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
- 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
Quality of life is assessed at baseline, at the end of therapy, and then annually for 10
Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then
PROJECTED ACCRUAL: A total of 550 patients (225 per treatment arm) will be accrued for this
study within 5.5 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Study Arm Groups : ABVD, BEACOPP, BEACOPP, BEACOPP, ABVD, BEACOPP, BEACOPP, ABVD, ABVD, BEACOPP, BEACOPP, BEACOPP, BEACOPP, ABVD, BEACOPP
See Interventions above
- Event-free survival; null
- 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
Sorry, this information is not available
This is available on the Clinicaltrials.gov
16 Years - 60 Years
Sorry, this information is not available
This is in the inclusion criteria above
BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma
Not available for this trial
- 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
European Organisation for Research and Treatment of Cancer - EORTC