Concurrent celecoxib versus placebo in patients with stage II-III non-small cell lung cancer: a randomised phase II trial.

Author(s): De Ruysscher D, Bussink J, Rodrigus P, Kessels A, Dirx M, Houben R, Wanders R

Affiliation(s): MAASTRO Clinic, Maastricht, The Netherlands. dirk.deruysscher@maastro.nl

Publication date & source: 2007-07, Radiother Oncol., 84(1):23-5. Epub 2007 May 25.

Publication type: Clinical Trial, Phase II; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

In several pre-clinical models, cyclooxygenase (COX) inhibitors increase radio-sensitivity of tumours, whilst not affecting normal tissues. A randomised phase II trial comparing concurrent radiotherapy with either celecoxib or placebo in patients with stage II-III non-small cell lung cancer was therefore initiated. Because of poor recruitment, the study was stopped after the enrollment of 41 patients, instead of the foreseen 102. None of the endpoints differed significantly between both groups. However, due to the limited number of patients, no definitive conclusions can be drawn.