drugset / Trial / NCT00931203
Trial of Celecoxib With Preoperative Chemo- Radiation for Locally Advanced Rectal Cancer
Phase 2
Completed
55 enrolled
National Health Research Institutes, Taiwan
Chang Gung Memorial Hospital · collabChanghua Christian Hospital · collabChi Mei Medical Hospital · collabMackay Memorial Hospital · collabNational Cheng-Kung University Hospital · collabTaichung Veterans General Hospital · collabTaipei Veterans General Hospital, Taiwan · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2008-07
- Primary completion
- 2012-06
- Completion
- 2013-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Celecoxib | Other / unclassified | 400 mg | — |
Indications
No indication recorded.