Ignite Creation Date:
2024-05-05 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00532025
Status:
TERMINATED
Last Update Posted:
2009-07-28
First Post:
2007-09-18
Brief Title:
Sorafenib in Resected Non-small Cell Lung Carcinoma
Sponsor:
Johannes Gutenberg University Mainz
Organization:
Johannes Gutenberg University Mainz
Study Overview
Official Title:
A Phase II Study to Investigate the Efficacy and Safety of Sorafenib as Adjuvant Treatment Following Resection of Non-small Cell Lung Carcinoma NSCLC in Patients Not Eligible for Cisplatin-based Adjuvant Chemotherapy
Status:
TERMINATED
Status Verified Date:
2009-07
Last Known Status:
None
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:
SIRN
Brief Summary:
This is an open-label single-armed multicentric phase II study of Sorafenib treatment following surgery for NSCLC
The primary hypothesis is to increase the progression-free survival PFS of the experimental group in comparison to a historical control group For sample size calculation a 2 year PFS of 50 was calculated for the historical control group and a 2 year PFS of 67 was estimated for the intervention group These estimates are based on the actual PFS and overall survival OS of a defined population of 120 NSCLC patients treated at a single institution with surgery alone or surgery followed by adjuvant radiotherapy which compares favorably to published international results and the improvement of PFS achieved by 4 cycles of cisplatinvinorelbine-based cytotoxic chemotherapy in published randomized trials
The primary hypothesis is to increase the progression-free survival PFS of the experimental group in comparison to a historical control group For sample size calculation a 2 year PFS of 50 was calculated for the historical control group and a 2 year PFS of 67 was estimated for the intervention group These estimates are based on the actual PFS and overall survival OS of a defined population of 120 NSCLC patients treated at a single institution with surgery alone or surgery followed by adjuvant radiotherapy which compares favorably to published international results and the improvement of PFS achieved by 4 cycles of cisplatinvinorelbine-based cytotoxic chemotherapy in published randomized trials
Detailed Description:
None
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