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:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT00336960
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed primary adenocarcinoma of the rectum
* Stage II or III disease
* Distal border of tumor must be at or below the peritoneal reflection
* Distal border of the tumor must be within 12 cm of the anal verge by proctoscopic exam
* Tumor must be clinically resectable
* Transmural penetration beyond muscularis propria by transrectal ultrasound
* No high-grade obstruction
* No evidence of metastatic disease
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* WBC ≥ 4,000/mm³
* Platelet count ≥ 150,000/mm³
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other serious medical illness or psychiatric condition that would preclude study treatment
* No history of allergy to celecoxib or any other NSAIDs
* No history of allergy to sulfonamides
* No prior or concurrent malignancy except inactive noninvasive cervical carcinoma or skin cancer (excluding melanoma) or other cancer that has been disease free for ≥ 5 years
PRIOR CONCURRENT THERAPY:
* No prior radiotherapy to the pelvis
* At least 7 days since prior and no other concurrent COX-2 inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs)
* No concurrent warfarin except low-dose warfarin (1 mg/day)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00336960
Study Brief:
Protocol Section:
NCT00336960