Lung CancerPhase 1/2NCT00046839
Celecoxib and Radiation Therapy in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer
A Phase 1/2 study testing celecoxib and radiation therapy in people with Lung Cancer, run by Radiation Therapy Oncology Group at 44 sites in United States.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor and may make the tumor cells more sensitive to radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- celecoxib and radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 44 sitesUnited States
- Study dates
- Jul 2002to Sep 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer
- Inoperable stage IIB OR
- Unresectable stage IIIA or IIIB
- No evidence of hematogenous metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 2 AND more than 5% weight loss over the past 3 months OR
- Zubrod 0-1 AND less than 5% weight loss over the past 3 months and refuses chemotherapy or are medically unable to tolerate combined modality therapy
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin no greater than 2 times upper limit of normal
- International Normalized Ratio (INR) no greater than 3.0 if taking warfarin
Renal
- Creatinine clearance at least 50 mL/min
Other
- No active gastrointestinal ulcers or bleeding within the past 3 months
- No other malignancy within the past 3 years except nonmelanoma skin cancer
- No known hypersensitivity to celecoxib
- No prior allergic-type reactions to sulfonamides
- No prior asthma, urticaria, or allergic-type reactions to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior neoadjuvant chemotherapy
- No concurrent chemotherapy
Endocrine therapy
- No concurrent corticosteroids
Radiotherapy
- No prior thoracic radiotherapy
Surgery
- No prior complete or subtotal tumor resection
Other
- No concurrent NSAIDs, lithium, furosemide, or angiotensin-converting enzyme inhibitors
- Concurrent aspirin (325 mg/day) for cardioprotection allowed
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Akron City Hospital at Summa Health System
Akron, Ohio, 44304
Albuquerque Regional Medical Center at Lovelace Sandia Health System
Albuquerque, New Mexico, 87102
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, 87106
Radiation Oncology Center
Alliance, Ohio, 44601
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, 98225
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Memorial Hospital Cancer Center
Colorado Springs, Colorado, 80909
Wendt Regional Cancer Center at Finley Hospital
Dubuque, Iowa, 52001
University of Florida Shands Cancer Center
Gainesville, Florida, 32610
CCOP - Greenville
Greenville, South Carolina, 29615
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, 60426
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, 32207
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
CCOP - Kansas City
Kansas City, Missouri, 64131
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
Monmouth Medical Center
Long Branch, New Jersey, 07740
Community Memorial Hospital
Menomonee Falls, Wisconsin, 53051
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55403
Trinity Cancer Care Center
Minot, North Dakota, 58701
Fox Chase Virtua Health Cancer Program - Marlton
Mount Holly, New Jersey, 08060
Cancer Center at Paoli Memorial Hospital
Paoli, Pennsylvania, 19301
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84603
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, 53405
Regional Radiation Oncology Center at Rome
Rome, Georgia, 30165
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
Park Nicollet Clinic
Saint Louis Park, Minnesota, 55416
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Salem, Ohio, 44460
LDS Hospital
Salt Lake City, Utah, 84143
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, 18501
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29304
St. John's Regional Health Center
Springfield, Missouri, 65804
Dixie Regional Medical Center
St. George, Utah, 84770
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, 74136
University of Wisconsin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, 54401
Cancer Treatment Center
Wooster, Ohio, 44691
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096
North Star Lodge Cancer Center
Yakima, Washington, 98902
About this study
Official title: A Phase I/II Trial of a COX-2 Inhibitor, Celebrex (Celecoxib), [National Screening Committee# 719627] With Limited Field Radiation for Intermediate Prognosis Patients With Locally Advanced Non-Small Cell Lung Cancer, With Analysis of Prognostic Factors
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor and may make the tumor cells more sensitive to radiation therapy.
PURPOSE: Phase I/II trial to study the effectiveness of combining celecoxib with radiation therapy in treating patients who have locally advanced non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and the recommended phase II dose of concurrent celecoxib and limited-field radiotherapy in intermediate-prognosis patients with locally advanced non-small cell lung cancer.
- Determine the efficacy and toxicity of this regimen in these patients.
- Determine how the predictors of mortality in the general population (i.e., comorbid conditions, functional status, quality of life, and psychological status) influence prognosis, toxicity, and outcomes of therapy in patients treated with this regimen.
