Locally Advanced Rectal Cancer
Conditions
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 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.
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 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
Interventions
DRUGCelecoxib
Celecoxib (400 mg/d) will be continued from day 1 to 65
Sponsors
Taipei Veterans General Hospital, Taiwan
Changhua Christian Hospital
Chi Mei Medical Hospital
Taichung Veterans General Hospital
National Cheng-Kung University Hospital
Chang Gung Memorial Hospital
Mackay Memorial Hospital
National Health Research Institutes, Taiwan
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with resectable or potentially resectable adenocarcinoma of the rectum. 2. 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. 3. Bi-dimensionally measurable disease by MRI, which can be done with pelvic array coil and intrarectal tube. 4. Age greater than 18 years and \< 80 years, ECOG performance status \< 2 5. Biopsy proven adenocarcinoma, superior margin of the tumor below the L5-S1 spine junction. 6. 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. 7. Informed consent signed.
Exclusion criteria
1. Distant metastasis, Prior pelvic irradiation, Inflammatory bowel disease, Medical conditions which preclude radical therapy. 2. History of malignancy within five years (except nonmelanoma skin cancer, CIN cervix). 3. Pregnancy. 4. Hypersensitivity to celecoxib, NSAID, sulfonamides or 5-FU. 5. Cardiovascular disease like congestive heart failure, symptomatic coronary artery disease, or myocardiac infarction. 6. History of peptic ulcer disease or NSAID-related gastrointestinal bleeding 7. Use of aspirin, other NSAID or celecoxib in the two weeks prior to study entry. 8. Patients taking warfarin or other anticoagulating medicine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 1.Toxicity profile of combining celecoxib, tegafur-uracil, folinate and preoperative radiation for locally advanced rectal cancer. | > 28 weeks |
| Negative resection margins (circumferential resection margin) rate. | > 28 weeks |
| Downstaging rate. | > 28 weeks |
| Sphincter preservation rate. | > 28 weeks |
Countries
Taiwan
Outcome results
None listed