Trial | NCT00003053  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    750
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.
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.
Study Started
Jan 31
1994
Last Update
Sep 20
2013
Estimate

Drug cisplatin

Drug etoposide

Procedure adjuvant therapy

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
No Results Posted