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The initial aim of the present study was to verify in a randomized trial whether the addition of Levamisole, an immunomodulator, could increase the effectiveness of postoperative chemotherapy (MeCCNU + 5-FU) in Dukes C colorectal cancer patients. After entering 29 consecutive patients, the poor results of most studies of adjuvant therapy in colorectal cancer prompted an early end to patient accrual. After 8 years, the lack of significance in survival (48.9 versus 37.3%) and disease-free survival (50 versus 38.8%) between the two treatment arms rules out any improvement associated with Levamisole administration.
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