Phase II study of neoadjuvant concurrent chemioradiotherapy with oxaliplatin-containing regimen in locally advanced rectal cancer.

UNLABELLED: The purpose of this phase II trial was to assess tolerance and efficacy of the combination of radiation, fluorouracil and oxaliplatin as neoadjuvant treatment in locally advanced rectal cancer. Between March 2001 and August 2004 , 28 patients M/18 F/10 with locally advanced rectal cancer were entered in our study. All the patients underwent to the Radiotherapy with a total dose was 45 Gy and concurrent chemotherapy with Oxaliplatin 80 mg/mq G1 on weeks 1,3,5 followed by five day continuous infusion of 5-Fluorouracile 300 mg/mq on five consecutive weeks. Surgery was planned 5 weeks later. Surgery was performed in all patients after a mean interval time of 5 weeks. Side effects and toxicity included grade II sec WHO diarrhea and grade II mucositis , grade I-II dysuria and skin reaction Downstaging to T0-2N0 was achieved in 18 patients (65%) with 4 (15%) achieving a pathologically complete response. CONCLUSIONS: Such a combined preoperative chemioradiotherapy and oxaliplatin-containing regimen is well tolerated with non increase in surgical toxicity. The good response rate observed warrants its use in further clinical trials.