Trimodality Protocol for the Treatment of Locally Advanced, Potentially Resectable Non-Small Cell Lung Cancer Targeting
- Determine the complete resection rate and toxic death rate of patients with locally
advanced non-small cell lung cancer treated with paclitaxel, carboplatin, and
radiotherapy followed by surgical resection and adjuvant paclitaxel and carboplatin.
- Determine the survival, event-free survival, and incidence of pathologic complete
remission of patients treated with this regimen.
- Determine the protocol completion rate (CR) of patients treated with this regimen.
- Determine the feasibility and toxicity of this regimen in these patients.
- Determine the pathologic response rate/downstaging, pathologic near CR rate, freedom
from distant metastasis rate, and freedom from local regional failure rate of patients
treated with this regimen.
OUTLINE: Patients receive induction therapy comprising radiotherapy 5 days a week for 5.5-6
weeks and paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22,
29, and 36.
Within 1-3 weeks after completion of induction therapy, patients undergo restaging. Patients
with resectable disease undergo surgical resection within 4-8 weeks after induction therapy.
Patients with unresectable disease undergo additional radiotherapy 5 days a week for 3 weeks
and receive paclitaxel and carboplatin as in induction therapy on days 1, 8, and 15.
Within 4-12 weeks after surgery or additional chemoradiotherapy, patients receive adjuvant
therapy comprising paclitaxel and carboplatin as in induction therapy on day 1. Adjuvant
treatment repeats every 4 weeks for 3 courses.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
PROJECTED ACCRUAL: Approximately 57 patients will be accrued for this study within 4 years.
Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
Aruna J. Turaka, MD
Fox Chase Cancer Center
United States: Federal Government
|Fox Chase Cancer Center - Philadelphia||Philadelphia, Pennsylvania 19111-2497|