfate', 'type': 'DRUG', 'armGroupLabels': ['CHOEP-21', 'high CHOEP-21']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'armGroupLabels': ['CHOEP-21', 'high CHOEP-21']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52070', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Haematologisch Onkologische Praxis', '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': 'D-91522', 'city': 'Ansbach', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie', 'geoPoint': {'lat': 49.30481, 'lon': 10.5931}}, {'zip': '63739', 'city': 'Aschaffenburg', 'country': 'Germany', 'facility': 'Specialist Practice for Oncology', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'zip': 'D-63739', 'city': 'Aschaffenburg', 'country': 'Germany', 'facility': 'II. 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