Status:
COMPLETED
Phase II Study of Celecoxib and Concurrent Radiotherapy in Stage II-III NSCLC
Lead Sponsor:
Maastricht Radiation Oncology
Collaborating Sponsors:
Pfizer
Conditions:
Non Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2008
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00181532
Start Date
May 1 2003
End Date
January 1 2008
Last Update
June 30 2009
Active Locations (1)
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1
Maastircht Radiation Oncology
Heerlen, Limburg, Netherlands, 6411 PC