- Correlate circulating levels of vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), and interleukin-8 (IL8) with survival in patients treated with this regimen.
- Correlate circulating levels of interleukin-1 (IL1), interleukin-6 (IL6), and transforming growth factor-beta (TGFB) with pulmonary toxicity in patients treated with this regimen.
OUTLINE: This is a phase I dose-escalation study of celecoxib followed by a phase II, multicenter study.
- Phase I: Patients receive oral celecoxib twice daily. Beginning on day 6, patients undergo thoracic radiotherapy 5 days a week for 3-6.5 weeks . Patients continue to receive celecoxib for up to 2 years in the absence of disease progression or unacceptable toxicity.
- Phase II: If fewer than 3 of the first 6 patients experience dose-limiting toxicity, then the dose of celecoxib is escalated for all patients in the study, including those in the first cohort.
Quality of life is assessed at baseline and at 3, 6, and 12 months after start of therapy.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 6-12 patients will be accrued for the phase I portion of this study and a total of 116 patients will be accrued for the phase II portion of this study within 25 months.
- Conditions
- Lung Cancer
- Being tested
- celecoxib, radiation therapy
- Keywords
- stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, 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
Also called COX-2 Inhibitor
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Celecoxib 200mg BID + RT | Experimental | COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.
Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy. Receives: Drug: celecoxib; Radiation: radiation therapy |
| Phase I: Celecoxib 400mg BID + RT | Experimental | COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.
Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy. Receives: Drug: celecoxib; Radiation: radiation therapy |
| Phase II: Celecoxib 400mg BID + RT | Experimental | COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.
Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy. Receives: Drug: celecoxib; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Celecoxib Combined With Radiation Therapy (RT)
Patients were followed for at least 90 days from start of RT and carefully evaluated with respect to treatment morbidity. A dose limiting toxicity (DLT) was defined as grade 3 or 4 nonhematologic (excluding nausea, vomiting, and alopecia) and grade 4 hematologic toxicities. Six patients were to be accrued at each dose level. If no more than three of the six patients experienced a DLT then that dose level was considered acceptable and dose escalation occurred by accruing six more patients at the next dose level. Otherwise, the preceding dose level, if any, would be declared the MTD. The MTD would be used for the Phase II arm. At a given dose, the probability of halting dose escalation when the true toxicity is 50% or higher is at least 66% (power). In addition, if the true DLT rate is instead 20%, there will still be a 10% probability of halting dose escalation at a given dose level (type I error).
Rating scale: 0 = not the MTD, 1 = MTD
Measured: Start of treatment to 90 days
Overall Survival
Because only 21 patients (18 analyzable) out of 128 planned were accrued on this study, all analyzable patients were combined to report overall survival. The original study design planned for a comparison to a historical control, but due to the small number of patients, survival time is only reported, not tested.
Measured: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJul 2002
- Primary completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elizabeth M. Gore, MD, Study chair, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046839
- Sponsor's protocol ID
- RTOG-0213
- Other IDs
- CDR0000069476
- Status last verified
- Nov 2015
- First submitted
- 3 Oct 2002
- Last updated
- 17 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gore E, Bae K, Langer C, Extermann M, Movsas B, Okunieff P, Videtic G, Choy H. Phase I/II trial of a COX-2 inhibitor with limited field radiation for intermediate prognosis patients who have locally advanced non-small-cell lung cancer: radiation therapy oncology group 0213. Clin Lung Cancer. 2011 Mar;12(2):125-30. doi: 10.1016/j.cllc.2011.03.007. Epub 2011 Apr 11.
PubMed 21550559
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of a COX-2 Inhibitor, Celebrex (Celecoxib), [National Screening Committee# 719627] With Limited Field Radiation for Intermediate Prognosis Patients With Locally Advanced Non-Small Cell Lung Cancer, With Analysis of Prognostic Factors
- ClinicalTrials.gov ID
- NCT00046839
- Acronym / sponsor ID
- RTOG-0213
- Conditions
- Lung Cancer
- Keywords
- stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2002
- Primary completion
- Sep 2011 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 17 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor and may make the tumor cells more sensitive to radiation therapy.
PURPOSE: Phase I/II trial to study the effectiveness of combining celecoxib with radiation therapy in treating patients who have locally advanced non-small cell lung cancer.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and the recommended phase II dose of concurrent celecoxib and limited-field radiotherapy in intermediate-prognosis patients with locally advanced non-small cell lung cancer.
