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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00321893 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: Budesonide Other: Placebo |
Phase II |
| Study Type: | Interventional |
| 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 |
| Enrollment: | 225 |
| Study Start Date: | January 2006 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I: Budesonide
Inhaled Budesonide twice daily for 1 year
|
Drug: Budesonide
Inhaled Budesonide 800 micrograms twice daily for one year.
Other Names:
|
|
Placebo Comparator: Arm II: Placebo
Inhaled placebo twice daily for 1 year
|
Other: Placebo
Inhaled placebo twice daily for one year.
|
OBJECTIVES:
Primary
Secondary
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.
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Italy | |
| 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 |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00321893 History of Changes |
| Other Study ID Numbers: | 2005-0953, MDA-05-5-01, MDA-S262/505, MDA-2005-0953, EUDRACT-2005-004614-32, CDR0000470861 |
| Study First Received: | May 2, 2006 |
| Last Updated: | November 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Small cell lung cancer Non-small cell lung cancer Budesonide Entocort EC |
Pulmicort Respules Rhinocort aqua Aerosol budesonide treatment Smoking |
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Budesonide Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents |