Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2025-12-31 @ 1:27 AM
Study NCT ID:
NCT00049595
Status:
COMPLETED
Last Update Posted:
2025-08-05
First Post:
2002-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001761', 'term': 'Bleomycin'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'C455861', 'term': 'pegfilgrastim'}, {'id': 'C034632', 'term': 'ABVD protocol'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D011344', 'term': 'Procarbazine'}, {'id': 'D014747', 'term': 'Vinblastine'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling 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': 'D014226', 'term': 'Triazenes'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic 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': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 552}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2002-11-12', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free survival', 'timeFrame': 'from randomization to early discontinuation of protocol treatment, no CR/CRu after 8 cycles, relapse, progression or death'}], 'secondaryOutcomes': [{'measure': "Complete response as assessed by Cheson criteria adapted to Hodgkin's lymphoma", 'timeFrame': 'from randomization till end of treatment'}, {'measure': 'Disease-free survival in patients with complete response', 'timeFrame': 'from the day of first documentation of CR to the day of relapse'}, {'measure': 'Overall survival', 'timeFrame': 'from the date of randomization to the date of death'}, {'measure': 'Quality of life as assessed by European Organization for Research of the Treatment of Cancer (EORTC) Quality of Life Questionnaire (QoLQ) C30 version 3.0', 'timeFrame': 'from one week prior to randomization till 10 years after end of treatment or death'}]}, 'conditionsModule': {'keywords': ['adult lymphocyte depletion Hodgkin lymphoma', 'adult mixed cellularity Hodgkin lymphoma', 'adult nodular sclerosis Hodgkin lymphoma', 'stage III adult Hodgkin lymphoma', 'stage IV adult Hodgkin lymphoma'], 'conditions': ['Lymphoma']}, 'referencesModule': {'references': [{'pmid': '27114593', 'type': 'DERIVED', 'citation': 'Carde P, Karrasch M, Fortpied C, Brice P, Khaled H, Casasnovas O, Caillot D, Gaillard I, Bologna S, Ferme C, Lugtenburg PJ, Morschhauser F, Aurer I, Coiffier B, Meyer R, Seftel M, Wolf M, Glimelius B, Sureda A, Mounier N. Eight Cycles of ABVD Versus Four Cycles of BEACOPPescalated Plus Four Cycles of BEACOPPbaseline in Stage III to IV, International Prognostic Score >/= 3, High-Risk Hodgkin Lymphoma: First Results of the Phase III EORTC 20012 Intergroup Trial. J Clin Oncol. 2016 Jun 10;34(17):2028-36. doi: 10.1200/JCO.2015.64.5648. Epub 2016 Apr 25.'}]}, '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 may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating stage III or stage IV Hodgkin's lymphoma.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage III or stage IV Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\n* Compare event-free survival of patients with stage III or IV Hodgkin's lymphoma treated with bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone vs doxorubicin, bleomycin, vinblastine, and dacarbazine.\n* Compare complete response, disease-free survival, and overall survival of patients treated with these regimens.\n* Compare quality of life of patients treated with these regimens.\n* Compare occurrence of second malignancies in patients treated with these regimens.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to International Prognostic Score (3 vs 4 or more) and participating center. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I (BEACOPP): Patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV on day 1; etoposide IV over 30 minutes on days 1-3; oral procarbazine on days 1-7; oral prednisone on days 1-14; and vincristine IV and bleomycin IV or intramuscularly (IM) on day 8. Patients may receive dexamethasone in place of prednisone. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 9 and continuing until blood counts recover or pegfilgrastim SC on day 9 only. Treatment repeats every 22 days for 8 courses (4 courses escalated dose followed by 4 courses baseline dose) in the absence of disease progression or unacceptable toxicity.\n* Arm II (ABVD): Patients receive doxorubicin IV over 5 minutes, bleomycin IV or IM, vinblastine IV, and dacarbazine IV over 5-10 minutes on days 1 and 15. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed at baseline, at the end of therapy, and then annually for 10 years.