Overview

This trial is active, not recruiting.

Condition lymphoma
Treatments bleomycin sulfate, filgrastim, pegfilgrastim, abvd regimen, beacopp regimen, cyclophosphamide, dacarbazine, doxorubicin hydrochloride, etoposide, prednisone, procarbazine hydrochloride, vinblastine sulfate, vincristine sulfate
Phase phase 3
Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Collaborator Lymphoma Trials Office
Start date August 2002
End date January 2010
Trial size 552 participants
Trial identifier NCT00049595, 2004-001558-10, ALLG-HD04, BNLI-EORTC-20012, CAN-NCIC-EORTC-20012, EORTC-20012, GELA-EORTC-20012, GELCAB-EORTC-20012, NORDICLG-EORTC-20012

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
8 cycles of ABVD
bleomycin sulfate
abvd regimen
dacarbazine
doxorubicin hydrochloride
vinblastine sulfate
(Experimental)
4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline
bleomycin sulfate
filgrastim
pegfilgrastim
beacopp regimen
cyclophosphamide
doxorubicin hydrochloride
etoposide
prednisone
procarbazine hydrochloride
vincristine sulfate

Primary Outcomes

Measure
Event-free survival
time frame: from randomization to early discontinuation of protocol treatment, no CR/CRu after 8 cycles, relapse, progression or death

Secondary Outcomes

Measure
Complete response as assessed by Cheson criteria adapted to Hodgkin's lymphoma
time frame: from randomization till end of treatment
Disease-free survival in patients with complete response
time frame: from the day of first documentation of CR to the day of relapse
Overall survival
time frame: from the date of randomization to the date of death
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
time frame: from one week prior to randomization till 10 years after end of treatment or death

Eligibility Criteria

Male or female participants from 16 years up to 60 years old.

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

Additional Information

Official title BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma
Description OBJECTIVES: - 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. - Compare complete response, disease-free survival, and overall survival of patients treated with these regimens. - Compare quality of life of patients treated with these regimens. - Compare occurrence of second malignancies in patients treated with these regimens. OUTLINE: 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. - 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. - 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. Quality of life is assessed at baseline, at the end of therapy, and then annually for 10 years. Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 550 patients (225 per treatment arm) will be accrued for this study within 5.5 years.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by European Organisation for Research and Treatment of Cancer - EORTC.