Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Biological: bleomycin sulfateBiological: filgrastimDrug: ABVD regimenBiological: pegfilgrastimDrug: BEACOPP regimen
- Registration Number
- NCT00049595
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 552
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABVD dacarbazine 8 cycles of ABVD ABVD doxorubicin hydrochloride 8 cycles of ABVD ABVD vinblastine sulfate 8 cycles of ABVD BEACOPP bleomycin sulfate 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline BEACOPP filgrastim 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline BEACOPP pegfilgrastim 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline BEACOPP BEACOPP regimen 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline ABVD bleomycin sulfate 8 cycles of ABVD ABVD ABVD regimen 8 cycles of ABVD BEACOPP doxorubicin hydrochloride 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline BEACOPP etoposide 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline BEACOPP prednisone 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline BEACOPP procarbazine hydrochloride 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline BEACOPP vincristine sulfate 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline BEACOPP cyclophosphamide 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline
- Primary Outcome Measures
Name Time Method Event-free survival from randomization to early discontinuation of protocol treatment, no CR/CRu after 8 cycles, relapse, progression or death
- Secondary Outcome Measures
Name Time Method Complete response as assessed by Cheson criteria adapted to Hodgkin's lymphoma from randomization till end of treatment Disease-free survival in patients with complete response from the day of first documentation of CR to the day of relapse Overall survival 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 from one week prior to randomization till 10 years after end of treatment or death
Trial Locations
- Locations (140)
Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
Nepean Cancer Care Centre at Nepean Hospital
🇦🇺Kingswood, New South Wales, Australia
Westmead Institute for Cancer Research at Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia
St. Vincent's Hospital - Melbourne
🇦🇺Fitzroy, Victoria, Australia
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Ziekenhuis Netwerk Antwerpen Middelheim
🇧🇪Antwerp, Belgium
AZ Sint-Jan
🇧🇪Brugge, Belgium
Institut Jules Bordet
🇧🇪Brussels, Belgium
Scroll for more (130 remaining)Canberra Hospital🇦🇺Garran, Australian Capital Territory, Australia