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Celecoxib with Chemoradiation for Rectal Cancer
NCT00336960Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2002
- Primary completion
- Nov 2004
- Countries
- 1
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Modality
- Orthosteric Ligands
- Drugs
- celecoxib
- Conditions
- rectal cancer
01
Overview
Phase 2, open-label, single-arm trial of celecoxib in rectal cancer, sponsored by Vanderbilt-Ingram Cancer Center. Primary endpoint: Pathologic Complete Response Rate. Started Jul 2002; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
treatment intervention
Celecoxib + 5FU + RT followed by Surgery
03
Who it enrols
Patients with histologically confirmed stage II or III adenocarcinoma of the rectum, resectable tumor, no prior pelvic radiotherapy, and adequate organ function.
04
Endpoints
Primary
Pathologic Complete Response Rate
Secondary
Complete Resection Rate
Patterns of Failure
Survival
Toxicity
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