Phase II Study of Celecoxib and Concurrent Radiotherapy in Stage II-III NSCLC
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|ClinicalTrials.gov Identifier: NCT00181532|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 30, 2009
|First Submitted Date ICMJE||September 13, 2005|
|First Posted Date ICMJE||September 16, 2005|
|Last Update Posted Date||June 30, 2009|
|Study Start Date ICMJE||May 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||tumor response rate|
|Original Primary Outcome Measures ICMJE||Same as current|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Phase II Study of Celecoxib and Concurrent Radiotherapy in Stage II-III NSCLC|
|Official Title ICMJE||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|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Condition ICMJE||Non Small Cell Lung Carcinoma|
|Intervention ICMJE||Drug: Celecoxib|
|Study Arms ICMJE||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Actual Study Completion Date ICMJE||January 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages ICMJE||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Netherlands|
|Removed Location Countries|
|NCT Number ICMJE||NCT00181532|
|Other Study ID Numbers ICMJE||P02.1376L
MEC MAASTRO 0205
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Maastricht Radiation Oncology|
|PRS Account||Maastricht Radiation Oncology|
|Verification Date||June 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP