Status:
COMPLETED
Trial of Celecoxib With Preoperative Chemo- Radiation for Locally Advanced Rectal Cancer
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
Taipei Veterans General Hospital, Taiwan
Changhua Christian Hospital
Conditions:
Locally Advanced Rectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 pathologi...
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 seco...
Eligibility Criteria
Inclusion
- Patients with resectable or potentially resectable adenocarcinoma of the rectum.
- Clinical stage by Magnetic Resonance Image (MRI) of pelvis, ultrasonography of liver and Chest X ray: AJCC T2 N1-2M0 or T3-4 N0-2M0 (patients who require diverting loop colostomy are eligible). Nuclear medicine study (whole body bone scan or PET scan) can be performed if clinically indicated.
- Bi-dimensionally measurable disease by MRI, which can be done with pelvic array coil and intrarectal tube.
- Age greater than 18 years and \< 80 years, ECOG performance status \< 2
- Biopsy proven adenocarcinoma, superior margin of the tumor below the L5-S1 spine junction.
- WBC \> 3.5 x109/L, neutrophil count \> 1.5x109/L, platelet count \> 100x109/L, serum bilirubin \< 1.25xULN (upper limit of normal), AST/ALT \< 3x ULN, serum creatinine \< 1.25xULN.
- Informed consent signed.
Exclusion
- Distant metastasis, Prior pelvic irradiation, Inflammatory bowel disease, Medical conditions which preclude radical therapy.
- History of malignancy within five years (except nonmelanoma skin cancer, CIN cervix).
- Pregnancy.
- Hypersensitivity to celecoxib, NSAID, sulfonamides or 5-FU.
- Cardiovascular disease like congestive heart failure, symptomatic coronary artery disease, or myocardiac infarction.
- History of peptic ulcer disease or NSAID-related gastrointestinal bleeding
- Use of aspirin, other NSAID or celecoxib in the two weeks prior to study entry.
- Patients taking warfarin or other anticoagulating medicine.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00931203
Start Date
July 1 2008
End Date
April 1 2013
Last Update
May 4 2016
Active Locations (1)
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1
Mackay Memorial Hospital
Taipei, Taiwan