NCT00931203

Trial of Celecoxib With Preoperative Chemo- Radiation for Locally Advanced Rectal Cancer

A Phase II Trial of Celecoxib With Preoperative Chemo- Radiation for Locally Advanced Rectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: National Health Research Institutes, Taiwan · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm phase II trial with combined celecoxib, tegafur-uracil, folinate and preoperative radiotherapy for patients with locally advanced rectal cancer. The primary end point is pathological complete response (pCR) rate. The secondary endpoints are toxicities of combined celecoxib and chemoradiation, negative resection margin rate, clinical tumor response by magnetic resonance imaging (MRI), sphincter preservation rate, disease-free survival and overall survival.

Detailed description

The primary objective is to determine the pathological complete response (pCR) of combining preoperative tegafur-uracil, folinate, radiation and celecoxib for locally advanced rectal cancer. The secondary objectives of this study are to determine: 1. Toxicity profile of combining celecoxib, tegafur-uracil, folinate and preoperative radiation for locally advanced rectal cancer. 2. Negative resection margins (circumferential resection margin) rate. 3. Downstaging rate. 4. Sphincter preservation rate 5. Locoregional and distant failure rate. 6. Overall survival

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
DRUG	Celecoxib	Celecoxib (400 mg/d) will be continued from day 1 to 65

Timeline

• Start date: 2008-07-01
• Primary completion: 2012-06-01
• Completion: 2013-04-01
• First posted: 2009-07-02
• Last updated: 2016-05-04

Locations

1 site across 1 country: Taiwan