Carcinoma, Non-Small-Cell Lung Clinical Trial
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
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 cisplatin/vinorelbine-based cytotoxic chemotherapy in published randomized trials.
n/a
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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