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Preoperative S-1/OHP With Radiation Therapy for Low-lying Rectal Carcinoma in Neo-adjuvant Setting

Rectal Carcinoma Clinical Trial

Official title:
A Phase I/II Study of S-1 and Oxaliplatin Combined With Radiation for Preoperative Locally Advanced Rectal Carcinoma. (SHOGUN Trial)

Clinical Trial 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 .

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01227239
Study type Interventional
Source Japan Clinical Cancer Research Organization
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date September 2010
Completion date August 2016
View Details
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