Acetylsalicylic Acid Compared to Placebo in Treating High-Risk Patients With Subsolid Lung Nodules
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|ClinicalTrials.gov Identifier: NCT02169271|
Recruitment Status : Active, not recruiting
First Posted : June 23, 2014
Last Update Posted : January 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Current Smoker Former Smoker Multiple Pulmonary Nodules Tobacco Use Disorder||Drug: Aspirin Other: Laboratory Biomarker Analysis Other: Placebo||Phase 2|
I. The evaluation of the effect of aspirin (acetylsalicylic acid) as a chemopreventive agent for lung cancer.
I. The modulation of biological markers after treatment and the correlation of these findings with modification of lung nodules diameters.
II. The per-lesion analysis including the 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 Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive acetylsalicylic acid orally (PO) once daily (QD) for 12 months.
ARM II: Patients receive placebo PO QD for 12 months.
After completion of study treatment, patients are followed up for 1 month.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized Phase II Trial of Low Dose Aspirin Versus Placebo in High-Risk Individuals With CT-Detected Subsolid Lung Nodules|
|Actual Study Start Date :||November 21, 2014|
|Actual Primary Completion Date :||July 13, 2018|
Experimental: Arm I (acetylsalicylic acid)
Patients receive acetylsalicylic acid PO QD for 12 months.
Other: Laboratory Biomarker Analysis
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO QD for 12 months.
Other: Laboratory Biomarker Analysis
- Difference in sum of longest diameters of baseline target lesions in a person-specific analysis [ Time Frame: Baseline to 1 year ]Target lesions will be defined as non-solid or partially solid nodules. New lesions identified during follow-up satisfying the same criteria for the definition of target lesion will also be included in the analysis. A two-sided paired t-test will be used to compare the average change in the dimension of sub-solid nodules in the aspirin group compared to the placebo group.
- Evaluation of response according to modified RECIST criteria [ Time Frame: Up to 1 year ]The per-lesion analysis and per-subject analysis will be done according to modified RECIST criteria. In case of multiple lesions, treatment will be considered successful when a complete response or partial response occurs according to modified RECIST criteria, while treatment will be considered a failure when progression of disease or stable disease occurs according to the same criteria.
- Change in the number and size of non target lesions [ Time Frame: Baseline to 1 year ]All tests will be two-sided and considered significant at the 5% level.
- Nodule density measured by quantitative changes in mean and maximum Hounsfields Unit [ Time Frame: Baseline to 1 year ]All tests will be two-sided and considered significant at the 5% level.
- Sensitivity of micro ribonucleic acid (miRNA) to identify patients with ground glass opacities (GGO) or with partially solid nodules and predict aspirin treatment response [ Time Frame: Up to 1 year ]All tests will be two-sided and considered significant at the 5% level.
- Specificity of miRNA to identify patients with GGO or with partially solid nodules and predict aspirin treatment response [ Time Frame: Up to 1 year ]All tests will be two-sided and considered significant at the 5% level.
- Accuracy of miRNA to identify patients with GGO or with partially solid nodules and predict aspirin treatment response [ Time Frame: Up to 1 year ]All tests will be two-sided and considered significant at the 5% level.
- Biomarker analysis [ Time Frame: Up to 1 year ]Will include the modulation of high sensitivity-C-reactive protein (hs-CRP) as marker of inflammation, 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 metabolite (PGEM) and leukotriene E4 (LTE4) normalized to urinary creatinine concentration. Serum thromboxane B2 (TXB2) will be determined as a measure of compliance. Results will be compared between the two treatment arms (aspirin and placebo).
- Tolerability, defined by the incidence of adverse events graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 13 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169271
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|European Institute of Oncology|
|Milano, Italy, 20141|
|Principal Investigator:||Bernardo Bonanni||M.D. Anderson Cancer Center|