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Brief Title: Preoperative S-1/OHP With Radiation Therapy for Low-lying Rectal Carcinoma in Neo-adjuvant Setting
Official Title: A Phase I/II Study of S-1 and Oxaliplatin Combined With Radiation for Preoperative Locally Advanced Rectal Carcinoma. (SHOGUN Trial)
Study ID: NCT01227239
Brief Summary: The purpose of this study is to assess the safety and efficacy of S-1 and oxaliplatin combined with radiation by Phase I/II study. The purpose of this study is as follows, * In phase I, to determine the dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD). * In phase II, to evaluate the antitumor effect (pCR rate) and the safety .
Detailed Description:
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Nagoya University Graduate School of Medicine, Nagoya, , Japan
Osaka Medical College, Osaka, , Japan
Jichi Medical University Hospital, Tochigi, , Japan
Tokyo University, Tokyo, , Japan
Cancer Institute Hospital, Tokyo, , Japan
Teikyo University, Tokyo, , Japan
Name: Toshiaki Watanabe, M.D.
Affiliation: Tokyo University
Role: PRINCIPAL_INVESTIGATOR