This randomized phase II trial studies acetylsalicylic acid compared to placebo in treating high-risk patients with subsolid lung nodules. A nodule is a growth or lump that may be malignant (cancer) or benign (not cancer). Chemoprevention is the use of drugs to keep cancer from forming or coming back. The use of acetylsalicylic acid may keep cancer from forming in patients with subsolid lung nodules.
PRIMARY OBJECTIVES: I. The evaluation of the effect of aspirin (acetylsalicylic acid) as a chemopreventive agent for lung cancer. SECONDARY OBJECTIVES: 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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
109
M D Anderson Cancer Center
Houston, Texas, United States
European Institute of Oncology
Milan, Italy
Change in the Sum of Longest Diameters of Baseline Target Nodules (Person-specific Analysis)
Difference (12 month-baseline) in the sum of longest diameters of baseline target nodules.
Time frame: Twelve-month treatment
Change in the Sum of Baseline Target Nodules Diameters (Per Nodules Analysis)
Difference (12 month-baseline) in the sum of baseline target nodules diameters
Time frame: Baseline up to 1 year
Change in Lesion Volume
Difference (12 month-baseline) in lesion volume
Time frame: Baseline to 1 year
Change in Lesion Density
Difference (12 month-baseline) in lesion density
Time frame: Baseline up to 1 year
Modulation of Thromboxane B2
Difference (12 month-baseline) in biomarker concentration
Time frame: Baseline up to 1 year
Modulation of Prostaglandin E Metabolites (Normalized to Urinary Creatinine Concentration)
Difference (12 month-baseline) in biomarker concentration
Time frame: Baseline up to 1 year
Modulation of Leukotriene E4 (Normalized to Urinary Creatinine Concentration)
Difference (12 month-baseline) in biomarker concentration
Time frame: Baseline up to 1 year
Modulation of High Sensitive CRP
Difference (12 month-baseline) in biomarker concentration
Time frame: Baseline up to 1 year
Modulation of miRNA Prediction Risk Score
Difference (12 month-baseline) of the score on a scale (scale from -20 to +30 which measure the risk of lung cancer. Higher values indicate higher risk. A value\<0 is considered negative, a value ≥0 positive for lung cancer).
Time frame: Baseline up to 1 year
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