- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02169271
Acetylsalicylic Acid Compared to Placebo in Treating High-Risk Patients With Subsolid Lung Nodules
A Randomized Phase II Trial of Low Dose Aspirin Versus Placebo in High-Risk Individuals With CT-Detected Subsolid Lung Nodules
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Milano, Italy, 20141
- European Institute of Oncology
-
-
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Asymptomatic current or former smokers (having stopped within the last 20 years)
- Smoking history >= 20 pack/years; subjects must be included in an ongoing annual screening with low dose CT scan or must have two consecutive CT outside the context of a screening program confirming subsolid nodules
- Subjects must have subsolid (non solid or partially solid) nodules with size between 4 and 10 mm with any volume doubling time (VDT) not candidate to surgical excision and/or subsolid (non solid or partially solid) nodule larger than 10 mm with VDT higher than 400 days and not candidate to surgical excision
- All nodules should be persistent at least after three months follow up with 1 dimension (1d)-CT; a reduction up to 15% of the diameter of the largest target nodule from the previous CT scan is allowed
- All current smokers should accept to receive support for smoking cessation
- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
- Leukocytes >= 3,000/microliter
- Absolute neutrophil count >= 1,500/microliter
- Platelets >= 100,000/microliter
- Total bilirubin =< 2 x institutional upper limit of normal (ULN) and/or history of Gilbert's syndrome
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x institutional ULN
- Serum creatinine =< institutional ULN
- Women of child-bearing potential (from first menstruation to 1 year after last menstruation) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
- Ability to understand and the willingness to sign a written informed consent document
- Signed informed consent
Exclusion Criteria:
- Subjects with chronic treatment (at least twice/week for more than 3 months) with aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
- History of allergic reactions attributed to compounds of similar chemical or biological composition to aspirin, NSAIDs, cyclooxygenase-2 (COX2) inhibitors
- Invasive malignancy (with the exclusion of basal cell carcinoma or skin squamous cell carcinoma) diagnosed during the last 2 years before randomization; stage I-II invasive malignancies that were diagnosed more than 2 years prior to randomization and have been treated curatively are allowed as long as all treatment is finished at least 18 months prior to randomization
- History of therapeutic doses of anticoagulants including warfarin and low molecular weight heparin (e.g. for prior deep venous thrombosis and pulmonary embolisms) in the preceding year
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with aspirin
- Individual may not be receiving any other investigational agents, antiplatelet agents (e.g. aspirin, clopidogrel [Plavix or others]), anticoagulants (e.g. heparin or heparinoids, Coumadin, or others), methotrexate, lithium
- Participants with bleeding diathesis, history of gastric/duodenal ulcers in the last 5 years, NSAID-precipitated bronchospasm, patients unwilling or unable to limit alcohol consumption to i.e. =< 3 alcohol drinks a day
- Participants who in the opinion of the principal investigator (PI) will be at higher risk of acetylsalicylic acid (ASA)-related complications
- Participants with known inability to adequately absorb oral medication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (acetylsalicylic acid)
Patients receive acetylsalicylic acid PO QD for 12 months.
|
Correlative studies
Given PO
Other Names:
|
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO QD for 12 months.
|
Correlative studies
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Sum of Longest Diameters of Baseline Target Nodules (Person-specific Analysis)
Time Frame: Twelve-month treatment
|
Difference (12 month-baseline) in the sum of longest diameters of baseline target nodules.
