Non Small Cell Lung CarcinomaPhase 2NCT00181532
Phase II Study of Celecoxib and Concurrent Radiotherapy in Stage II-III NSCLC
A Phase 2 study testing Celecoxib in people with Non Small Cell Lung Carcinoma, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Carcinoma
- What is being tested?
- Celecoxib
- How many people
- 102 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2003to Jan 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Non Small Cell Lung Carcinoma
- Being tested
- Celecoxib
- Keywords
- NSCLC, cox-2-inhibitor, radiosensitizer, radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
survival after 1 year
survival after 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2003
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 102 participants
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Dirk De Ruysscher, PHD, Principal investigator, Maastricht Radiation Oncology (MAASTRO-clinic)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181532
- Sponsor's protocol ID
- P02.1376L
- Other IDs
- CKTO 2003-07, IKL 2003-02, MEC MAASTRO 0205
- Status last verified
- Jun 2009
- First submitted
- 13 Sep 2005
- Last updated
- 30 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00181532
- Acronym / sponsor ID
- P02.1376L
- Conditions
- Non Small Cell Lung Carcinoma
- Keywords
- NSCLC, cox-2-inhibitor, radiosensitizer, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2003
- Study completion
- Jan 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celecoxib | Drug | – |
Primary outcome
tumor response rate
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk De Ruysscher, PHD principal investigator
Maastricht Radiation Oncology (MAASTRO-clinic)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib in people with Non Small Cell Lung Carcinoma, run by Maastricht Radiation Oncology at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor response rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2009; AzTrials last refreshed its copy on 7 Nov 2026.