Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452803
Status:
UNKNOWN
Last Update Posted:
2010-07-12
First Post:
2007-03-27
Brief Title:
Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in N2 Positive IIIA Non Small Cell Lung Cancer NSCLC
Sponsor:
National Cancer Center Korea
Organization:
National Cancer Center Korea
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2010-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgm2on day 1 and 8 Cisplatin 40 mgm2on day 1 and 8 q 3 weeks 2 cycles
Arm 2 preoperative chemoradiotherapy Paclitaxel 50 mgm2on day 1 8 15 22 29 Cisplatin 20 mgm2on day 1 8 15 22 29 Thoracic radiation therapy TRT 18 Gy daily five times per week 45 Gy target dose in 5 weeks
Postoperative Consolidation Chemotherapy
Paclitaxel 90 mgm2 on day 1 and 8 Cisplatin 40 mgm2 on day 1 and 8 q 3weeks 2 cycles
Arm 2 preoperative chemoradiotherapy Paclitaxel 50 mgm2on day 1 8 15 22 29 Cisplatin 20 mgm2on day 1 8 15 22 29 Thoracic radiation therapy TRT 18 Gy daily five times per week 45 Gy target dose in 5 weeks
Postoperative Consolidation Chemotherapy
Paclitaxel 90 mgm2 on day 1 and 8 Cisplatin 40 mgm2 on day 1 and 8 q 3weeks 2 cycles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None