NCT01227239

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Japan Clinical Cancer Research Organization · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• Rectal Carcinoma

Interventions

Type	Name	Description
DRUG	S-1	40mg/m2 orally twice a day (BID) for 5 days a week at 1st week, 2nd week, 4th week and 5th week.
DRUG	Oxaliplatin	40-60mg/m2/week intravenously on day 1, 8, 22 and 29.
RADIATION	Radiation	Total dose is 50.4Gy (1.8Gy X 28 fractions)

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-08-01
• Completion: 2016-08-01
• First posted: 2010-10-25
• Last updated: 2012-11-27

Locations

6 sites across 1 country: Japan