Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of COX-2 Inhibitor on Radiosensitivity in Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02537925
Recruitment Status : Unknown
Verified August 2015 by Changjie Huang, Nanning Second People's Hospital.
Recruitment status was:  Recruiting
First Posted : September 2, 2015
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Changjie Huang, Nanning Second People's Hospital

Tracking Information
First Submitted Date  ICMJE May 17, 2015
First Posted Date  ICMJE September 2, 2015
Last Update Posted Date September 2, 2015
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
  • 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. ]
    Overall survival (OS) is defined as the time between treatment initiation and the patient death.
  • 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 ]
    Progression free survival (PFS) is defined as the time between treatment initiation and the first evidence of cancer progression or death from any cause.
  • 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 ]
    Distant metastasis failure-free survival (DMFS) is defined as the time between treatment initiation and the occurrence of distant metastasis.
  • 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. ]
    Locoregional failure-free survival (LFFS) is defined as the time between treatment initiation and the relapse of a local or nodal tumor.
  • 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. ]
    The Treatment-Related Adverse Events are assessed by the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0.
  • Age will be recorded when the therapy starts [ Time Frame: Patients are asked to provide the birthday before the start of therapy ]
    Age is defined as the time between the birthday and treatment initiation.
  • 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 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of COX-2 Inhibitor on Radiosensitivity in Nasopharyngeal Carcinoma
Official Title  ICMJE The Effect of Celecoxib on Concurrent Chemoradiation With Weekly Nedaplatin in Nasopharyngeal Carcinoma
Brief 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.
Detailed Description
  1. 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.

  2. 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.

  3. 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Nasopharyngeal Carcinoma
Intervention  ICMJE
  • Drug: Celecoxib
    Celecoxib 200mg bid po, to the end of concurrent radiotherapy
    Other Name: COX-2 inhibitor
  • Drug: Nedaplatin
    40 mg/m2, IV (in the vein) on day 1 of each 7 day cycle. Number of Cycles: to the end of concurrent radiotherapy
  • Radiation: Concurrent Radiotherapy
    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).
    Other Name: standard radiotherapy schedule
Study Arms  ICMJE
  • Active Comparator: concurrent_radiochemotherapy
    Concurrent radiotherapy with Nedaplatin 40mg/m2/week through intravenous infusion.
    Interventions:
    • Drug: Nedaplatin
    • Radiation: Concurrent Radiotherapy
  • Experimental: celecoxib_radiochemotherapy
    Celecoxib 200mg bid po; Concurrent radiotherapy with Nedaplatin 40mg/m2/week through intravenous infusion.
    Interventions:
    • Drug: Celecoxib
    • Drug: Nedaplatin
    • Radiation: Concurrent Radiotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 28, 2015)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02537925
Other Study ID Numbers  ICMJE NaningSPH_2014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Changjie Huang, Nanning Second People's Hospital
Study Sponsor  ICMJE Changjie Huang
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Changjie Huang The third Affiliated Hospital of Guangxi Medical University
PRS Account Nanning Second People's Hospital
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP