Phase I Study of Preoperative Radiation Therapy With Concurrent Infusional 5-Fluorouracil and Oxaliplatin Followed by Surgery and Postoperative 5-Fluorouracil Plus Leucovorin for T3/T4 Rectal Adenocarcinoma: ECOG E1297

摘要: Purpose Oxaliplatin is a platinum analog and radiosensitizer active in colorectal cancer. We performed Phase I trial to test the safety preliminary efficacy of adding oxaliplatin standard preoperative chemoradiation therapy for rectal Methods Materials Eligible patients had T3 T4 adenocarcinoma. Patients received standard-dose radiation (50.4 Gy 5.5 weeks) with concurrent infused 5-fluorouracil (5-FU) at 200 mg/m 2 per day, 7 days week. was given three times 14-day intervals 55, 70, or 85 during 5.5-week period, before resection. Adjuvant consisted four cycles 5-FU (500 week) leucovorin every 6 weeks. The main goals were identify maximum tolerated dose dose-limiting toxicities when RT. Secondary determine resectability, pathologic response, sphincter preservation, overall survival rates. Results Twenty-one enrolled, 5 55 level, 70 , 11 . All able complete regimen no adjustments. No differences type extent toxicity noted among groups. Nineteen underwent surgery (three abdominopelvic resections 16 low anterior resections), an 84% preservation rate. response rate 26% (5 patients), minimal microscopic residual tumor found 21% (4 additional patients). Conclusions well weeks combination rates major are promising.