Trial Information

A Multicentre Randomised Double Blind Placebo-Controlled Phase II Study of Celecoxib and Concurrent Radiotherapy in Stage II-III NSCLC. An Evaluation of Both Tumor Radiosensitization and Normal Tissue Protection

Treatment of non-small cell lung cancer (NSCLC) is difficult, even with the best classical
radiation and chemotherapy schedule results remain disappointing. However, there is evidence
that increasing the local control rate by delivering radiotherapy either in a short period
of time or concomitantly with chemotherapy improves survival. Drawback of a higher radiation
dose or addition of chemotherapy is a higher incidence of toxicity. So radiation dose
escalation could lead to further improvements of prognosis, but the radiation dose is
however limited by radiation-induced lung and esophageal damage.

For NSCLC, non-toxic agents who both increase the effectiveness of radiotherapy and decrease
radiation induced lung and esophageal damage are needed. The cox-2-inhibitors seem to be
suitable for this purpose. In experimental mice tumor models, it was already shown that
COX-2-inhibitors both inhibit tumor growth and enhance the radio-response of the tumor.
Moreover, anti-inflammatory agents, such asCOX-2-inhibitors, also lowered the incidence of
radiation pneumonitis and esophagitis.

In this study the simultaneous favourable effects of COX-2 inhibitors on tumor response and
radiation damage in human cancer patients will be investigated.

Patients will be randomised to receive Celecoxib or placebo. All patients will receive the
same radiotherapy treatment. Primary outcome measure is tumor response, assessed by a
CT-scan of the thorax, three months after radiotherapy.

The tumor response rate of the experimental group will be compared to the tumor response
rate of the control group.