A PHASE II TRIAL OF EIGHT-WEEK STANFORD V CHEMOTHERAPY PLUS MODIFIED INVOLVED FIELD RADIOTHERAPY IN FAVORABLE, LIMITED STAGE HODGKIN'S DISEASE

Trial Information

A PHASE II TRIAL OF EIGHT-WEEK STANFORD V CHEMOTHERAPY PLUS MODIFIED INVOLVED FIELD RADIOTHERAPY IN FAVORABLE, LIMITED STAGE HODGKIN'S DISEASE

OBJECTIVES: I. Determine the progression-free and overall survival at 5 and 10 years after a
short-term Stanford V regimen comprising mechlorethamine, doxorubicin, vinblastine,
prednisone, vincristine, bleomycin, and etoposide followed by modified involved-field
radiotherapy in patients with favorable, early-stage Hodgkin's disease. II. Determine
whether the early and late toxic effects of treatment can be minimized by avoiding staging
laparotomy, limiting cumulative doses of chemotherapeutic drugs, and reducing the dose and
volume of radiotherapy in these patients. III. Determine the freedom from second disease
progression at 5 and 10 years after treatment and treatment-related toxicity in these
patients. IV. Determine the quality of life of patients treated with this regimen.

OUTLINE: Patients receive the Stanford V regimen comprising mechlorethamine IV on days 1 and
29; doxorubicin IV and vinblastine IV on days 1, 15, 29, and 43; oral prednisone every other
day on days 1-36 followed by tapered doses; vincristine IV and bleomycin IV on days 8, 22,
36, and 50; and etoposide IV on days 15, 16, 43, and 44. Beginning 2 weeks after completion
of chemotherapy and when blood counts recover, patients undergo modified involved-field
radiotherapy 5 days a week for 3-4 weeks. Quality of life is assessed. Patients are followed
every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 5 years.