NCT02277158

Phase I Study of CCRT as Adjuvant Treatment for Stage II/III Operable Rectal Cancer.

A Phase I Study of Concurrent Radiotherapy and Tegafur, Gimeracil and Oteracil Potassium Capsule(S-1) as Adjuvant Treatment for Stage II/III Operable Rectal Cancer.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the maximum tolerated dose and safety of S-1 plus radiotherapy for patients with rectal cancer

Detailed description

This stage I study is designed to evaluate the appropriate dose of S-1 plus radiotherapy for patients with R0 resection of rectal cancer for stage II-III patients(AJCC 7th). To evaluate safety, data on adverse events will be collected from the time of enrollment until withdrawn of complete whole study.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Chemoradiotherapy	S-1 CCRT

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-06-01
• Completion: 2015-12-01
• First posted: 2014-10-28
• Last updated: 2014-12-02

Locations

1 site across 1 country: China