Randomized Trial of Surgical Resection With or Without Pre-Operative Chemotherapy in Patients With Operable Non-Small Cell Lung Cancer (NSCLC) of Any Stage
N/A
N/A
Both
Lung Cancer
Trial Information
Randomized Trial of Surgical Resection With or Without Pre-Operative Chemotherapy in Patients With Operable Non-Small Cell Lung Cancer (NSCLC) of Any Stage
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Survival
Safety Issue:
No
Principal Investigator
Adrian Hodson
Investigator Affiliation:
Medical Research Council
Authority:
United States: Federal Government
Study ID:
CDR0000065952
NCT ID:
NCT00003159
Start Date:
August 1997
Completion Date:
Related Keywords:
- Lung Cancer
- 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
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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