Clinical trial · Interventional
Phase II Study of Celecoxib and Concurrent Radiotherapy in Stage II-III NSCLC
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
NCT00181532CI-TRIAL-00002419completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- tumor response rate
Secondary outcomes (7)
- measure
- local progression free survival 9 months after radiotherapy
- measure
- radiopneumonitis
- measure
- lung fibrosis,6 month post radiotherapy
- measure
- acute esophagitis
- measure
- quality of life
- measure
- survival after 1 year
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.