CancerPhase 1/2RAD0201NCT00581971
Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer
A Phase 1/2 study testing celecoxib, Carboplatin and Paclitaxel in people with Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This is a single-institution, open-label, non-randomized phase IB/II trial of celecoxib administered concurrently with carboplatin, paclitaxel, and radiation therapy in patients with locally advanced or recurrent squamous cell carcinoma of the head and neck. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- celecoxib, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Mar 2012
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven primary squamous cell carcinoma arising in the oropharynx, oral cavity, hypopharynx, or larynx. Patients with recurrences after primary surgery (with no history of radiotherapy or chemotherapy) are also eligible.
- The patient has stage III or IV disease, T3 or higher, or N2 or higher, nonmetastatic. Recurrent need not satisfy these staging requirements on restating, but patients must be nonmetastatic, and either be unresectable, medically inoperable, or refuse further surgery.
- Performance status < 2 (ECOG scale) with a life expectancy of > 12 months.
- Age > 19 years.
- The patient is medically fit to tolerate a course of definitive radiation therapy.
- The patient has:
Show all 14Show fewer
- adequate hepatic function with bilirubin < 1.5 x upper limit of normal (ULN),
- transaminases (SGOT and SGPT) may be up to 2.5 x ULN if alkaline phosphatase is < ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN,
- adequate renal function with serum creatinine < 1.5 mg/dl (or estimated creatinine clearance of > 50 mL/min),
- normal serum calcium,
- adequate hematologic function as: defined by an absolute neutrophil count > 1500/ml, hematocrit > 24 %, and platelet count > 100,000/ml. Patients with hematocrit between 24 % and 30 % should undergo transfusion or treatment with epoetin, and may be enrolled.
- The patient may have had a prior malignancy but must be disease-free for 5 years prior to study entry. A history of superficial non-melanoma skin cancer or in situ carcinoma of the cervix less than three years will be allowed.
- The patient must agree to use effective contraception if procreative potential exists, and continue contraception for at least 3 months following completion of the study.
- Patient must be informed of the investigational nature of the study and sign an informed consent form.
Who cannot join
- The patient has received radiation therapy previously to the head and neck. Previous radiotherapy for skin cancers of the head and neck are permitted if the fields do not overlap.
- The patient has received prior chemotherapy for head and neck cancer.
- The patient is pregnant or lactating.
- Squamous cell carcinoma arising in the nasopharynx, sinuses, salivary glands, or the primary is unknown.
- Non-squamous histologies (such as adenoid cystic or mucoepidermoid)
- Peripheral neuropathy > Grade 2.
Show all 11Show fewer
- Serious non-malignant disease (e.g. congestive heart failure, uncontrolled atrial fibrillation, active hepatitis, renal failure or renal transplant).
- Scleroderma or active connective disorder (Lupus)
- Allergy to celecoxib, sulfonamides, or other NSAIDS
- Any underlying psychological condition that would prohibit the understanding and rendering of informed consent.
- Major surgery < 3 weeks prior to study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
Official title: Radiosensitization With a COX-2 Inhibitor (Celecoxib), With Chemoradiation for Cancer of the Head and Neck
This is a single-institution, open-label, non-randomized phase IB/II trial of celecoxib administered concurrently with carboplatin, paclitaxel, and radiation therapy in patients with locally advanced or recurrent squamous cell carcinoma of the head and neck.
Read the detailed description
Treatment for this protocol consists of radiotherapy, 70.2Gy, at 1.8Gy qd, Monday through Friday.Celecoxib 400mg bid is taken during radiotherapy, starting 1 week before radiotherapy. Carboplatin IV, AUC 2.0, weekly for weeks 1 through 7,Paclitaxel 45 mg/m2, weekly for weeks 1 through 7, and Celecoxib 400mg bid, continuing after therapy for two years or until disease progression.
- Conditions
- Cancer
- Being tested
- celecoxib, Carboplatin, Paclitaxel, Radiation Therapy
- Keywords
- Radiosensitization, COX-2 inhibitor, Celecoxib, Head and Neck Cancer, Chemoradiation
- Medical subject headings
- Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
Also called Celebrex
400mg bid starting 1 week before radiotherapy and taken through radiotherapy.
CarboplatinDrug
Also called Paraplatin
IV, AUC 2.0, weekly for weeks 1 through 7
PaclitaxelDrug
Also called Taxol
IV 30 mg/m2, weekly for weeks 1 through 7
Radiation TherapyRadiation
70.2Gy, at 1.8Gy qd, Monday through Friday
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy | Experimental | Not described Receives: Drug: celecoxib; Drug: Carboplatin; Drug: Paclitaxel; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity of Celecoxib With Concurrent Weekly Chemotherapy and Radiotherapy in the Treatment of Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck.
