A randomized multicenter trial was started to evaluate the effect of irradiation combined with 5-fluorouracil and methotrexate on survival after surgery for rectal and rectosigmoidal carcinoma, Dukes' stages B and C. The trial was terminated prematurely after entrance of 34 patients due to frequent and serious complications. Three patients died as a direct consequence of the adjuvant treatment.
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Sparsø et al. (1984) studied this question.
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