A Randomized Phase II Trial of Low Dose Aspirin versus Placebo in High-Risk Individuals with CT-Detected Subsolid Lung Nodules, V14, A7, Dated 3/13/2017
Therese B. Bevers
The purpose of this study is to compare the safety and effects of low dose aspirin (100 mg/day ) with placebo on subjects with subsolid nodules. Currently no effective drug to prevent lung cancer in people at increased risk has been discovered. In your case these nodules are probably not cancerous but it is not possible to exclude that they may become cancers, so they should be monitored with periodic exams to evaluate their growth rate. At the moment the growth of your nodules does not have clinical relevance, but requires a yearly follow up with low dose CT scan. Previous studies have shown total NSAID use was associated with a small reduction in risk of lung cancer, which was strongest for adenocarcinoma in men, and in long-term former smokers and of a protective effect of lowdose aspirin was seen in the Women’s Health Study. Another study found that lung cancer risk was significantly lower for aspirin users compared to non-users and prolonged duration of use was associated with reduced lung cancer risk. We will also be studying the effect of Aspirin on levels of several different substances, called biomarkers, in your blood and urine. These biomarkers may be used to track the amount of lung tissue inflammation and the risk of developing lung cancer. In this study, you will get either aspirin 100mg/day or placebo, a pill that looks like the study drug but contains no medication. There will be 128 subjects taking part in this study. This is a randomized study. You will be randomly assigned to get a dose of aspirin or placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. Neither you or your doctor will know whether you are getting aspirin or placebo.
Treatment Location: N/A
1.1 Primary Objectives – The primary objective is the evaluation of the effect of Aspirin as a chemopreventive agent for lung cancer. Particularly, the efficacy of Aspirin in reduction of size and number of CT-detected lung subsolid nodules will be evaluated in high-risk asymptomatic subjects currently undergoing CT screening programs at the European Institute of Oncology (EIO) and at MD Anderson Cancer Center (MDACC). In addition, we will include subjects undergoing CT outside the context of a screening program with a subsolid nodule confirmed by a pulmonary CT scan (qualifying scan). The efficacy will be evaluated in a person-specific analysis. 1.2 Secondary Objectives – Secondary objective of the study will be the modulation of biological markers after treatment and the correlation of these findings with modification of lung nodules diameters. In particular we will evaluate the effect of Aspirin on a signature of serum microRNA correlated to subsolid nodules. Other secondary endpoints will be the per-lesion analysis including evaluation of lung nodule density before and after treatment, the number and size of non target lesions including solid nodules and evaluation of response according to modified RECIST criteria. Additional biomarkers will include the modulation of ultrasensitive circulating hs-CRP, the evaluation of urinary cotinine as marker of tobacco exposure and investigation of the potential effect of aspirin according to its concentration, the measurement of urinary prostaglandin metabolites (PGEM) and leukotriene (LTE4), both normalized normalized to urinary creatinine concentration. Serum concentration of thromboxane B2 (TXB2) will be determined as a measure of compliance.We will also evaluate the tolerability of Aspirin at dose of 100 mg/day.
IRB Review and Approval Date: 11/21/2014
Recruitment Status: Closed
Projected Accrual: N/A
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Therese B. Bevers
Clinical Cancer Prevention
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