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 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT00608595
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of primary adenocarcinoma of the rectum (to be histologically confirmed upon study entry)
* Tumor must be at or below the peritoneal reflection
* The distal border of the tumor is within 12 cm of the anal verge on proctoscopic examination
* Clinically resectable 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 (other than rectal cancer) that would preclude study therapy
* No psychiatric condition that would preclude informed consent
* No history of allergy to celecoxib or any other NSAIDs, including acetylsalicylic acid (i.e., aspirin), ibuprofen, or indomethacin
* No history of allergy to sulfonamides
Exclusion criteria:
Not noted
PRIOR CONCURRENT THERAPY:
* At least 7 days since prior and no concurrent NSAIDs or other cyclooxygenase-2 inhibitors
* No concurrent warfarin, except low-dose warfarin (i.e., 1 mg/day) administered for prophylaxis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00608595
Study Brief:
Protocol Section:
NCT00608595