Particpants experiencing Acute Toxicities > Grade 3
Measured: 2 years from radiation therapy
Response as Evaluated by Recurrence of Diseases
Evaluate the response to concurrent celecoxib, carboplatin, paclitaxel, and radiotherapy in the treatment of locally advanced SSC of the head and neck. Response is determined by local control only, local and distant metastasis, distant metastasis only, second primary, and surgical salvage.
Measured: 2 years from end of treatment (Radiation therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startSep 2002
- Primary completionDec 2007
- Study completionMar 2012
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 (59)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Pharmacia
- Responsible party
- Principal investigator, Sharon Spencer, MD,, University of Alabama at Birmingham
- Investigators
- Sharon Spencer, M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581971
- Sponsor's protocol ID
- F020703003
- Other IDs
- Link No: 000276825
- Acronym
- RAD0201
- Status last verified
- Mar 2013
- First submitted
- 20 Dec 2007
- Last updated
- 25 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Aisner J, Sinibaldi V, Eisenberger M. Carboplatin in the treatment of squamous cell head and neck cancers. Semin Oncol. 1992 Feb;19(1 Suppl 2):60-5.
PubMed 1411628Altorki NK, Keresztes RS, Port JL, Libby DM, Korst RJ, Flieder DB, Ferrara CA, Yankelevitz DF, Subbaramaiah K, Pasmantier MW, Dannenberg AJ. Celecoxib, a selective cyclo-oxygenase-2 inhibitor, enhances the response to preoperative paclitaxel and carboplatin in early-stage non-small-cell lung cancer. J Clin Oncol. 2003 Jul 15;21(14):2645-50. doi: 10.1200/JCO.2003.07.127.
PubMed 12860939Bourhis J, Calais G, Eschwege F. [Chemoradiotherapy of carcinomas of the upper aerodigestive tract]. Cancer Radiother. 1998 Dec;2(6):679-88. doi: 10.1016/s1278-3218(99)80008-0. French.
PubMed 9922773Bourhis J, Eschwege F. Radiotherapy-chemotherapy combinations in head and neck squamous cell carcinoma: overview of randomized trials. Anticancer Res. 1996 Jul-Aug;16(4C):2397-402. No abstract available.
PubMed 8816841Brizel DM, Albers ME, Fisher SR, Scher RL, Richtsmeier WJ, Hars V, George SL, Huang AT, Prosnitz LR. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Engl J Med. 1998 Jun 18;338(25):1798-804. doi: 10.1056/NEJM199806183382503.
PubMed 9632446Chan G, Boyle JO, Yang EK, Zhang F, Sacks PG, Shah JP, Edelstein D, Soslow RA, Koki AT, Woerner BM, Masferrer JL, Dannenberg AJ. Cyclooxygenase-2 expression is up-regulated in squamous cell carcinoma of the head and neck. Cancer Res. 1999 Mar 1;59(5):991-4.
PubMed 10070952Choy H, Devore RF 3rd, Hande KR, Porter LL, Rosenblatt P, Yunus F, Schlabach L, Smith C, Shyr Y, Johnson DH. A phase II study of paclitaxel, carboplatin, and hyperfractionated radiation therapy for locally advanced inoperable non-small-cell lung cancer (a Vanderbilt Cancer Center Affiliate Network Study). Int J Radiat Oncol Biol Phys. 2000 Jul 1;47(4):931-7. doi: 10.1016/s0360-3016(00)00420-x.
PubMed 10863062Choy H, DeVore RF 3rd, Hande KR, Porter LL, Rosenblatt P, Yunus F, Schlabach L, Smith C, Shyr Y, LaPorte K, Johnson DH. Preliminary analysis of a phase II study of paclitaxel, carboplatin, and hyperfractionated radiation therapy for locally advanced inoperable non-small cell lung cancer. Semin Oncol. 1997 Aug;24(4 Suppl 12):S12-21-S12-26.
PubMed 9331115Eisbruch A, Lyden T, Bradford CR, Dawson LA, Haxer MJ, Miller AE, Teknos TN, Chepeha DB, Hogikyan ND, Terrell JE, Wolf GT. Objective assessment of swallowing dysfunction and aspiration after radiation concurrent with chemotherapy for head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):23-8. doi: 10.1016/s0360-3016(02)02712-8.
PubMed 12007937Eisenberger M, Hornedo J, Silva H, Donehower R, Spaulding M, Van Echo D. Carboplatin (NSC-241-240): an active platinum analog for the treatment of squamous-cell carcinoma of the head and neck. J Clin Oncol. 1986 Oct;4(10):1506-9. doi: 10.1200/JCO.1986.4.10.1506.
PubMed 3531424Eisenberger M, Jacobs M. Simultaneous treatment with single-agent chemotherapy and radiation for locally advanced cancer of the head and neck. Semin Oncol. 1992 Aug;19(4 Suppl 11):41-6.
