NCT00003159

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

Randomized Trial of Surgical Resection With or Without Pre-Operative Chemotherapy in Patients With Operable Non-Small Cell Lung Cancer (NSCLC) of Any Stage

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Medical Research Council · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	cisplatin
DRUG	docetaxel
DRUG	gemcitabine hydrochloride
DRUG	ifosfamide
DRUG	mitomycin C
DRUG	paclitaxel
DRUG	vinblastine sulfate
DRUG	vinorelbine tartrate
PROCEDURE	conventional surgery
PROCEDURE	neoadjuvant therapy

Timeline

• Start date: 1997-08-01
• Completion: 2007-06-01
• First posted: 2003-01-27
• Last updated: 2013-12-04

Locations

2 sites across 1 country: United Kingdom