Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer (NSCLC) Patients With Operable Stage IIIB Disease: A Prospective Phase II Trial
- Determine the feasibility and efficacy of sequential neoadjuvant docetaxel, cisplatin,
and radiotherapy followed by surgery in patients with operable stage IIIB non-small
cell lung cancer.
- Determine the rate of event-free survival at 1 year in patients treated with this
- Determine the operability and complete resection rate in patients treated with this
- Determine the postoperative 30-day mortality in patients treated with this regimen.
- Determine the response rate, failure pattern, and overall survival in patients treated
with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1. Treatment
repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity.
Beginning 3 weeks after the last chemotherapy dose, patients without progressive disease
receive radiotherapy 1-2 times daily on days 1-5, 8-12, and 15-19.
Patients undergo surgery within 3-4 weeks after completion of radiotherapy.
Patients are followed at 1 month and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15-46 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of event-free survival measured 1 year after registration
Roger Stupp, MD
Centre Hospitalier Universitaire Vaudois