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
4 other identifiers
interventional
102
1 country
1
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 hypothesis is that celecoxib will increase the remission rate of radiotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2003
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedJune 30, 2009
June 1, 2009
September 13, 2005
June 29, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
tumor response rate
Secondary Outcomes (7)
local progression free survival 9 months after radiotherapy
radiopneumonitis
lung fibrosis,6 month post radiotherapy
acute esophagitis
quality of life
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht Radiation Oncologylead
- Pfizercollaborator
Study Sites (1)
Maastircht Radiation Oncology
Heerlen, Limburg, 6411 PC, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dirk De Ruysscher, PHD
Maastricht Radiation Oncology (MAASTRO-clinic)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
May 1, 2003
Study Completion
January 1, 2008
Last Updated
June 30, 2009
Record last verified: 2009-06