Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT00931203
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00931203
Study Brief:
Protocol Section:
NCT00931203