RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if surgery is more effective with or without preoperative chemotherapy in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying surgery and preoperative chemotherapy to see how well they work compared to surgery alone in treating patients with resectable non-small cell lung cancer.

Condition	Treatment or Intervention	Phase
stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage 0 non-small cell lung cancer	Drug: carboplatin  Drug: cisplatin  Drug: docetaxel  Drug: gemcitabine  Drug: ifosfamide  Drug: mitomycin  Drug: paclitaxel  Drug: vinblastine  Drug: vinorelbine  Procedure: chemotherapy  Procedure: conventional surgery  Procedure: neoadjuvant therapy  Procedure: surgery	Phase III

Further Study Details: 

OBJECTIVES: Primary

• Compare the survival of patients with resectable non-small cell lung cancer treated with surgery with or without preoperative chemotherapy.

Secondary

• Compare the quality of life of patients treated with these regimens.
• Compare pre-randomization clinical and post-surgical pathological staging in patients treated with these regimens.
• Compare resectability rates in patients treated with these regimens.
• Compare time to and site of relapse in patients treated with these regimens.
• Determine response in patients treated with preoperative chemotherapy.
• Determine the adverse effects of preoperative chemotherapy in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo surgical resection no more than 4 weeks after randomization.
• Patients receive one of the following chemotherapy regimens immediately after randomization:
• Regimen 1: Patients receive mitomycin IV, vinblastine IV, and cisplatin IV on day 1.
• Regimen 2: Patients receive mitomycin IV, ifosfamide IV over 3 hours, and cisplatin IV over 1 hour on day 1.
• Regimen 3: Patients receive cisplatin IV over 2 hours on day 1 and vinorelbine IV over 5 -10 minutes on days 1 and 8.
• Regimen 4: Patients receive paclitaxel IV and carboplatin IV on day 1.
• Regimen 5: Patients receive gemcitabine IV on days 1 and 8 and cisplatin IV over 2 hours on day 1.
• Regimen 6: Patients receive docetaxel IV and carboplatin IV on day 1. In all regimens, treatment repeats every 3 weeks for a total of 3 courses. Patients undergo surgical resection at least 4 weeks after the last course of chemotherapy.

Quality of life is assessed at 6 and 12 months and then annually thereafter.

Patients are followed 1 month after surgery, 6 months after randomization, every 3 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study.

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven non-small cell lung cancer
• Resectable disease
• Previously untreated disease
• No evidence of distant metastases

PATIENT CHARACTERISTICS: Age:

• Any age

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 3,000/mm^3
• Neutrophil count greater than 1,500/mm^3
• Platelet count greater than 100,000/mm^3

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Considered fit for chemotherapy and surgical resection
• No other disease or prior malignancy that would preclude study treatment
• No active infection

PRIOR CONCURRENT THERAPY: Biologic therapy:

• No concurrent prophylactic colony-stimulating factors (except for secondary prophylaxis)
• No concurrent immunotherapy

Chemotherapy:

• Not specified

Endocrine therapy:

• No concurrent hormonal agents, except corticosteroids

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No other concurrent anticancer therapy

United Kingdom, England
      Medical Research Council Clinical Trials Unit, London,  England,  NW1 2DA,  United Kingdom; Recruiting
      Royal Marsden NHS Foundation Trust - Surrey, Sutton,  England,  SM2 5PT,  United Kingdom; Recruiting

Study chairs or principal investigators

Adrian Hodson,  Medical Research Council   
Ian Edward Smith, MD,  Royal Marsden NHS Trust   

Study ID Numbers:  CDR0000065952; MRC-LU22; EORTC-08012; EU-97016; ISRCTN25582437; NCT00003159
Record last reviewed:  January 2005
Last Updated:  March 3, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003159
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08