Sorafenib in Resected Non-small Cell Lung Carcinoma
Status:
Terminated
Trial end date:
2008-09-01
Target enrollment:
Participant gender:
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
cisplatin/vinorelbine-based cytotoxic chemotherapy in published randomized trials.