- Determine the efficacy and toxicity of this regimen in these patients.
- Determine how the predictors of mortality in the general population (i.e., comorbid conditions, functional status, quality of life, and psychological status) influence prognosis, toxicity, and outcomes of therapy in patients treated with this regimen.
- Correlate circulating levels of vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), and interleukin-8 (IL8) with survival in patients treated with this regimen.
- Correlate circulating levels of interleukin-1 (IL1), interleukin-6 (IL6), and transforming growth factor-beta (TGFB) with pulmonary toxicity in patients treated with this regimen.
OUTLINE: This is a phase I dose-escalation study of celecoxib followed by a phase II, multicenter study.
- Phase I: Patients receive oral celecoxib twice daily. Beginning on day 6, patients undergo thoracic radiotherapy 5 days a week for 3-6.5 weeks . Patients continue to receive celecoxib for up to 2 years in the absence of disease progression or unacceptable toxicity.
- Phase II: If fewer than 3 of the first 6 patients experience dose-limiting toxicity, then the dose of celecoxib is escalated for all patients in the study, including those in the first cohort.
Quality of life is assessed at baseline and at 3, 6, and 12 months after start of therapy.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 6-12 patients will be accrued for the phase I portion of this study and a total of 116 patients will be accrued for the phase II portion of this study within 25 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I: Celecoxib 200mg BID + RT | Experimental | Drug: celecoxib, Radiation: radiation therapyCOX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression. Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy. |
| Phase I: Celecoxib 400mg BID + RT | Experimental | Drug: celecoxib, Radiation: radiation therapyCOX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression. Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy. |
| Phase II: Celecoxib 400mg BID + RT | Experimental | Drug: celecoxib, Radiation: radiation therapyCOX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression. Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| celecoxibAlso: COX-2 Inhibitor | Drug | Phase I: Celecoxib 200mg BID + RT, Phase I: Celecoxib 400mg BID + RT, Phase II: Celecoxib 400mg BID + RT |
| radiation therapy | Radiation | Phase I: Celecoxib 200mg BID + RT, Phase I: Celecoxib 400mg BID + RT, Phase II: Celecoxib 400mg BID + RT |
Primary outcome
Maximum Tolerated Dose (MTD) of Celecoxib Combined With Radiation Therapy (RT)
Time frame: Start of treatment to 90 days
Patients were followed for at least 90 days from start of RT and carefully evaluated with respect to treatment morbidity. A dose limiting toxicity (DLT) was defined as grade 3 or 4 nonhematologic (excluding nausea, vomiting, and alopecia) and grade 4 hematologic toxicities. Six patients were to be accrued at each dose level. If no more than three of the six patients experienced a DLT then that dose level was considered acceptable and dose escalation occurred by accruing six more patients at the next dose level. Otherwise, the preceding dose level, if any, would be declared the MTD. The MTD would be used for the Phase II arm. At a given dose, the probability of halting dose escalation when the true toxicity is 50% or higher is at least 66% (power). In addition, if the true DLT rate is instead 20%, there will still be a 10% probability of halting dose escalation at a given dose level (type I error). Rating scale: 0 = not the MTD, 1 = MTD
Overall Survival
Time frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.
Because only 21 patients (18 analyzable) out of 128 planned were accrued on this study, all analyzable patients were combined to report overall survival. The original study design planned for a comparison to a historical control, but due to the small number of patients, survival time is only reported, not tested.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21550559Gore E, Bae K, Langer C, Extermann M, Movsas B, Okunieff P, Videtic G, Choy H. Phase I/II trial of a COX-2 inhibitor with limited field radiation for intermediate prognosis patients who have locally advanced non-small-cell lung cancer: radiation therapy oncology group 0213. Clin Lung Cancer. 2011 Mar;12(2):125-30. doi: 10.1016/j.cllc.2011.03.007. Epub 2011 Apr 11.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Elizabeth M. Gore, MD study chair
Medical College of Wisconsin
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing celecoxib and radiation therapy in people with Lung Cancer, run by Radiation Therapy Oncology Group at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 17 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Tolerated Dose (MTD) of Celecoxib Combined With Radiation Therapy (RT) (time frame: Start of treatment to 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00046839, which also lists 1 linked publication.
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 17 Nov 2015.