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 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT00087256
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the colon
* Stage I disease
* Distal border of tumor ≥ 12 cm from the anal verge
* Tumor completely resected within the past 90 days
* Must have undergone a preoperative or postoperative colonoscopy to the cecum (or small bowel anastomosis) within the past 90 days
* All observed polyps must have been removed
* Patients with a history suggestive of hereditary non-polyposis colorectal cancer (HNPCC) must have a normal microsatellite instability status by immunohistochemistry or polymerase chain reaction
* Patients with family history of colon cancer who have not been diagnosed with HNPCC are eligible
* No prior familial adenomatous polyposis
* No prior invasive cancer or carcinoma in situ of the colon or rectum
* No clinical or radiologic evidence of metastatic disease
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-1
Life expectancy
* At least 10 years
Hematopoietic
* Complete blood count normal
* Platelet count normal
Hepatic
* Aspartate aminotransferase (AST) normal
* Bilirubin normal
* Alkaline phosphatase normal
Renal
* Creatinine normal
Cardiovascular
* No active ischemic heart disease
* No New York Heart Association class III or IV heart disease
* No myocardial infarction within the past 6 months
* No symptomatic arrhythmia
* No symptomatic peripheral vascular disease or carotid disease that would preclude study participation
Pulmonary
* No aspirin-sensitive asthma
Gastrointestinal
* No history of inflammatory bowel disease
* No history of upper gastrointestinal bleeding
* No history of duodenal or gastric ulcer
Other
* No known hypersensitivity to any COX-2 inhibitor, NSAIDs, aspirin, or sulfonamides
* No non-colorectal malignancy within the past 5 years except carcinoma in situ of the cervix, melanoma in situ, or basal cell or squamous cell skin cancer
* No other disease that would preclude study participation
* No psychiatric disorders, including history of clinical depression or addictive disorders, that would preclude giving informed consent or long-term compliance
* No rheumatologic or skeletal disorders requiring chronic NSAIDs or steroid therapy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
Other
* No other concurrent investigational agents for colon cancer
* No concurrent chronic use of other cyclo-oxygenase-2 (COX-2) inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs), or salicylates (e.g., aspirin)
* Chronic use is defined as use for more than an average of 3 days per month
* Concurrent NSAIDs allowed for up to 10 consecutive days for temporary relief due to inflammatory syndromes, injury, or postoperative pain
* Cardioprotective doses of aspirin (≤ 81 mg/day or 325 mg every other day) allowed
* No concurrent fluconazole or lithium
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00087256
Study Brief:
Protocol Section:
NCT00087256