Clinical Trial: Endostar Combination With Chemotherapy for the Metastatic Nasopharyngeal Carcinoma

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Phase II Clinical Study of Endostar Combination With Chemotherapy in the Metastatic Nasopharyngeal Carcinoma

Brief Summary: The investigators designed this study to evaluate the efficiency and the acute toxicities of recombinant human endostatin (endostar) combined with chemotherapy in the metastatic nasopharyngeal carcinoma (NPC).

Detailed Summary: To evaluate the progression free survival (PFS), overall survival (OS), Acute adverse reaction of recombinant human endostatin (endostar) combined with chemotherapy to the metastatic nasopharyngeal carcinoma (NPC).
Sponsor: Zhejiang Cancer Hospital

Current Primary Outcome: progress free survival(PFS) [ Time Frame: 1 year and 2years ]

PFS means assignament to the date of any local or distant progress of the disease useing Kaplan-Meier caculate the progress free survival rates


Original Primary Outcome: 1-year progress free survival(PFS) [ Time Frame: 1 year after the inception assignment ]

PFS means assignament to the date of any local or distant progress of the disease useing Kaplan-Meier caculate the progress free survival rates


Current Secondary Outcome:

  • overall survival(OS) [ Time Frame: baseline to date of death from any cause ]
    the overall survival denote to assignment to date of death from any cause. Using Kaplan-Meier to caculate the 1-year ,2-year,3-year overall survival rate
  • Adverse events [ Time Frame: participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 1 year ]
    observe and record the toxicity profile(incluing but not limit to mocositis,liver and kidney function,et al.)according NCI-CTCAE(3rd edtion) during the chemotherapy,Targeted therapy and follow-up


Original Secondary Outcome:

  • overall survival(OS) [ Time Frame: 1 year ,2 years and 3 years after the inception of the assignment ]
    the overall survival denote to assignment to date of death from any cause. Using Kaplan-Meier to caculate the 1-year ,2-year,3-year overall survival rate
  • Adverse events [ Time Frame: participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 1 year ]
    observe and record the toxicity profile(incluing but not limit to mocositis,liver and kidney function,et al.)according NCI-CTCAE(3rd edtion) during the chemotherapy,Targeted therapy and follow-up


Information By: Zhejiang Cancer Hospital

Dates:
Date Received: May 28, 2012
Date Started: May 2012
Date Completion: May 2014
Last Updated: February 16, 2014
Last Verified: April 2013