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

Locally Advanced Rectal Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

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 NCT00931203
Study type Interventional
Source National Health Research Institutes, Taiwan
Contact
Status Completed
Phase Phase 2
Start date July 2008
Completion date April 2013
View Details
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