SWOG-9133 RT w/ or w/o Doxorubicin and Vinblastine in Stage I or Stage II Hodgkin's Disease
- Conditions
- Lymphoma
- Interventions
- Registration Number
- NCT00002495
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without doxorubicin and vinblastine in treating patients with stage I or stage II Hodgkin's disease.
- Detailed Description
OBJECTIVES: I. Compare progression-free and overall survival of patients with clinical Stage IA/IIA Hodgkin's disease who have not undergone laparotomy and who are randomized to treatment with subtotal nodal irradiation with vs. without 3 courses of doxorubicin/vinblastine. II. Compare the long-term toxicities associated with these treatments, including cardiopulmonary toxicity, secondary malignancies, and infertility. III. Identify subgroups of patients (based on age, gender, tumor histology, number of disease sites, and presence of high neck presentation) that are particularly responsive to these treatments.
OUTLINE: Randomized study. Arm I: Radiotherapy. Subtotal nodal irradiation using megavoltage equipment (4-10 MeV). Arm II: 2-Drug Combination Chemotherapy followed by Radiotherapy. Doxorubicin, DOX, NSC-123127; Vinblastine, VBL, NSC-49842; followed by subtotal nodal irradiation as in Arm I.
PROJECTED ACCRUAL: 210 patients/arm will be enrolled over about 7 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 348
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chemotherapy + Nodal RT doxorubicin hydrochloride 3 cycles (28 days each) of chemotherapy (doxorubicin 25 mg/m\^2 on days 1 and 15, vinblastine 6 mg/m\^2 on days 1 and 15). Four weeks after last cycle, subtotal nodal irradiation (total dose 3600-4000 cGy over 20 fractions) will be given as described for the Nodal RT arm. Chemotherapy + Nodal RT standard subtotal nodal irradiation 3 cycles (28 days each) of chemotherapy (doxorubicin 25 mg/m\^2 on days 1 and 15, vinblastine 6 mg/m\^2 on days 1 and 15). Four weeks after last cycle, subtotal nodal irradiation (total dose 3600-4000 cGy over 20 fractions) will be given as described for the Nodal RT arm. Nodal RT standard subtotal nodal irradiation subtotal nodal irradiation will consist of mantle and periaortic/spleen fields treated sequentially. Total dose 3600-4000 cGy over 20 fractions. Chemotherapy + Nodal RT vinblastine 3 cycles (28 days each) of chemotherapy (doxorubicin 25 mg/m\^2 on days 1 and 15, vinblastine 6 mg/m\^2 on days 1 and 15). Four weeks after last cycle, subtotal nodal irradiation (total dose 3600-4000 cGy over 20 fractions) will be given as described for the Nodal RT arm.
- Primary Outcome Measures
Name Time Method overall survival every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter progression-free survival every 3 months while on protocol treatment, then every 6 months for 2 years, then annually thereafter
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Scroll for more (12 remaining)University of California San Diego Cancer Center🇺🇸La Jolla, California, United States