|
Twelve-month treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Sum of Baseline Target Nodules Diameters (Per Nodules Analysis)
Time Frame: Baseline up to 1 year
|
Difference (12 month-baseline) in the sum of baseline target nodules diameters
|
Baseline up to 1 year
|
Change in Lesion Volume
Time Frame: Baseline to 1 year
|
Difference (12 month-baseline) in lesion volume
|
Baseline to 1 year
|
Change in Lesion Density
Time Frame: Baseline up to 1 year
|
Difference (12 month-baseline) in lesion density
|
Baseline up to 1 year
|
Modulation of Thromboxane B2
Time Frame: Baseline up to 1 year
|
Difference (12 month-baseline) in biomarker concentration
|
Baseline up to 1 year
|
Modulation of Prostaglandin E Metabolites (Normalized to Urinary Creatinine Concentration)
Time Frame: Baseline up to 1 year
|
Difference (12 month-baseline) in biomarker concentration
|
Baseline up to 1 year
|
Modulation of Leukotriene E4 (Normalized to Urinary Creatinine Concentration)
Time Frame: Baseline up to 1 year
|
Difference (12 month-baseline) in biomarker concentration
|
Baseline up to 1 year
|
Modulation of High Sensitive CRP
Time Frame: Baseline up to 1 year
|
Difference (12 month-baseline) in biomarker concentration
|
Baseline up to 1 year
|
Modulation of miRNA Prediction Risk Score
Time Frame: Baseline up to 1 year
|
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).
|
Baseline up to 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Multiple Pulmonary Nodules
- Tobacco Use Disorder
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- NCI-2014-01311 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- P30CA016672 (U.S. NIH Grant/Contract)
- IEO-833/13F
- HHSN261201200034I
- EIO 833/13F
- 2013-004862-32
- TO-RFP A
- N01-CN-2012-00034 (CTRP (Clinical Trial Reporting Program))
- IEO 833/13F (IEO37)
- MDACC: 2013-0732
- IEO 37
- 2013-0732 (Other Identifier: M D Anderson Cancer Center)
- MDA2013-01-01 (Other Identifier: DCP)
- N01CN00034 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Current Smoker
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)WithdrawnCurrent Smoker | Malignant Neoplasm | Current Every Day Smoker | Cigarette SmokerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedCurrent Every Day Smoker | Cigarette SmokerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedCurrent Every Day Smoker | Cigarette SmokerUnited States
-
Roswell Park Cancer InstituteNational Institute on Drug Abuse (NIDA); National Cancer Institute (NCI)CompletedCurrent Smoker | Healthy Subject | Cigarette SmokerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedCurrent Smoker | Cigarette Smoker | Currently Living With SmokerUnited States
-
Ohio State University Comprehensive Cancer CenterNational Institute on Drug Abuse (NIDA)RecruitingCurrent Every Day Smoker | Cigarette SmokerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedCurrent Every Day Smoker | Cigarette SmokerUnited States
-
M.D. Anderson Cancer CenterNational Institute on Drug Abuse (NIDA); National Cancer Institute (NCI)CompletedCurrent Smoker | Cigarette SmokingUnited States
-
University of UtahNational Cancer Institute (NCI); University of MichiganRecruitingTobacco Smoking | Current SmokerUnited States
-
M.D. Anderson Cancer CenterNational Institute on Drug Abuse (NIDA); National Cancer Institute (NCI)CompletedCurrent Every Day Smoker | Cigarette Smoker | StudentUnited States
Clinical Trials on Laboratory Biomarker Analysis
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedProstate Cancer
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingLeukemia | Acute Lymphoblastic Leukemia | Acute Promyelocytic LeukemiaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedUntreated Adult Acute Lymphoblastic Leukemia | Untreated Childhood Acute Lymphoblastic LeukemiaUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Lymphoblastic Leukemia in Remission | Recurrent Childhood Acute Lymphoblastic LeukemiaUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung CancerUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed
-
Children's Oncology GroupNational Cancer Institute (NCI)WithdrawnClear Cell Renal Cell Carcinoma | Rhabdoid Tumor of the Kidney | Congenital Mesoblastic Nephroma | Childhood Kidney NeoplasmUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)WithdrawnBreast Carcinoma | BRCA1 Mutation Carrier | BRCA2 Mutation CarrierUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedWilms Tumor and Other Childhood Kidney TumorsUnited States