Phase II Study of Celecoxib and Concurrent Radiotherapy in Stage II-III NSCLC

• ClinicalTrials.gov Identifier: NCT00181532
• Recruitment Status: Completed
• First Posted: September 16, 2005
• Last Update Posted: June 30, 2009
• Sponsor: Maastricht Radiation Oncology
• Collaborator: Pfizer
• Information provided by: Maastricht Radiation Oncology

Tracking Information

• First Submitted Date: September 13, 2005
• First Posted Date: September 16, 2005
• Last Update Posted Date: June 30, 2009
• Study Start Date: May 2003
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: September 13, 2005): tumor response rate
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase II Study of Celecoxib and Concurrent Radiotherapy in Stage II-III NSCLC
• 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

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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Non Small Cell Lung Carcinoma
• Intervention: Drug: Celecoxib
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 13, 2005): 102
• Original Enrollment: Same as current
• Actual Study Completion Date: January 2008
• Primary Completion Date: Not Provided

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT00181532
• Other Study ID Numbers: P02.1376L; CKTO 2003-07; IKL 2003-02; MEC MAASTRO 0205
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Maastricht Radiation Oncology
• Collaborators: Pfizer

Investigators

• Principal Investigator: Dirk De Ruysscher, PHD; Maastricht Radiation Oncology (MAASTRO-clinic)

• PRS Account: Maastricht Radiation Oncology
• Verification Date: June 2009