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

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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Carcinoma Drug: Celecoxib Phase 2

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 : Interventional  (Clinical Trial)
Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2003
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib
U.S. FDA Resources

Primary Outcome Measures :
  1. tumor response rate

Secondary Outcome Measures :
  1. local progression free survival 9 months after radiotherapy
  2. radiopneumonitis
  3. lung fibrosis,6 month post radiotherapy
  4. acute esophagitis
  5. quality of life
  6. survival after 1 year
  7. survival after 2 years

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00181532

Maastircht Radiation Oncology
Heerlen, Limburg, Netherlands, 6411 PC
Sponsors and Collaborators
Maastricht Radiation Oncology
Principal Investigator: Dirk De Ruysscher, PHD Maastricht Radiation Oncology (MAASTRO-clinic) Identifier: NCT00181532     History of Changes
Other Study ID Numbers: P02.1376L
CKTO 2003-07
IKL 2003-02
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: June 30, 2009
Last Verified: June 2009

Keywords provided by Maastricht Radiation Oncology:

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents