Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer
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.
Drug: gemcitabine hydrochloride
Drug: mitomycin C
Drug: vinblastine sulfate
Drug: vinorelbine tartrate
Procedure: conventional surgery
Procedure: neoadjuvant therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Randomized Trial of Surgical Resection With or Without Pre-Operative Chemotherapy in Patients With Operable Non-Small Cell Lung Cancer (NSCLC) of Any Stage|
- Survival [ Designated as safety issue: No ]
- Quality of life as measured by SF-36 questionnaire at baseline, 6 months, 12 months, and then annually thereafter [ Designated as safety issue: No ]
- Clinical and post-surgery pathological staging at pre-randomization [ Designated as safety issue: No ]
- Resectability rates [ Designated as safety issue: No ]
- Extent of surgery [ Designated as safety issue: No ]
- Time to and site of relapse [ Designated as safety issue: No ]
- Tumor response to chemotherapy [ Designated as safety issue: No ]
- Adverse effects of chemotherapy [ Designated as safety issue: Yes ]
|Study Start Date:||August 1997|
|Study Completion Date:||June 2007|
- Compare the survival of patients with resectable non-small cell lung cancer treated with surgery with or without preoperative chemotherapy.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003159
|Medical Research Council Clinical Trials Unit|
|London, England, United Kingdom, NW1 2DA|
|Royal Marsden NHS Foundation Trust - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Investigator:||Adrian Hodson||Medical Research Council|
|Investigator:||Ian E. Smith, MD||Royal Marsden NHS Foundation Trust|