Combination Chemotherapy in Treating Patients With Stage I, II, or IIIA Non-small Cell Lung Cancer That Has Been Surgically Removed

Adjuvant Treatment of Non Small Cell Lung Cancer

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00003053

Enrollment

750

Registered

2003-01-27

Start date

1994-01-31

Completion date

Unknown

Last updated

2013-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer

Brief summary

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.

Detailed description

OBJECTIVES: * 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.

Interventions

DRUGcisplatin

DRUGetoposide

PROCEDUREadjuvant therapy

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

No minimum to 70 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically proven stage I, II, or IIIA non-small cell lung cancer after radical surgery * No evidence of lymphonodal enlargement during postsurgical chest CT scan PATIENT CHARACTERISTICS: Age: * 70 and under Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Not specified Renal: * Creatinine no greater than 1.5 times the upper limit of normal Pulmonary: * FEV1 at least 1 liter Other: * Less than 10% weight loss in the past 3 months * No prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Radical surgery required

Countries

Greece, Italy, South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026