A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Biopsy-Proven N2 Stage IIIA Non-Small Cell Lung Cancer
Preoperative Therapy Arm 1. (preoperative chemotherapy) Paclitaxel (90 mg/m2)on day 1 and 8
Cisplatin (40 mg/m2)on day 1 and 8. q 3 weeks, 2 cycles
Arm 2. (preoperative chemoradiotherapy) Paclitaxel (50 mg/m2)on day 1, 8, 15, 22 & 29
Cisplatin (20 mg/m2)on day 1, 8, 15, 22 & 29. Thoracic radiation therapy (TRT) 1.8 Gy
daily, five times per week (45 Gy target dose in 5 weeks).
Postoperative Consolidation Chemotherapy:
Paclitaxel (90 mg/m2) on day 1 and 8. Cisplatin (40 mg/m2) on day 1 and 8. q 3weeks, 2
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To estimate the time to recurrence
The interval from the date of randomization to the date to the date of the first objective evidence of recurrence or to the date of death, if before recurrence
Heung Tae Kim, M.D.
National Cancer Center, Korea
South Korea: Korea Food and Drug Administration (KFDA)