NCT00452803

Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in N2 Positive IIIA Non Small Cell Lung Cancer (NSCLC)

A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Biopsy-Proven N2 Stage IIIA Non-Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	chemotherapy	Paclitaxel 90mg/m2 + Cisplatin 40mg/m2 on D1 \& 8 q 3weeks, Pre-OP \& post-op : 2cycles (total 4 cycles)
DRUG	Concurrent chemoradiation therapy	Paclitaxel 50mg/m2 + Cisplatin 20mg/m2 on D1 \& 8 q 3weeks, Pre-OP \& post-op : 2cycles (total 4 cycles)
RADIATION	Concurrent chemoradiation therapy	Preoperative Thoracic radiation: 180cGy/fx, total: 4500cGy, 25fx

Timeline

• Start date: 2006-04-01
• Primary completion: 2011-12-01
• Completion: 2012-12-01
• First posted: 2007-03-28
• Last updated: 2010-07-12

Locations

1 site across 1 country: South Korea