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NSABP Clinical Trials Overview

Protocol C-04
A Clinical Trial to Assess the Relative Efficacy of 5-FU + Leucovorin, 5-FU + Levamisole, and 5-FU + Leucovorin + Levamisole in Patients with Dukes' B and C Carcinoma of the Colon

Specific Aims
In patients who have undergone a "curative" resection of a Dukes' B or C carcinoma of the colon, to determine if the addition of levamisole to leucovorin-modulated 5-FU provides an additional benefit in regard to disease-free survival and survival and, if so, to assess whether this benefit is superior to that achieved by administration of 5-FU + levamisole. The study will also evaluate whether 5-FU administered with levamisole is superior to leucovorin-modulated 5-FU.