A Phase II Trial of Celecoxib With Preoperative Chemo- Radiation for Locally Advanced Rectal Cancer
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
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
10 weeks
Yes
Lin Wei Wang, MD
Principal Investigator
National Health Research of Institutes, Taiwan Cooperative Oncology Group
Taiwan: Department of Health
T2207
NCT00931203
July 2008
July 2010
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