Phase III Randomised Study Of Adjuvant Paclitaxel And Carboplatin (TAXOL-PARAPLATINE) With Concomittant Radiotherapy In Patients With Stage II or III Non-Metastatic Non-Small Cell Lung Cancer
- Compare the progression-free survival of patients with stage II or III unresectable
non-small cell lung cancer treated with paclitaxel, carboplatin, and radiotherapy with
or without adjuvant paclitaxel and carboplatin.
- Compare the objective response rate in patients treated with these regimens.
- Compare the overall survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
radiotherapy regimen (conformational vs nonconformational).
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly
for up to 6 weeks. Patients concurrently undergo radiotherapy 5 days a week for 7-7.5 weeks.
Three weeks after completion of chemoradiotherapy, patients with stable or responding
disease are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo routine follow-up.
- Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes
on day 1. Treatment repeats every 21 days for a maximum of 3 courses.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 390 patients will be accrued for this study within 3 years.
Allocation: Randomized, Primary Purpose: Treatment
Jean F. Morere, MD
United States: Federal Government