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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) Southwest Oncology Group National Cancer Institute of Canada Cancer and Leukemia Group B |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003389 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining more than one drug with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work, with or without radiation therapy, in treating patients with Hodgkin's lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Drug: ABVD regimen Drug: Stanford V regimen Drug: bleomycin Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide Drug: mechlorethamine hydrochloride Drug: prednisone Drug: vinblastine Drug: vincristine sulfate Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase III Trial of ABVD Versus Stanford V(+/-) Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease Without High Risk Features |
Estimated Enrollment: | 850 |
Study Start Date: | November 2000 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to number of adverse risk factors (0-2 vs 3-7) and disease characteristics (locally extensive vs advanced). Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 850 patients will be accrued for this study within 4.3 years.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven previously untreated classical Hodgkin's lymphoma of the following subtypes:
The following stages are eligible:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Sandra J. Horning, MD | Stanford University |
Study Chair: | Richard I. Fisher, MD | James P. Wilmot Cancer Center |
Study Chair: | Joseph M. Connors, MD | British Columbia Cancer Agency |
Study Chair: | Nancy L. Bartlett, MD | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
Study ID Numbers: | CDR0000066386, ECOG-2496, CAN-NCIC-HD7, CALGB-59905, SWOG-E2496 |
Study First Received: | November 1, 1999 |
Last Updated: | January 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00003389 |
Health Authority: | United States: Federal Government |
stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma |
adult lymphocyte depletion Hodgkin lymphoma adult nodular sclerosis Hodgkin lymphoma adult mixed cellularity Hodgkin lymphoma |
Prednisone Dacarbazine Immunoproliferative Disorders Hodgkin's disease Hodgkin lymphoma, adult Vincristine Sclerosis Vinblastine Cyclophosphamide |
Bleomycin Etoposide phosphate Doxorubicin Lymphatic Diseases Mechlorethamine Lymphoproliferative Disorders Etoposide Lymphoma Hodgkin Disease |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors 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 |