Nasopharyngeal CarcinomaPhase 3NCT02537925
The Effect of COX-2 Inhibitor on Radiosensitivity in Nasopharyngeal Carcinoma
A Phase 3 study testing Celecoxib, Nedaplatin and Concurrent Radiotherapy in people with Nasopharyngeal Carcinoma, run by Changjie Huang at 1 site in China.
Trial summary
The purpose of this study is to determine whether celecoxib is effective in the treatment of nasopharyngeal carcinoma by concurrent chemoradiation with weekly nedaplatin. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Celecoxib, Nedaplatin and Concurrent Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2016
- Phase
- Phase 3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with NPC newly diagnosed by histopathology, and without radiotherapy or chemotherapy before the clinical trial
- Patients with measurable lesions by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- With the Eastern Cooperative Oncology Group Performance Status (ECOG PS) as 0-1 score
- Serum hemoglobin ≥10gm/dL, platelet ≥100000/μL, neutrophil granulocyte absolute counting is 1500/μL
- Serum creatinine ≤1.25 times of upper normal limit (UNL), creatinine clearance rate ≥ 60 ml/min
- Serum bilirubin ≤ 1.5times of UNL, serum aspartate aminotransferase (AST) or glutamic-oxaloacetic transaminase(GOT)≤ 2.5 times of UNL, serum alanine aminotransferase (ALT) or glutamic-pyruvic transaminase (GPT) ≤ 2.5 times of UNL, alkaline phosphatase≤5 times of UNL
- The estimate overall survival (OS)> 6 months
- With formal informed consent forms signed.
Who cannot join
- With symptomatic brain/bone metastases,
- With cognitive impairment or other malignancies
- With any contraindications for radiotherapy and chemotherapy (such as active phase of infection, myocardial infarction within 6 months, symptomatic heart disease, including unstable angina pectoris, congestive heart failure or uncontrolled arrhythmias, in current immunosuppressive therapy)
- Current pregnancy, lactating women or women with fertility but don't take contraceptive measures yet
- With severe bone marrow dysfunction
- With bleeding tendency
Show all 9Show fewer
- With abuse of drugs or alcohol addicts
- Who may have III-IV type of allergic reactions to any treatment in this study
- With termination of trial because of intolerable toxicity, other study drugs using during the clinical study, or unwilling to continue the treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The third Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Yan Mao, M.D., +8614795721791, zijujuan@163.com
About this study
Official title: The Effect of Celecoxib on Concurrent Chemoradiation With Weekly Nedaplatin in Nasopharyngeal Carcinoma
The purpose of this study is to determine whether celecoxib is effective in the treatment of nasopharyngeal carcinoma by concurrent chemoradiation with weekly nedaplatin.
Read the detailed description
- Study Patients: Patients are all recruited from the Third Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China. All the patients provide written informed consent before enrollment. All eligible patients received a pretreatment evaluation including complete history and physical examination, endoscopic biopsy, routine laboratory tests for hematologic, renal and hepatic function as well as a dental and nutritional evaluation prior to treatment. Radiological investigations consisted of computed tomography (CT) scan or magnetic MRI of the nasopharynx, chest radiography, ultrasound of the upper abdomen and bone scintigraphy. Pathologic confirmation of nasopharyngeal cancer (NPC) was performed and re-classified according to the world health organization (WHO) subtypes.
- Study design: A total of 120 NPC patients are randomly and equally divided into two groups: Nedaplatin alone concurrent radiotherapy, Celecoxib plus nedaplatin concurrent radiotherapy. The tumor response will be evaluated by magnetic resonance imaging (MRI) after 4 weeks. The tumor responses including Complete Response (CR), Partial Response (PR) , Stable Disease (SD) and Progressive Disease (PD) is defined according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0. The show term or long term toxicity will be evaluated according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0. All the NPC patients are requested to be followed up with an expected average of every 3 months after the therapy.The other clinical outcomes including the first evidence of cancer progression or death from any cause, the occurrence of distant metastasis, and the relapse of a local or nodal tumor will be evaluated as well. The follow-up will be up to 2018.
