A Randomized Phase II Trial of Cisplatin/Etoposide and Concurrent Radiotherapy With or Without Celecoxib in Patients With Unresectable Locally Advanced Non-small Cell Lung Cancer
Celecoxib is a non-steroidal-anti-inflammatory drug (NSAIDS) Recent studies have shown that
celecoxib has antitumor activity, and may increase the tumor sensitivity to radiation.
Furthermore, evidence has shown the safety and efficiency of celecoxib in some phase I/II
studies. The purposes of this study are to examine the effects of a new combination of
celecoxib (Celebrex®) and cisplatin/etoposide (EP regimen), with concurrent thoracic
radiotherapy on unresectable stage III NSCLC patients; and to examine biomarkers to predict
response to the treatment. Because of poor survival of patients with unresected locally
advanced NSCLC, the efficiency of celecoxib plus concurrent EP chemoradiotherapy need to be
further investigated.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
overall survival
3 year overall survival
Yes
Luhua Wang, Doctor
Study Director
Cancer Hospital, Chinese Academy of Medical Sciences
United States: Food and Drug Administration
CH-L-025
NCT01503385
December 2011
December 2016
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