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

European Institute of Oncology

Status and phase: Unknown; Phase 3

Conditions: Lung Cancer

Treatments: Procedure: adjuvant therapy; Drug: cisplatin; Drug: etoposide

Study type: Interventional

Funder types: Other

Identifiers

NCT00003053

EU-97010

CNR-NICO-01

CDR0000065700

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 estimated patients

Sex: All

Ages: Under 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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