- Statistical Analysis:
Statistical Package for the Social Sciences (SPSS 13.0) is used to analyze the effect of celecoxib on the nedaplatin concurrent radiotherapy. Cox's regression model and Kaplan-Meier method is used to conduct survival analysis. Clinical outcomes including the tumor responses, 1-year/3-year/5-year overall survival (OS), progression free survival (PFS), distant metastasis failure-free survival (DMFS) and locoregional failure-free survival (LFFS) will be analyzed. The multivariate Cox's regression model is used to adjust the confounders, including age and body mass index. P value less than 0.05 will be considered to be statistically significant.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Celecoxib, Nedaplatin, Concurrent Radiotherapy
- Keywords
- COX-2 inhibitors, radiosensitivity, nasopharyngeal carcinoma
- Medical subject headings
- Nasopharyngeal Carcinoma
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
Celecoxib 200mg bid po, to the end of concurrent radiotherapy
NedaplatinDrug
40 mg/m2, IV (in the vein) on day 1 of each 7 day cycle. Number of Cycles: to the end of concurrent radiotherapy
Concurrent RadiotherapyRadiation
Also called standard radiotherapy schedule
The standard radiotherapy schedules were available as conventional radiotherapy and Intensity Modulated Radiotherapy (IMRT). The cumulative radiation dose was 68~74 Gy for primary tumor (2.0~2.3 Gy/f/day, 5 day/ week, /6~7 weeks), and 50~54 Gy for lymphatic positive area (1.8 ~ 2 Gy/f/day, 5 day/week, /5.0~5.5 weeks).
| Study group | Role | What they receive |
|---|---|---|
| concurrent_radiochemotherapy | Active comparator | Concurrent radiotherapy with Nedaplatin 40mg/m2/week through intravenous infusion. Receives: Drug: Nedaplatin; Radiation: Concurrent Radiotherapy |
| celecoxib_radiochemotherapy | Experimental | Celecoxib 200mg bid po; Concurrent radiotherapy with Nedaplatin 40mg/m2/week through intravenous infusion. Receives: Drug: Celecoxib; Drug: Nedaplatin; Radiation: Concurrent Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with different tumor response and short term toxicity will be recorded
The tumor responses including Complete Response (CR), Partial Response (PR) , Stable Disease (SD) and Progressive Disease (PD) were evaluated by MRI, according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0; Short term toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0.
Measured: Patients are asked to be followed within an expected average of 4 weeks after therapy
Secondary outcomes (7)
The date when each patient is dead will be recorded.
Overall survival (OS) is defined as the time between treatment initiation and the patient death.
Measured: Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the date of first documented death from any cause, assessed up to 36 months.
The date when each patient shows the first evidence of cancer progression or death from any cause will be recorded.
Progression free survival (PFS) is defined as the time between treatment initiation and the first evidence of cancer progression or death from any cause.
Measured: Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the date of first documented progression or date of death from any cause, whichever comes first, up to 36 months
The date when each patient presents the occurrence of distant metastasis will be recorded.
Distant metastasis failure-free survival (DMFS) is defined as the time between treatment initiation and the occurrence of distant metastasis.
Measured: Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the date of first documented occurrence of distant metastasis, assessed up to 36 months
The date when each patient presents the relapse of a local or nodal tumor will be recorded.
Locoregional failure-free survival (LFFS) is defined as the time between treatment initiation and the relapse of a local or nodal tumor.
Measured: Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the date of first documented relapse of a local or nodal tumor, whichever came first, assessed up to 36 months.
Long term toxicity will be recorded as the Number of Participants with Treatment-Related Adverse Events
The Treatment-Related Adverse Events are assessed by the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0.
Measured: Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the documented date of the Treatment-Related Adverse Events, whichever comes first, assessed up to 36 months.
Age will be recorded when the therapy starts
Age is defined as the time between the birthday and treatment initiation.
Measured: Patients are asked to provide the birthday before the start of therapy
Height in meters and weight in kilograms will be recorded when therapy starts
High and weight are measured in standing posture without shoes by trained nurses. Body mass index is calculated form weight in kilograms divided by height in meters squared.
Measured: Patients are asked to be measured the height and weight before the start of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changjie Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Changjie Huang, Nanning Second People's Hospital
- Investigators
- Changjie Huang, Principal investigator, The third Affiliated Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537925
- Sponsor's protocol ID
- NaningSPH_2014
- Status last verified
- Aug 2015
- First submitted
- 17 May 2015
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Soo RA, Wu J, Aggarwal A, Tao Q, Hsieh W, Putti T, Tan KB, Low JS, Lai YF, Mow B, Hsu S, Loh KS, Tan L, Tan P, Goh BC. Celecoxib reduces microvessel density in patients treated with nasopharyngeal carcinoma and induces changes in gene expression. Ann Oncol. 2006 Nov;17(11):1625-30. doi: 10.1093/annonc/mdl283. Epub 2006 Sep 28.
