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Sponsors and Collaborators: |
European Organization for Research and Treatment of Cancer Lymphoma Trials Office Groupe d'Etudes de Lymphomes de L'Adulte Grup per l'Estudi dels Limfomes de Catalunya i Balears National Cancer Institute of Canada Australasian Leukaemia and Lymphoma Group (ALLG) Nordic Lymphoma Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00049595 |
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 | Intervention | Phase |
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Lymphoma |
Drug: ABVD regimen Drug: bleomycin Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: pegfilgrastim Drug: prednisone Drug: procarbazine hydrochloride Drug: vinblastine Drug: vincristine sulfate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma |
Estimated Enrollment: | 550 |
Study Start Date: | August 2002 |
OBJECTIVES:
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.
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.
Ages Eligible for Study: | 16 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed Hodgkin's lymphoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Investigator: | Patrice P. Carde, MD | Institut Gustave Roussy |
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 |
Investigator: | David Ma, MD | St. Vincent’s Hospital. |
Investigator: | Devinder Gill, MD | Princess Alexandra Hospital |
Study Chair: | Bengt Glimelius, MD | Uppsala University Hospital |
Study ID Numbers: | CDR0000258125, EORTC-20012, GELA-EORTC-20012, BNLI-EORTC-20012, GELCAB-EORTC-20012, NORDICLG-EORTC-20012, CAN-NCIC-EORTC-20012, ALLG-HD04 |
Study First Received: | November 12, 2002 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00049595 |
Health Authority: | Unspecified |
adult lymphocyte depletion Hodgkin lymphoma adult mixed cellularity Hodgkin lymphoma adult nodular sclerosis Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma |
Prednisone Dacarbazine Immunoproliferative Disorders Hodgkin's disease Hodgkin lymphoma, adult Vincristine Sclerosis Vinblastine Cyclophosphamide |
Bleomycin Etoposide phosphate Doxorubicin Lymphatic Diseases Procarbazine Lymphoproliferative Disorders Etoposide Lymphoma Hodgkin Disease |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antimitotic Agents Antibiotics, Antineoplastic |
Hormones Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |