drugset / Trial / NCT00321893
Budesonide in Treating Patients With Lung Nodules at High Risk of Developing Lung Cancer
RandomizedParallel-groupTriple-blindPrevention
Summary
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.
Timeline
- Start
- 2006-01
- Primary completion
- 2008-09
- Completion
- 2008-09
Publications
- Fumagalli C, Bianchi F, Raviele PR, Vacirca D, Bertalot G, Rampinelli C, Lazzeroni M, Bonanni B, Veronesi G, Fusco N, Barberis M, Guerini-Rocco E. Circulating and tissue biomarkers in early-stage non-small cell lung cancer. Ecancermedicalscience. 2017 Jan 31;11:717. doi: 10.3332/ecancer.2017.717. eCollection 2017.
- Veronesi G, Szabo E, Decensi A, Guerrieri-Gonzaga A, Bellomi M, Radice D, Ferretti S, Pelosi G, Lazzeroni M, Serrano D, Lippman SM, Spaggiari L, Nardi-Pantoli A, Harari S, Varricchio C, Bonanni B. Randomized phase II trial of inhaled budesonide versus placebo in high-risk individuals with CT screen-detected lung nodules. Cancer Prev Res (Phila). 2011 Jan;4(1):34-42. doi: 10.1158/1940-6207.CAPR-10-0182. Epub 2010 Dec 16.
- Lazzeroni M, Guerrieri-Gonzaga A, Serrano D, Varricchio MC, Veronesi G, Radice D, Feroce I, Nardi-Pantoli A, Lippman SM, Szabo E, Bonanni B. Budesonide versus placebo in high-risk population with screen-detected lung nodules: rationale, design and methodology. Contemp Clin Trials. 2010 Nov;31(6):612-9. doi: 10.1016/j.cct.2010.08.006. Epub 2010 Aug 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | 800 ug | Inhaled |