S0820, Adenoma and Second Primary Prevention Trial (NCT01349881) | Clinical Trial Compass
Active — Not RecruitingPhase 3
S0820, Adenoma and Second Primary Prevention Trial
United States354 participantsStarted 2013-08-23
Plain-language summary
The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon or rectal cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* History of Stage 0-III colon or rectal cancer with primary resection 1 year previously
* Post-operative colonoscopy and CT scans of chest, abdomen \& pelvis showing no evidence of disease
* Must not have cardiovascular risk factors including unstable angina, history of myocardial infarction, or cerebrovascular accident, coronary artery bypass surgery, or NY Heart Assoc Class III or IV heart failure.
* Patients must not have known uncontrolled hyperlipidemia (defined as LDL-C \>/= 190 mg/dL or triglycerides \>/= 500 mg/dL within the past 3 years or uncontrolled high blood pressure (systolic blood pressure \> 150 mm Hg) within 28 days prior to registration
* At least 30 days from completion of adjuvant chemo and RT.
* Presence of gastroesophageal reflux disease acceptable if controlled with medications
* Not receiving or planning to receive concomitant intravenous corticosteroids on a regular basis,nonsteroidal anti-inflammatory drugs (NSAIDs), nor anticoagulants on a regular predictable intermittent basis. NSAID use must not exceed 10 days per month; Maximum aspirin dose
* 100 mg per day or ≤ two 325 mg tablets per week. Inhaled steroids (i.e. for asthma or related conditions) are allowed.
* Able to swallow oral medications
* Laboratory: WBC ≥ 4.0 x 1000/mcL, platelets ≥ 100,000/mcL and hemoglobin \> 11.0 g/dL. (A total WBC ≥ 3.1 x 1000/mcL is allowed for non-Hispanic black males and total WBC ≥ 3.4 x 1000/mcL for non-Hispanic black females. Serum bil…
What they're measuring
1
Event rate, defined as rate of high-risk adenoma or second primary colorectal cancer (CRC)