Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer

United Kingdom Research and Innovation (UKRI)

Status and phase: Completed; Phase 3

Conditions: Lung Cancer

Treatments: Procedure: neoadjuvant therapy; Procedure: conventional surgery; Drug: docetaxel; Drug: ifosfamide; Drug: cisplatin; Drug: mitomycin C; Drug: carboplatin; Drug: gemcitabine hydrochloride; Drug: paclitaxel; Drug: vinblastine sulfate; Drug: vinorelbine tartrate

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT00003159

EU-97016

CDR0000065952

ISRCTN25582437

EORTC-08012

MRC-LU22

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. 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.

Full description

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.

Arm II: 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.

Enrollment: 600 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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