PubMed 17008411Mohammadianpanah M, Razmjou-Ghalaei S, Shafizad A, Ashouri-Taziani Y, Khademi B, Ahmadloo N, Ansari M, Omidvari S, Mosalaei A, Mosleh-Shirazi MA. Efficacy and safety of concurrent chemoradiation with weekly cisplatin +/- low-dose celecoxib in locally advanced undifferentiated nasopharyngeal carcinoma: a phase II-III clinical trial. J Cancer Res Ther. 2011 Oct-Dec;7(4):442-7. doi: 10.4103/0973-1482.92013.
PubMed 22269407
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Celecoxib on Concurrent Chemoradiation With Weekly Nedaplatin in Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT02537925
- Acronym / sponsor ID
- NaningSPH_2014
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- COX-2 inhibitors, radiosensitivity, nasopharyngeal carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Changjie HuangUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Sep 2015 (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 determine whether celecoxib is effective in the treatment of nasopharyngeal carcinoma by concurrent chemoradiation with weekly nedaplatin.
Detailed description
- Study Patients: Patients are all recruited from the Third Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China. All the patients provide written informed consent before enrollment. All eligible patients received a pretreatment evaluation including complete history and physical examination, endoscopic biopsy, routine laboratory tests for hematologic, renal and hepatic function as well as a dental and nutritional evaluation prior to treatment. Radiological investigations consisted of computed tomography (CT) scan or magnetic MRI of the nasopharynx, chest radiography, ultrasound of the upper abdomen and bone scintigraphy. Pathologic confirmation of nasopharyngeal cancer (NPC) was performed and re-classified according to the world health organization (WHO) subtypes.
- Study design: A total of 120 NPC patients are randomly and equally divided into two groups: Nedaplatin alone concurrent radiotherapy, Celecoxib plus nedaplatin concurrent radiotherapy. The tumor response will be evaluated by magnetic resonance imaging (MRI) after 4 weeks. The tumor responses including Complete Response (CR), Partial Response (PR) , Stable Disease (SD) and Progressive Disease (PD) is defined according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0. The show term or long term toxicity will be evaluated according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0. All the NPC patients are requested to be followed up with an expected average of every 3 months after the therapy.The other clinical outcomes including the first evidence of cancer progression or death from any cause, the occurrence of distant metastasis, and the relapse of a local or nodal tumor will be evaluated as well. The follow-up will be up to 2018.
- Statistical Analysis:
Statistical Package for the Social Sciences (SPSS 13.0) is used to analyze the effect of celecoxib on the nedaplatin concurrent radiotherapy. Cox's regression model and Kaplan-Meier method is used to conduct survival analysis. Clinical outcomes including the tumor responses, 1-year/3-year/5-year overall survival (OS), progression free survival (PFS), distant metastasis failure-free survival (DMFS) and locoregional failure-free survival (LFFS) will be analyzed. The multivariate Cox's regression model is used to adjust the confounders, including age and body mass index. P value less than 0.05 will be considered to be statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| concurrent_radiochemotherapy | Active comparator | Drug: Nedaplatin, Radiation: Concurrent RadiotherapyConcurrent radiotherapy with Nedaplatin 40mg/m2/week through intravenous infusion. |
| celecoxib_radiochemotherapy | Experimental | Drug: Celecoxib, Drug: Nedaplatin, Radiation: Concurrent RadiotherapyCelecoxib 200mg bid po; Concurrent radiotherapy with Nedaplatin 40mg/m2/week through intravenous infusion. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients with NPC newly diagnosed by histopathology, and without radiotherapy or chemotherapy before the clinical trial
- Patients with measurable lesions by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- With the Eastern Cooperative Oncology Group Performance Status (ECOG PS) as 0-1 score
- Serum hemoglobin ≥10gm/dL, platelet ≥100000/μL, neutrophil granulocyte absolute counting is 1500/μL
- Serum creatinine ≤1.25 times of upper normal limit (UNL), creatinine clearance rate ≥ 60 ml/min
Key exclusion criteria (9 listed)
- With symptomatic brain/bone metastases,
- With cognitive impairment or other malignancies
- With any contraindications for radiotherapy and chemotherapy (such as active phase of infection, myocardial infarction within 6 months, symptomatic heart disease, including unstable angina pectoris, congestive heart failure or uncontrolled arrhythmias, in current immunosuppressive therapy)