PubMed 1509280Forastiere AA. Paclitaxel (Taxol) for the treatment of head and neck cancer. Semin Oncol. 1994 Oct;21(5 Suppl 8):49-52.
PubMed 7939763Forastiere AA. Taxoids in head and neck cancer: the American approach. Acta Otorhinolaryngol Belg. 1999;53(3):253-7.
PubMed 10635404Frost AR, Sparks D, Grizzle WE. Methods of antigen recovery vary in their usefulness in unmasking specific antigens in immunohistochemistry. Appl Immunohistochem Mol Morphol. 2000 Sep;8(3):236-43. doi: 10.1097/00129039-200009000-00011.
PubMed 10981877Fu KK, Pajak TF, Trotti A, Jones CU, Spencer SA, Phillips TL, Garden AS, Ridge JA, Cooper JS, Ang KK. A Radiation Therapy Oncology Group (RTOG) phase III randomized study to compare hyperfractionation and two variants of accelerated fractionation to standard fractionation radiotherapy for head and neck squamous cell carcinomas: first report of RTOG 9003. Int J Radiat Oncol Biol Phys. 2000 Aug 1;48(1):7-16. doi: 10.1016/s0360-3016(00)00663-5.
PubMed 10924966
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiosensitization With a COX-2 Inhibitor (Celecoxib), With Chemoradiation for Cancer of the Head and Neck
- ClinicalTrials.gov ID
- NCT00581971
- Acronym / sponsor ID
- RAD0201 / F020703003
- Conditions
- Cancer
- Keywords
- Radiosensitization, COX-2 inhibitor, Celecoxib, Head and Neck Cancer, Chemoradiation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Pharmacia
- Study start
- Sep 2002
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Posted 25 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-institution, open-label, non-randomized phase IB/II trial of celecoxib administered concurrently with carboplatin, paclitaxel, and radiation therapy in patients with locally advanced or recurrent squamous cell carcinoma of the head and neck.
Detailed description
Treatment for this protocol consists of radiotherapy, 70.2Gy, at 1.8Gy qd, Monday through Friday.Celecoxib 400mg bid is taken during radiotherapy, starting 1 week before radiotherapy. Carboplatin IV, AUC 2.0, weekly for weeks 1 through 7,Paclitaxel 45 mg/m2, weekly for weeks 1 through 7, and Celecoxib 400mg bid, continuing after therapy for two years or until disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy | Experimental | Drug: celecoxib, Drug: Carboplatin, Drug: Paclitaxel, Radiation: Radiation Therapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically proven primary squamous cell carcinoma arising in the oropharynx, oral cavity, hypopharynx, or larynx. Patients with recurrences after primary surgery (with no history of radiotherapy or chemotherapy) are also eligible.
- The patient has stage III or IV disease, T3 or higher, or N2 or higher, nonmetastatic. Recurrent need not satisfy these staging requirements on restating, but patients must be nonmetastatic, and either be unresectable, medically inoperable, or refuse further surgery.
- Performance status < 2 (ECOG scale) with a life expectancy of > 12 months.
- Age > 19 years.
- The patient is medically fit to tolerate a course of definitive radiation therapy.
Key exclusion criteria (11 listed)
- The patient has received radiation therapy previously to the head and neck. Previous radiotherapy for skin cancers of the head and neck are permitted if the fields do not overlap.
- The patient has received prior chemotherapy for head and neck cancer.
- The patient is pregnant or lactating.
- Squamous cell carcinoma arising in the nasopharynx, sinuses, salivary glands, or the primary is unknown.
- Non-squamous histologies (such as adenoid cystic or mucoepidermoid)
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: Celebrex400mg bid starting 1 week before radiotherapy and taken through radiotherapy. | Drug | Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy |
| CarboplatinAlso: ParaplatinIV, AUC 2.0, weekly for weeks 1 through 7 | Drug | Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy |
| PaclitaxelAlso: TaxolIV 30 mg/m2, weekly for weeks 1 through 7 | Drug | Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy |
| Radiation Therapy70.2Gy, at 1.8Gy qd, Monday through Friday | Radiation | Celecoxib+Carboplatin/Paclitaxel+Radiation Therapy |
Primary outcome
Toxicity of Celecoxib With Concurrent Weekly Chemotherapy and Radiotherapy in the Treatment of Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck.
Time frame: 2 years from radiation therapy
Particpants experiencing Acute Toxicities > Grade 3
Response as Evaluated by Recurrence of Diseases
Time frame: 2 years from end of treatment (Radiation therapy)
Evaluate the response to concurrent celecoxib, carboplatin, paclitaxel, and radiotherapy in the treatment of locally advanced SSC of the head and neck. Response is determined by local control only, local and distant metastasis, distant metastasis only, second primary, and surgical salvage.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1411628Aisner J, Sinibaldi V, Eisenberger M. Carboplatin in the treatment of squamous cell head and neck cancers. Semin Oncol. 1992 Feb;19(1 Suppl 2):60-5.
