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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT00368927
Eligibility Criteria:
Inclusion Criteria:
* Current or former smoker who has smoked at least 30 pack years AND meets 1 of the following criteria:
* No prior lung cancer
* Prior stage I non-small cell lung cancer(NSCLC) that was completely resected ≥ 1 year ago OR for which patient completed adjuvant chemotherapy ≥ 1 year ago
* Tissue blocks, blood, and sputum samples available for research purposes
* No carcinoma in situ
* ECOG performance status 0-1
* Hemoglobin ≥ 12.0 g/dL (women) or hemoglobin ≥ 13.5 g/dL (men)
* WBC ≥ 3,000/mm³
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT ≤ 1.5 times ULN
* Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥30 mL/min
* Room air oxygen saturation ≥ 90%
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Negative chest x-ray
* Negative electrocardiogram
* No other cancer within the past 3 years except nonmelanoma skin cancer, localized prostate, carcinoma in situ of the cervix cancer, or superficial bladder cancer
* Treatment must have been completed \> 6 months ago
* No prior gastrointestinal ulceration, bleeding, or perforation
* No uncontrolled illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Myocardial infarction within the past 6 months
* Chronic renal disease
* Chronic liver disease
* Difficult to control hypertension
* Psychiatric illness or social situations that would limit study compliance
* No known HIV positivity
* No history of allergic reactions or hypersensitivity to sulindac or other NSAIDs, including aspirin-sensitive asthma or urticaria
* No known sensitivity to yellow dye FD\&C Yellow #5
* No continuous or intermittent supplemental oxygen
* At least 6 months since prior participation in another chemoprevention trial
* At least 6 months since prior regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids (may be eligible after washout period of 12 weeks for NSAIDs and 6 weeks for corticosteroids)
* No prior pneumonectomy
* No prior solid organ transplantation
* No other concurrent investigational agents
* No concurrent regular use of acetylsalicylic acid (aspirin) unless prescribed by a physician for prevention
* Maximum of 1 aspirin (81 mg) per day allowed
* No concurrent use of any of the following:
* Methotrexate
* Corticosteroids
* Antiplatelet agents:
* Warfarin
* Ticlopidine
* Clopidogrel bisulfate
* Aspirin
* Abciximab
* Dipyridamole
* Eptifibatide
* Tirofiban hydrochloride
* Lithium carbonate
* Cyclosporine
* Hydralazine
* Angiotensin-converting enzyme (ACE) inhibitors (ACE receptor antagonists are allowed)
* Angiotensin receptor blockers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
79 Years
Study:
NCT00368927
Study Brief:
Protocol Section:
NCT00368927