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subtotal nodal irradiation will consist of mantle and periaortic/spleen fields treated sequentially. Total dose 3600-4000 cGy over 20 fractions.

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.

doxorubicin hydrochloride

vinblastine

3600-4000 cGy delivered over 20 fractions

standard subtotal nodal irradiation

Oliver W. Press, MD, PhD

Todd H. Wasserman, MD

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.

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.

SWOG-9133 RT w/ or w/o Doxorubicin and Vinblastine in Stage I or Stage II Hodgkin's Disease

Randomized Trial of Subtotal Nodal Irradiation Versus Doxorubicin, Vinblastine and Subtotal Nodal Irradiation for Stage I-IIA Hodgkin's Disease

National Cancer Institute (NCI)

Cancer and Leukemia Group B

SWOG Cancer Research Network

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
SWOG-9133 RT w/ or w/o Doxorubicin and Vinblastine in Stage I or Stage II Hodgkin's Disease	NCT00002495	Lymphoma	doxorubicin hyd... vinblastine standard subtot...	16 Years -	SWOG Cancer Research Network
SWOG-9133 RT w/ or w/o Doxorubicin and Vinblastine in Stage I or Stage II Hodgkin's Disease	NCT00002495	Lymphoma	doxorubicin hyd... vinblastine standard subtot...	16 Years -	SWOG Cancer Research Network

Spots Global Cancer Trial Database for standard subtotal nodal irradiation