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Trial record 1 of 1 for:    NCT00181532
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Phase II Study of Celecoxib and Concurrent Radiotherapy in Stage II-III NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00181532
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 30, 2009
Information provided by:
Maastricht Radiation Oncology

Tracking Information
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
 (submitted: September 13, 2005)
tumor response rate
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • local progression free survival 9 months after radiotherapy
  • radiopneumonitis
  • lung fibrosis,6 month post radiotherapy
  • acute esophagitis
  • quality of life
  • survival after 1 year
  • survival after 2 years
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
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
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.

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 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
Masking: Double
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 Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 13, 2005)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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  
Administrative Information
NCT Number  ICMJE NCT00181532
Other Study ID Numbers  ICMJE P02.1376L
CKTO 2003-07
IKL 2003-02
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
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Dirk De Ruysscher, PHD Maastricht Radiation Oncology (MAASTRO-clinic)
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