Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma | Not Recruiting
Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma
Health Conditions
  • Lymphoma
Not Recruiting
Recruitment Status
NCT00049595
Primary Trial ID Number
Summary
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. PURPOSE: 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.
Primary Outcome Measures
  • Event-free survival; null
Secondary Outcome Measures
  • Complete response as assessed by Cheson criteria adapted to Hodgkin's lymphoma; null; Disease-free survival in patients with complete response; null; Overall survival; null; 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; null; Occurrence of secondary malignancies; null
Research Question
  • 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. PURPOSE: 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.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
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Countries of Recruitment
Australia; Belgium; Canada; Croatia; Czech Republic; France; Hungary; Netherlands; New Zealand; Poland; Spain; Sweden; United Kingdom
Participant Sex
Both
Participant Age Range
16 Years to 60 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
Sorry, this information is not available
Participant Inclusion Criteria
  • DISEASE CHARACTERISTICS:
  • - Histologically confirmed Hodgkin's lymphoma
  • - No lymphocyte predominant, nodular type (nodular paragranuloma)
  • - Clinical stage III or IV disease
  • - At least 1 bidimensionally measurable target lesion or extranodal lesion
  • - International Prognostic Score of at least 3
  • PATIENT CHARACTERISTICS:
  • Age
  • - 16 to 60
  • Performance status
  • - WHO 0-2
  • Life expectancy
  • - Not specified
  • Hematopoietic
  • - WBC greater than 2,000/mm^3
  • - Platelet count greater than 100,000/mm^3
  • Hepatic
  • - No prior uncontrolled hepatitis B viral infection
  • - Bilirubin no greater than 2.5 times normal (unless due to Hodgkin's lymphoma)
  • Renal
  • - Creatinine no greater than 2.0 mg/dL (unless due to Hodgkin's lymphoma)
  • Cardiovascular
  • - No severe cardiac disease that would limit normal life expectancy or preclude study
  • - LVEF at least 50%
  • Pulmonary
  • - No severe pulmonary disease that would limit normal life expectancy or preclude study
  • - Respiratory function at least 30%
  • Other
  • - HIV negative
  • - HTLV1 negative
  • - No severe active infection
  • - No severe neurological or metabolic disease that would limit normal life expectancy
  • or preclude study
  • - No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in
  • situ of the cervix
  • - No psychological, familial, sociological, or geographical condition that would
  • preclude study
  • - Not pregnant or nursing
  • - Fertile patients must use effective contraception
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • - Not specified
  • Chemotherapy
  • - Not specified
  • Endocrine therapy
  • - Not specified
  • Radiotherapy
  • - No concurrent radiotherapy
  • Surgery
  • - Not specified
  • Other
  • - No prior therapy for Hodgkin's lymphoma
Participant Exclusion Criteria
  • DISEASE CHARACTERISTICS:
  • - Histologically confirmed Hodgkin's lymphoma
  • - No lymphocyte predominant, nodular type (nodular paragranuloma)
  • - Clinical stage III or IV disease
  • - At least 1 bidimensionally measurable target lesion or extranodal lesion
  • - International Prognostic Score of at least 3
  • PATIENT CHARACTERISTICS:
  • Age
  • - 16 to 60
  • Performance status
  • - WHO 0-2
  • Life expectancy
  • - Not specified
  • Hematopoietic
  • - WBC greater than 2,000/mm^3
  • - Platelet count greater than 100,000/mm^3
  • Hepatic
  • - No prior uncontrolled hepatitis B viral infection
  • - Bilirubin no greater than 2.5 times normal (unless due to Hodgkin's lymphoma)
  • Renal
  • - Creatinine no greater than 2.0 mg/dL (unless due to Hodgkin's lymphoma)
  • Cardiovascular
  • - No severe cardiac disease that would limit normal life expectancy or preclude study
  • - LVEF at least 50%
  • Pulmonary
  • - No severe pulmonary disease that would limit normal life expectancy or preclude study
  • - Respiratory function at least 30%
  • Other
  • - HIV negative
  • - HTLV1 negative
  • - No severe active infection
  • - No severe neurological or metabolic disease that would limit normal life expectancy
  • or preclude study
  • - No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in
  • situ of the cervix
  • - No psychological, familial, sociological, or geographical condition that would
  • preclude study
  • - Not pregnant or nursing
  • - Fertile patients must use effective contraception
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • - Not specified
  • Chemotherapy
  • - Not specified
  • Endocrine therapy
  • - Not specified
  • Radiotherapy
  • - No concurrent radiotherapy
  • Surgery
  • - Not specified
  • Other
  • - No prior therapy for Hodgkin's lymphoma
Interventions
Biological; bleomycin sulfate; null; [ABVD, BEACOPP]; Biological; filgrastim; null; [BEACOPP]; Biological; pegfilgrastim; null; [BEACOPP]; Drug; ABVD regimen; null; [ABVD]; Drug; BEACOPP regimen; null; [BEACOPP]; Drug; cyclophosphamide; null; [BEACOPP]; Drug; dacarbazine; null; [ABVD]; Drug; doxorubicin hydrochloride; null; [ABVD, BEACOPP]; Drug; etoposide; null; [BEACOPP]; Drug; prednisone; null; [BEACOPP]; Drug; procarbazine hydrochloride; null; [BEACOPP]; Drug; vinblastine sulfate; null; [ABVD]; Drug; vincristine sulfate; null; [BEACOPP]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
Sorry, this information is not available
Scientific Title
BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma
Secondary Trial Identifying Number
EORTC-20012; GELA-EORTC-20012; BNLI-EORTC-20012; GELCAB-EORTC-20012; NORDICLG-EORTC-20012; CAN-NCIC-EORTC-20012; ALLG-HD04; 2004-001558-10
Website
http://cancer.gov/clinicaltrials/EORTC-20012
Study Funded By
European Organisation for Research and Treatment of Cancer - EORTC
Funder Type
Sorry, this information is not available
Study Sponsored By
European Organisation for Research and Treatment of Cancer - EORTC
Study Also Sponsored By
Lymphoma Trials Office; Lymphoma Study Association; Grup per l'Estudi dels Limfomes de Catalunya i Balears; NCIC Clinical Trials Group; Australasian Leukaemia and Lymphoma Group; Nordic Lymphoma Group
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

12 Nov 2002

Last Updated

13 Jun 2014

Date Record Refreshed on UKCTG

24 Jul 2015