Phase II Study of Celecoxib and Concurrent Radiotherapy in Stage II-III NSCLC

Maastricht Radiation Oncology

Status and phase

Completed

Phase 2

Conditions

Non Small Cell Lung Carcinoma

Treatments

Drug: Celecoxib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00181532

P02.1376L

MEC MAASTRO 0205

CKTO 2003-07

IKL 2003-02

Details and patient eligibility

About

The purpose of this study is to investigate the effect of the adminstration of celecoxib, a cox2-inhibitor in patients with stage II-III non small cell lung cancer receiving radical radiotherapy.

The hypothesis is that celecoxib will increase the remission rate of radiotherapy.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

histologically proven non-small cell lung cancer
UICC stage II-III
WHO performance status 0-2
less than 10% weight loss the last 6 month
in case of previous chemotherapy, radiotherapy may start after a minimum of 21 days after the last chemotherapy course
reasonable lung function: FEV1>30% of the predicted value
no recent(<3month) severe cardiac disease
no active peptic ulcer disease
normal serum bilirubin
normal serum creatinin
life expectancy more than 6 month
measurable cancer
willing and able to comply with the study prescriptions
able to give written informed consent before patient registration/randomisation
no previous radiotherapy to the chest

Exclusion criteria

not not small cell histology, e.g. mesothelioma, lymphoma
mixed pathology, e.g. non small cell plus small cell cancer
malignant pleural or pericardial effusion
concurrent chemotherapy with radiation
recent (<3month) myocardial infarction
uncontrolled infectious disease
distant metastases (stage IV)
patients with active peptic ulceration or gastrointestinal bleeding in the last year
patients with a past history of adverse reaction to NSAIDs
renal disease
chronic use of NSAIDs, COX-2 inhibitors or Aspirin in dosis >120mg/day.