Spots Global Cancer Trial Database for Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in N2 Positive IIIA Non Small Cell Lung Cancer (NSCLC)

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Trial Identification

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

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

Study ID: NCT00452803

Conditions

Lung Cancer

Interventions

chemotherapy

Concurrent chemoradiation therapy

Study Description

Brief 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