Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of budesonide may keep lung cancer from forming in patients with lung nodules.
PURPOSE: This randomized phase II trial is studying how well inhalation budesonide works in treating patients with lung nodules who are at high risk of lung cancer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Randomized Phase II Trial of Budesonide Turbuhaler® 800 Micrograms/Twice Daily Versus Placebo in High-Risk Population With Undetermined Lung Nodules Detected at Screening Low Dose CT Scan|
- Number (and Size) CT-detected Lung Nodules by Participant [ Time Frame: Baseline to 3 Years ] [ Designated as safety issue: No ]Lung nodules in a person-specific analysis by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- Participant Response [ Time Frame: Baseline up to 3 Years ] [ Designated as safety issue: No ]Number of participants with response according to RECIST criteria. For single nodules > 5 mm, clinical meaningful shrinkage of 30% or > of longest diameter (LD) considered treatment success after 1 year of treatment. For single nodules with LD <5 mm, complete disappearance considered treatment success. In case of multiple lesions success of treatment is when complete response (CR) or partial response (PR) occurs according to RECIST criteria.
|Study Start Date:||January 2006|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Arm I: Budesonide
Inhaled Budesonide twice daily for 1 year
Inhaled Budesonide 800 micrograms twice daily for one year.
Placebo Comparator: Arm II: Placebo
Inhaled placebo twice daily for 1 year
Inhaled placebo twice daily for one year.
- Evaluate the effect, in terms of size and number reduction of computed tomography (CT) scan-detected undetermined lung nodules, in asymptomatic subjects with lung nodules at high-risk for developing lung cancer treated with inhaled budesonide vs placebo.
- Compare average modification of nodule size and nodule number due to inhaled budesonide versus placebo.
- Correlate the modulation of biological markers of lung cancer in serum and sputum after treatment with the modification of lung nodules sizes.
- Determine treatment toxicity, side effects, and safety of inhaled budesonide.
- Evaluate the role of CT scans in estimating the grade of respiratory impairment and emphysema.
- Determine the effect of inhaled budesonide on respiratory function before and after treatment.
OUTLINE: This is a randomized, double-blind, placebo controlled study.
Participants are stratified according to gender, smoking habit (current vs former smoker), and nodule characteristics (solid vs semisolid or non-solid). Participants are randomized into 1 of 2 treatment arms.
- Arm I: Subjects receive inhaled budesonide twice daily for 1 year in the absence of unacceptable toxicity.
- Arm II: Subjects receive inhaled placebo twice daily for 1 year in the absence of unacceptable toxicity.
Participants undergo blood and sputum collection periodically during study for biomarker and correlative studies.
After completion of study therapy, subjects are followed at 1 month and continue CT scan screening.
PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.
|European Institute of Oncology|
|Milan, Italy, 20141|
|Study Chair:||Giulia Veronesi, MD||European Institute of Oncology|
|Study Chair:||Scott M. Lippman, MD, FACP||M.D. Anderson Cancer Center|