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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary:

  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,
    Sponsor: Changjie Huang

    Current 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.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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: Same as current

    Information By: Nanning Second People's Hospital

    Dates:
    Date Received: May 17, 2015
    Date Started: January 2014
    Date Completion: December 2016
    Last Updated: August 28, 2015
    Last Verified: August 2015