Combination Chemotherapy in Treating Patients With Stage I, II, or IIIA Non-small Cell Lung Cancer That Has Been Surgically Removed
|ClinicalTrials.gov Identifier: NCT00003053|
Recruitment Status : Unknown
Verified January 2008 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare cisplatin and etoposide with no chemotherapy in treating patients who have stage I, stage II, or stage IIIA non-small cell lung cancer that has been surgically removed.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: cisplatin Drug: etoposide Procedure: adjuvant therapy||Phase 3|
- Assess the efficacy of the combination of cisplatin and etoposide after radical surgery in prolonging the relapse free and overall survival for stages I, II, and IIIA non-small cell lung cancer.
OUTLINE: This a randomized study (treatment vs no treatment). Patients are stratified according to sex and to stage of disease (I vs II vs IIIA).
Patient receives cisplatin and etoposide on days 1-3, every 28 days, for 3 cycles. Patient may receive radiation therapy after surgery at the discretion of the physician.
PROJECTED ACCRUAL: Approximately 750 patients will be accrued over 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|Official Title:||Adjuvant Treatment of Non Small Cell Lung Cancer|
|Study Start Date :||January 1994|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003053
Show 86 Study Locations
|Study Chair:||Antonio Nicolucci, MD||Consorzio Mario Negri Sud|