\n\nPatients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 550 patients (225 per treatment arm) will be accrued for this study within 5.5 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed Hodgkin's lymphoma\n\n * No lymphocyte predominant, nodular type (nodular paragranuloma)\n * Clinical stage III or IV disease\n* At least 1 bidimensionally measurable target lesion or extranodal lesion\n* International Prognostic Score of at least 3\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 16 to 60\n\nPerformance status\n\n* WHO 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* WBC greater than 2,000/mm\\^3\n* Platelet count greater than 100,000/mm\\^3\n\nHepatic\n\n* No prior uncontrolled hepatitis B viral infection\n* Bilirubin no greater than 2.5 times normal (unless due to Hodgkin's lymphoma)\n\nRenal\n\n* Creatinine no greater than 2.0 mg/dL (unless due to Hodgkin's lymphoma)\n\nCardiovascular\n\n* No severe cardiac disease that would limit normal life expectancy or preclude study\n* LVEF at least 50%\n\nPulmonary\n\n* No severe pulmonary disease that would limit normal life expectancy or preclude study\n* Respiratory function at least 30%\n\nOther\n\n* HIV negative\n* HTLV1 negative\n* No severe active infection\n* No severe neurological or metabolic disease that would limit normal life expectancy or preclude study\n* No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix\n* No psychological, familial, sociological, or geographical condition that would preclude study\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No concurrent radiotherapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* No prior therapy for Hodgkin's lymphoma"}, 'identificationModule': {'nctId': 'NCT00049595', 'briefTitle': "Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma", 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': "BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'EORTC-20012'}, 'secondaryIdInfos': [{'id': 'EORTC-20012', 'type': 'OTHER', 'domain': 'EORTC'}, {'id': 'GELA-EORTC-20012', 'type': 'OTHER', 'domain': 'GELA'}, {'id': 'BNLI-EORTC-20012', 'type': 'OTHER', 'domain': 'BNLI'}, {'id': 'GELCAB-EORTC-20012', 'type': 'OTHER', 'domain': 'GELCAB'}, {'id': 'NORDICLG-EORTC-20012', 'type': 'OTHER', 'domain': 'NLG'}, {'id': 'CAN-NCIC-EORTC-20012', 'type': 'OTHER', 'domain': 'NCIC CTG'}, {'id': 'ALLG-HD04', 'type': 'OTHER', 'domain': 'ALLG'}, {'id': '2004-001558-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ABVD', 'description': '8 cycles of ABVD', 'interventionNames': ['Biological: bleomycin sulfate', 'Drug: ABVD regimen', 'Drug: dacarbazine', 'Drug: doxorubicin hydrochloride', 'Drug: vinblastine sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'BEACOPP', 'description': '4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline', 'interventionNames': ['Biological: bleomycin sulfate', 'Biological: filgrastim', 'Biological: pegfilgrastim', 'Drug: BEACOPP regimen', 'Drug: cyclophosphamide', 'Drug: doxorubicin hydrochloride', 'Drug: etoposide', 'Drug: prednisone', 'Drug: procarbazine hydrochloride', 'Drug: vincristine sulfate']}], 'interventions': [{'name': 'bleomycin sulfate', 'type': 'BIOLOGICAL', 'armGroupLabels': ['ABVD', 'BEACOPP']}, {'name': 'filgrastim', 'type': 'BIOLOGICAL', 'armGroupLabels': ['BEACOPP']}, {'name': 'pegfilgrastim', 'type': 'BIOLOGICAL', 'armGroupLabels': ['BEACOPP']}, {'name': 'ABVD regimen', 'type': 'DRUG', 'armGroupLabels': ['ABVD']}, {'name': 'BEACOPP regimen', 'type': 'DRUG', 'armGroupLabels': ['BEACOPP']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'armGroupLabels': ['BEACOPP']}, {'name': 'dacarbazine', 'type': 'DRUG', 'armGroupLabels': ['ABVD']}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['ABVD', 'BEACOPP']}, {'name': 'etoposide', 'type': 'DRUG', 'armGroupLabels': ['BEACOPP']}, {'name': 'prednisone', 'type': 'DRUG', 'armGroupLabels': ['BEACOPP']}, {'name': 'procarbazine hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['BEACOPP']}, {'name': 'vinblastine sulfate', 'type': 'DRUG', 'armGroupLabels': ['ABVD']}, {'name': 'vincristine sulfate', 'type': 'DRUG', 'armGroupLabels': ['BEACOPP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2606', 'city': 'Garran', 'state': 'Australian Capital Territory', 'country': 'Australia', 'facility': 'Canberra Hospital', 'geoPoint': {'lat': -35.34206, 'lon': 149.10846}}, {'zip': '2747', 'city': 'Kingswood', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Nepean Cancer Care Centre at Nepean Hospital', 'geoPoint': {'lat': -33.75614, 'lon': 150.72346}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Institute for Cancer Research at Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4102', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'facility': "St. Vincent's Hospital - Melbourne", 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '6000', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Royal Perth Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Ziekenhuis Netwerk Antwerpen Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'AZ Sint-Jan', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hopital Universitaire Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'B 1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '6000', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'Centre Hospitalier Notre Dame - Reine Fabiola', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': 'B-2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': 'B-9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Sint Lucas', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '7100', 'city': 'Haine-Saint-Paul', 'country': 'Belgium', 'facility': 'Hopital de Jolimont', 'geoPoint': {'lat': 50.45544, 'lon': 4.1885}}, {'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'U.Z. Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Centre Hospitalier Regional de la Citadelle', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '8800', 'city': 'Roeselare', 'country': 'Belgium', 'facility': 'H. 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