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.

International Journal of Radiation Oncology, Biology, Physics
David I RosenthalAl B Benson

Abstract

Oxaliplatin is a platinum analog and radiosensitizer active in colorectal cancer. We performed a Phase I trial to test the safety and preliminary efficacy of adding oxaliplatin to standard preoperative chemoradiation therapy for rectal cancer. Eligible patients had T3 to T4 rectal adenocarcinoma. Patients received standard-dose radiation (50.4 Gy for 5.5 weeks) with concurrent infused 5-fluorouracil (5-FU) at 200 mg/m2 per day, 7 days per week. Oxaliplatin was given three times at 14-day intervals at 55, 70, or 85 mg/m2 during the 5.5-week radiation period, before resection. Adjuvant therapy consisted of four cycles of 5-FU (500 mg/m2 per week) with leucovorin (500 mg/m2 per week) given every 6 weeks. The main goals were to identify the maximum tolerated dose of oxaliplatin and the dose-limiting toxicities when given with 5-FU and RT. Secondary goals were to determine resectability, pathologic response, sphincter preservation, and overall survival rates. Twenty-one patients were enrolled, 5 at the 55 mg/m2 oxaliplatin dose level, 5 at 70 mg/m2, and 11 at 85 mg/m2. All patients were able to complete the preoperative chemoradiation regimen with no dose adjustments. No dose-limiting toxicities or differences in the type or extent ...Continue Reading

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Citations

Nov 26, 2010·International Journal of Colorectal Disease·Francesco DionisiEnzo Banelli
Dec 9, 2010·Journal of Gastrointestinal Surgery : Official Journal of the Society for Surgery of the Alimentary Tract·Luiz Felipe de Campos-LobatoMatthew F Kalady
Jul 1, 2006·Biomedical Imaging and Intervention Journal·R MurthyR Salem
Jan 1, 2016·Clinical Oncology : a Journal of the Royal College of Radiologists·T A GreenhalghR A Sharma
May 26, 2009·International Journal of Radiation Oncology, Biology, Physics·Christopher H CraneMiguel A Rodriguez-Bigas
Jun 15, 2014·International Journal of Radiation Oncology, Biology, Physics·Takatoshi NakamuraMasahiko Watanabe
Oct 13, 2018·The British Journal of Surgery·R CliffordD Vimalachandran
Apr 12, 2019·EJNMMI Research·Thititip TippayamontriLéon Sanche
Oct 29, 2019·Physics in Medicine and Biology·Ikechi OzoemelamPeter Dendooven
Mar 5, 2019·Metabolomics : Official Journal of the Metabolomic Society·Kai YangZheng-Jiang Zhu
Jan 13, 2011·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Kate H Brettingham-MooreWayne A Phillips

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