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NSABP Clinical Trials Overview


Protocol R-02
A Protocol to Compare Adjuvant MeCCNU, Vincristine and 5-Fluorouracil (MOF), With and Without Radiation, to Adjuvant Leucovorin and 5-Fluorouracil (LV+5FU), With and Without Radiation, in Patients with Dukes' B and C Carcinoma of the Rectum

Specific Aims
Protocol R-02 has been designed to determine if the addition of radiation therapy to chemotherapy improves disease-free survival and survival in patients with Dukes' B and C carcinoma of the rectum. Based on findings in Protocol R-01, males are randomized to one of four treatment regimens: MOF, MOF+RT, LV+5FU, or LV+5FU+RT; females are randomized to one of two treatment regimens: LV+5FU or LV+5FU+RT. Specific aims are: (1) to determine whether radiation, when added to a chemotherapeutic regimen, prolongs disease-free survival and survival; (2) for males only, to compare MOF, with and without radiation, to LV+5FU, with and without radiation; and (3) for males and females, to compare LV+5FU without radiation to LV+5FU with radiation.