Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT00265018
Status:
COMPLETED
Last Update Posted:
2011-07-29
First Post:
2005-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HD10 for Early Stages
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D001761', 'term': 'Bleomycin'}, {'id': 'D014747', 'term': 'Vinblastine'}, {'id': 'D003606', 'term': 'Dacarbazine'}], 'ancestors': [{'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': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'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': 'D014226', 'term': 'Triazenes'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1370}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'lastUpdateSubmitDate': '2011-07-28', 'studyFirstSubmitDate': '2005-12-12', 'studyFirstSubmitQcDate': '2005-12-12', 'lastUpdatePostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': '5 years'}]}, 'conditionsModule': {'keywords': ['Hodgkin´s lymphoma', 'early stages'], 'conditions': ['Hodgkin´s Lymphoma']}, 'referencesModule': {'references': [{'pmid': '20818855', 'type': 'RESULT', 'citation': "Engert A, Plutschow A, Eich HT, Lohri A, Dorken B, Borchmann P, Berger B, Greil R, Willborn KC, Wilhelm M, Debus J, Eble MJ, Sokler M, Ho A, Rank A, Ganser A, Trumper L, Bokemeyer C, Kirchner H, Schubert J, Kral Z, Fuchs M, Muller-Hermelink HK, Muller RP, Diehl V. Reduced treatment intensity in patients with early-stage Hodgkin's lymphoma. N Engl J Med. 2010 Aug 12;363(7):640-52. doi: 10.1056/NEJMoa1000067."}, {'pmid': '29989855', 'type': 'DERIVED', 'citation': 'Sasse S, Goergen H, Plutschow A, Boll B, Eichenauer DA, Fuchs M, Behringer K, Zijlstra JM, Greil R, Markova J, Topp MS, Meissner J, Neubauer A, Baues C, Engert A, Borchmann P, von Tresckow B. Outcome of Patients With Early-Stage Infradiaphragmatic Hodgkin Lymphoma: A Comprehensive Analysis From the German Hodgkin Study Group. J Clin Oncol. 2018 Sep 1;36(25):2603-2611. doi: 10.1200/JCO.2018.78.7192. Epub 2018 Jul 10.'}, {'pmid': '26834240', 'type': 'DERIVED', 'citation': 'Boll B, Goergen H, Behringer K, Brockelmann PJ, Hitz F, Kerkhoff A, Greil R, von Tresckow B, Eichenauer DA, Burkle C, Borchmann S, Fuchs M, Diehl V, Engert A, Borchmann P. Bleomycin in older early-stage favorable Hodgkin lymphoma patients: analysis of the German Hodgkin Study Group (GHSG) HD10 and HD13 trials. Blood. 2016 May 5;127(18):2189-92. doi: 10.1182/blood-2015-11-681064. Epub 2016 Feb 1.'}, {'pmid': '24121121', 'type': 'DERIVED', 'citation': 'Hay AE, Klimm B, Chen BE, Goergen H, Shepherd LE, Fuchs M, Gospodarowicz MK, Borchmann P, Connors JM, Markova J, Crump M, Lohri A, Winter JN, Dorken B, Pearcey RG, Diehl V, Horning SJ, Eich HT, Engert A, Meyer RM; Conducted by the NCIC Clinical Trials Group (Canada) and German Hodgkin Study Group (GHSG). An individual patient-data comparison of combined modality therapy and ABVD alone for patients with limited-stage Hodgkin lymphoma. Ann Oncol. 2013 Dec;24(12):3065-9. doi: 10.1093/annonc/mdt389. Epub 2013 Oct 11.'}, {'pmid': '23509310', 'type': 'DERIVED', 'citation': 'Boll B, Gorgen H, Fuchs M, Pluetschow A, Eich HT, Bargetzi MJ, Weidmann E, Junghanss C, Greil R, Scherpe A, Schmalz O, Eichenauer DA, von Tresckow B, Rothe A, Diehl V, Engert A, Borchmann P. ABVD in older patients with early-stage Hodgkin lymphoma treated within the German Hodgkin Study Group HD10 and HD11 trials. J Clin Oncol. 2013 Apr 20;31(12):1522-9. doi: 10.1200/JCO.2012.45.4181. Epub 2013 Mar 18.'}], 'seeAlsoLinks': [{'url': 'http://www.lymphome.de/Gruppen/GHSG/', 'label': 'Description of study in Gereman (Website of the Competence Network Malignant Lymphoma'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to find the optimum radiation dose and number of cycles for an ABVD chemotherapy combined with an involved field irradiation. It is to be tested whether the reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20 Gy is feasible without a loss of efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hodgkin´s lymphoma (histologically proven)\n* CS (PS) IA, IB, IIA,IIB without any of the following risk factors:\n\n 1. bulky mediastinal mass (\\> 1/3 maximum transverse thorax diameter)\n 2. extranodal involvement\n 3. ESR \\> 50 (A), \\> 30 (B-symptoms)\n 4. 3 or more lymph node areas involved\n* written informaed consent\n\nExclusion Criteria:\n\n* Leukocytes \\<3000/microl\n* Platelets \\<100000/microl\n* Hodgkin´s Disease as "composite lymphoma"\n* Activity index (WHO) \\< grade 2'}, 'identificationModule': {'nctId': 'NCT00265018', 'briefTitle': 'HD10 for Early Stages', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'orgStudyIdInfo': {'id': 'HD10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A', 'interventionNames': ['Drug: Adriamycin', 'Drug: Bleomycin', 'Drug: Vinblastine', 'Drug: DTIC', 'Radiation: 30 Gy IF-RT']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'interventionNames': ['Drug: Adriamycin', 'Drug: Bleomycin', 'Drug: Vinblastine', 'Drug: DTIC', 'Radiation: 20 Gy IF-RT']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C', 'interventionNames': ['Drug: Adriamycin', 'Drug: Bleomycin', 'Drug: Vinblastine', 'Drug: DTIC', 'Radiation: 30 Gy IF-RT']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D', 'interventionNames': ['Drug: Adriamycin', 'Drug: Bleomycin', 'Drug: Vinblastine', 'Drug: DTIC', 'Radiation: 20 Gy IF-RT']}], 'interventions': [{'name': 'Adriamycin', 'type': 'DRUG', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C', 'Arm D']}, {'name': 'Bleomycin', 'type': 'DRUG', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C', 'Arm D']}, {'name': 'Vinblastine', 'type': 'DRUG', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C', 'Arm D']}, {'name': 'DTIC', 'type': 'DRUG', 'armGroupLabels': ['Arm A', 'Arm B', 'Arm C', 'Arm D']}, {'name': '30 Gy IF-RT', 'type': 'RADIATION', 'armGroupLabels': ['Arm A', 'Arm C']}, {'name': '20 Gy IF-RT', 'type': 'RADIATION', 'armGroupLabels': ['Arm B', 'Arm D']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Volker Diehl, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cologne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}}}}