It is suggested that a bimodal or trimodal approach combining neoadjuvant chemotherapy with or without radiotherapy followed by surgery provides a potentially superior method of enhancing resectability and improving locoregional control and survival compared to radiotherapy alone followed by surgery. Unsolved questions are the identification of the best induction strategy, the impact of surgery on long-term survival, and the contribution of radiation therapy in this setting. Thus, the investigators conduct a phase II trial to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with biopsy proven N2 stage IIIA NSCLC to address optimal induction strategy.
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 cycles
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Paclitaxel 90mg/m2 + Cisplatin 40mg/m2 on D1 \& 8 q 3weeks, Pre-OP \& post-op : 2cycles (total 4 cycles)
Paclitaxel 50mg/m2 + Cisplatin 20mg/m2 on D1 \& 8 q 3weeks, Pre-OP \& post-op : 2cycles (total 4 cycles)
Preoperative Thoracic radiation: 180cGy/fx, total: 4500cGy, 25fx
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea
RECRUITINGTo estimate the time to recurrence
Time frame: 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
To estimate the overall survival
Time frame: from the date of randomization to the date of death
To assess the pathologic complete response rate and the complete resection rate
Time frame: After surgery
To estimate toxicities
Time frame: from the first date of treatment to 30 days after the last dose of study drug
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