- Background: PubMed 12860939Altorki NK, Keresztes RS, Port JL, Libby DM, Korst RJ, Flieder DB, Ferrara CA, Yankelevitz DF, Subbaramaiah K, Pasmantier MW, Dannenberg AJ. Celecoxib, a selective cyclo-oxygenase-2 inhibitor, enhances the response to preoperative paclitaxel and carboplatin in early-stage non-small-cell lung cancer. J Clin Oncol. 2003 Jul 15;21(14):2645-50. doi: 10.1200/JCO.2003.07.127.
- Background: PubMed 9922773Bourhis J, Calais G, Eschwege F. [Chemoradiotherapy of carcinomas of the upper aerodigestive tract]. Cancer Radiother. 1998 Dec;2(6):679-88. doi: 10.1016/s1278-3218(99)80008-0. French.
- Background: PubMed 8816841Bourhis J, Eschwege F. Radiotherapy-chemotherapy combinations in head and neck squamous cell carcinoma: overview of randomized trials. Anticancer Res. 1996 Jul-Aug;16(4C):2397-402. No abstract available.
- Background: PubMed 9632446Brizel DM, Albers ME, Fisher SR, Scher RL, Richtsmeier WJ, Hars V, George SL, Huang AT, Prosnitz LR. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Engl J Med. 1998 Jun 18;338(25):1798-804. doi: 10.1056/NEJM199806183382503.
- Background: PubMed 10070952Chan G, Boyle JO, Yang EK, Zhang F, Sacks PG, Shah JP, Edelstein D, Soslow RA, Koki AT, Woerner BM, Masferrer JL, Dannenberg AJ. Cyclooxygenase-2 expression is up-regulated in squamous cell carcinoma of the head and neck. Cancer Res. 1999 Mar 1;59(5):991-4.
- Background: PubMed 10863062Choy H, Devore RF 3rd, Hande KR, Porter LL, Rosenblatt P, Yunus F, Schlabach L, Smith C, Shyr Y, Johnson DH. A phase II study of paclitaxel, carboplatin, and hyperfractionated radiation therapy for locally advanced inoperable non-small-cell lung cancer (a Vanderbilt Cancer Center Affiliate Network Study). Int J Radiat Oncol Biol Phys. 2000 Jul 1;47(4):931-7. doi: 10.1016/s0360-3016(00)00420-x.
- Background: PubMed 9331115Choy H, DeVore RF 3rd, Hande KR, Porter LL, Rosenblatt P, Yunus F, Schlabach L, Smith C, Shyr Y, LaPorte K, Johnson DH. Preliminary analysis of a phase II study of paclitaxel, carboplatin, and hyperfractionated radiation therapy for locally advanced inoperable non-small cell lung cancer. Semin Oncol. 1997 Aug;24(4 Suppl 12):S12-21-S12-26.
- Background: PubMed 12007937Eisbruch A, Lyden T, Bradford CR, Dawson LA, Haxer MJ, Miller AE, Teknos TN, Chepeha DB, Hogikyan ND, Terrell JE, Wolf GT. Objective assessment of swallowing dysfunction and aspiration after radiation concurrent with chemotherapy for head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):23-8. doi: 10.1016/s0360-3016(02)02712-8.
- Background: PubMed 3531424Eisenberger M, Hornedo J, Silva H, Donehower R, Spaulding M, Van Echo D. Carboplatin (NSC-241-240): an active platinum analog for the treatment of squamous-cell carcinoma of the head and neck. J Clin Oncol. 1986 Oct;4(10):1506-9. doi: 10.1200/JCO.1986.4.10.1506.
- Background: PubMed 1509280Eisenberger M, Jacobs M. Simultaneous treatment with single-agent chemotherapy and radiation for locally advanced cancer of the head and neck. Semin Oncol. 1992 Aug;19(4 Suppl 11):41-6.
- Background: PubMed 7939763Forastiere AA. Paclitaxel (Taxol) for the treatment of head and neck cancer. Semin Oncol. 1994 Oct;21(5 Suppl 8):49-52.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian 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.
Sharon Spencer, M.D. principal investigator
University of Alabama at Birmingham
1 site 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, Carboplatin and Paclitaxel in people with Cancer, run by University of Alabama at Birmingham at 1 site 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?
The sponsor lists 14 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 25 Apr 2013. 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 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 25 Apr 2013). 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?
Toxicity of Celecoxib With Concurrent Weekly Chemotherapy and Radiotherapy in the Treatment of Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck. (time frame: 2 years from radiation therapy). 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 NCT00581971, which also lists 59 linked publications.
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 25 Apr 2013.