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Health Condition(s) or Problem
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Lymphoma
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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Biological; bleomycin sulfate; Biological; filgrastim; Biological; pegfilgrastim; Drug; ABVD regimen; Drug; BEACOPP regimen; Drug; cyclophosphamide; Drug; dacarbazine; Drug; doxorubicin hydrochloride; Drug; etoposide; Drug; prednisone; Drug; procarbazine hydrochloride; Drug; vinblastine sulfate; Drug; vincristine sulfate
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Primary aim
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Event-free survival
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Secondary Aim
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Complete response as assessed by Cheson criteria adapted to Hodgkin's lymphoma; No; Disease-free survival in patients with complete response; No; Overall survival; No; 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; No; Occurrence of secondary malignancies; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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http://cancer.gov/clinicaltrials/EORTC-20012
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Recruitment Status
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Not Recruiting
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Nation
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England
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Location
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Birmingham, Canterbury, Hull, Kettering, Leicester, London, Northwood, Nottingham, Sheffield , Stafford
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