A phase II open-label prospective study of preoperative chemoradiation with oxaliplatin/5FU in locally advanced rectal cancer followed by total mesorectal excision and adjuvant FOLFOX6.

e14128 Background: 5FU based neoadjuvant chemoradiation (nCRT) is the standard of care for stage II/III rectal cancer. Pathologic complete response (pCR) and downstaging have been associated with improved outcomes. The addition of oxaliplatin (OXA) to neoadjuvant therapy may reduce distant disease recurrence. Adjuvant treatment with OXA for rectal cancer has been motivated by benefits demonstrated in stage III colon cancer. Objective: To determine the feasibility, toxicity, and efficacy of preoperative OXA/5FU and RT followed by total mesorectal excision (TME) and adjuvant FOLFOX6. Methods: 27 patients with stage II/III rectal cancer were treated with OXA 60 mg/m2 weekly continuous infusion 5FU of 225 mg/m2/d d1-5 with pelvic RT of 1.8 Gy/d for 28 doses. Adjuvant therapy consisted of 6 cycles of biweekly FOLFOX6. Results: 92% and 93% of intended neoadjuvant OXA and 5FU doses were given. First 5 patients enrolled received weekly continuous 5FU d1-7, later subjects received 5FU d1-5 due to toxicity. After n...