Complications following postoperative combined radiation and chemotherapy in adenocarcinoma of the rectum and rectosigmoid. A randomized trial that failed.
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.
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D011878:Radiotherapy / Q000009:adverse effects; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D012811:Sigmoid Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery
D005472:Fluorouracil; D008727:Methotrexate