Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
European Organization for Research and Treatment of Cancer |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00379041 |
RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with combination chemotherapy may kill more cancer cells. It is not yet known whether radiation therapy is more effective with or without combination chemotherapy in treating patients with Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works with or without combination chemotherapy in treating patients with previously untreated stage I or stage II Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: bleomycin Drug: doxorubicin hydrochloride Drug: mechlorethamine hydrochloride Drug: prednisone Drug: procarbazine hydrochloride Drug: vinblastine Drug: vincristine sulfate Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Protocol H8 for a Prospective Controlled Trial in Clinical Stage I-II Supradiaphragmatic Hodgkin's Disease. Evaluation of Treatment Efficacy and (Long Term) Toxicity in Three Different Prognostic Subgroups [H8 Trial] |
Estimated Enrollment: | 1158 |
Study Start Date: | September 1993 |
OBJECTIVES:
OUTLINE: This is a randomized, controlled, prospective, multicenter study. Patients are stratified according to prognosis (favorable vs unfavorable vs very favorable).
Stratum 2 (favorable prognosis): Patients are randomized to 1 of 2 treatment arms.
Stratum 3 (unfavorable prognosis): Patients are randomized to 1 of 3 treatment arms.
Quality of life is assessed after completion of study treatment and then annually for 10 years.
After completion of study treatment, patients are followed at 2, 4, 6, 9, and 12 months, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,158 patients will be accrued for this study.
Ages Eligible for Study: | 15 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed supradiaphragmatic Hodgkin's lymphoma
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000504418, EORTC-20931 |
Study First Received: | September 20, 2006 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00379041 |
Health Authority: | United States: Federal Government |
stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma |
Prednisone Immunoproliferative Disorders Hodgkin's disease Hodgkin lymphoma, adult Vincristine Vinblastine Bleomycin |
Doxorubicin Lymphatic Diseases Mechlorethamine Procarbazine Lymphoproliferative Disorders Lymphoma Hodgkin Disease |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antimitotic Agents |
Antibiotics, Antineoplastic Glucocorticoids Hormones Pharmacologic Actions Neoplasms Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents |