Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00049595|
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : July 27, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||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||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||552 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma|
|Study Start Date :||August 2002|
|Primary Completion Date :||January 2010|
Active Comparator: ABVD
8 cycles of ABVD
|Biological: bleomycin sulfate Drug: ABVD regimen Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: vinblastine sulfate|
4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline
|Biological: bleomycin sulfate Biological: filgrastim Biological: pegfilgrastim Drug: BEACOPP regimen Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: procarbazine hydrochloride Drug: vincristine sulfate|
- Event-free survival [ Time Frame: from randomization to early discontinuation of protocol treatment, no CR/CRu after 8 cycles, relapse, progression or death ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049595
Show 140 Study Locations
|Study Chair:||Patrice P. Carde, MD||Gustave Roussy, Cancer Campus, Grand Paris|
|Study Chair:||David C. Linch||Middlesex Hospital|
|Study Chair:||Marine Divine, MD||Centre Hospitalier Universitaire Henri Mondor|
|Study Chair:||Anna Sureda||Hospital de la Santa Cruz i Sant Pau|
|Study Chair:||Ralph M. Meyer, MD, FRCPC||Margaret and Charles Juravinski Cancer Centre|
|Study Chair:||David Ma, MD||St. Vincent's Medical Center|
|Study Chair:||Devinder Gill, MD||Princess Alexandra Hospital|
|Study Chair:||Bengt Glimelius, MD||Uppsala University Hospital|