- Current pregnancy, lactating women or women with fertility but don't take contraceptive measures yet
- With severe bone marrow dysfunction
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 inhibitorCelecoxib 200mg bid po, to the end of concurrent radiotherapy | Drug | celecoxib_radiochemotherapy |
| Nedaplatin40 mg/m2, IV (in the vein) on day 1 of each 7 day cycle. Number of Cycles: to the end of concurrent radiotherapy | Drug | celecoxib_radiochemotherapy, concurrent_radiochemotherapy |
| Concurrent RadiotherapyAlso: standard radiotherapy scheduleThe standard radiotherapy schedules were available as conventional radiotherapy and Intensity Modulated Radiotherapy (IMRT). The cumulative radiation dose was 68~74 Gy for primary tumor (2.0~2.3 Gy/f/day, 5 day/ week, /6~7 weeks), and 50~54 Gy for lymphatic positive area (1.8 ~ 2 Gy/f/day, 5 day/week, /5.0~5.5 weeks). | Radiation | celecoxib_radiochemotherapy, concurrent_radiochemotherapy |
Primary outcome
Number of patients with different tumor response and short term toxicity will be recorded
Time frame: Patients are asked to be followed within an expected average of 4 weeks after therapy
The tumor responses including Complete Response (CR), Partial Response (PR) , Stable Disease (SD) and Progressive Disease (PD) were evaluated by MRI, according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0; Short term toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0.
7 secondary outcomes
The date when each patient is dead will be recorded.
Time frame: Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the date of first documented death from any cause, assessed up to 36 months.
The date when each patient shows the first evidence of cancer progression or death from any cause will be recorded.
Time frame: Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the date of first documented progression or date of death from any cause, whichever comes first, up to 36 months
The date when each patient presents the occurrence of distant metastasis will be recorded.
Time frame: Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the date of first documented occurrence of distant metastasis, assessed up to 36 months
The date when each patient presents the relapse of a local or nodal tumor will be recorded.
Time frame: Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the date of first documented relapse of a local or nodal tumor, whichever came first, assessed up to 36 months.
Long term toxicity will be recorded as the Number of Participants with Treatment-Related Adverse Events
Time frame: Patients will be asked to be followed in an expected average of every 3 months after therapy. From date of treatment initiation until the documented date of the Treatment-Related Adverse Events, whichever comes first, assessed up to 36 months.
Age will be recorded when the therapy starts
Time frame: Patients are asked to provide the birthday before the start of therapy
Height in meters and weight in kilograms will be recorded when therapy starts
Time frame: Patients are asked to be measured the height and weight before the start of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
- Background: PubMed 17008411Soo RA, Wu J, Aggarwal A, Tao Q, Hsieh W, Putti T, Tan KB, Low JS, Lai YF, Mow B, Hsu S, Loh KS, Tan L, Tan P, Goh BC. Celecoxib reduces microvessel density in patients treated with nasopharyngeal carcinoma and induces changes in gene expression. Ann Oncol. 2006 Nov;17(11):1625-30. doi: 10.1093/annonc/mdl283. Epub 2006 Sep 28.
- Background: PubMed 22269407Mohammadianpanah M, Razmjou-Ghalaei S, Shafizad A, Ashouri-Taziani Y, Khademi B, Ahmadloo N, Ansari M, Omidvari S, Mosalaei A, Mosleh-Shirazi MA. Efficacy and safety of concurrent chemoradiation with weekly cisplatin +/- low-dose celecoxib in locally advanced undifferentiated nasopharyngeal carcinoma: a phase II-III clinical trial. J Cancer Res Ther. 2011 Oct-Dec;7(4):442-7. doi: 10.4103/0973-1482.92013.
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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.
Changjie Huang principal investigator
The third Affiliated Hospital of Guangxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Celecoxib, Nedaplatin and Concurrent Radiotherapy in people with Nasopharyngeal Carcinoma, run by Changjie Huang at 1 site in China.
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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 2 Sep 2015. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Mao, M.D. (+8614795721791, zijujuan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with different tumor response and short term toxicity will be recorded (time frame: Patients are asked to be followed within an expected average of 4 weeks after therapy). 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 NCT02537925, which also lists 2 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 2 Sep 2015.