Clinical Trial: Study of Combination of Sorafenib With Cisplatin and 5-fluorouracil as First-line Treatment of Recurrence After Radiotherapy Patients Who Failed With Radiotherapy in Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Study of Combination of Sorafenib With Cisplatin and 5-fluorouracil as First-line Treatment of Recurrence After Radiotherapy Patients Who Are Failure of Radiotherapy in Recurrent or Metastati
Brief Summary: This study is a phase II clinical study. Recurrence after radiotherapy patients who are failure of radiotherapy in recurrent or metastatic nasopharyngeal carcinoma (NPC) were treated by cisplatin and 5-fluorouracil with Sorafenib as first-line treatment. The objective response(complete response (CR) + partial response (PR)), Disease Control Rate , safety profile, tolerability will be evaluated according to World Health Organization (WHO) criteria.
Detailed Summary:
Sponsor: Sun Yat-sen University
Current Primary Outcome: Objective response rate (CR+PR) [ Time Frame: January 2009 to May 2011 ]
Original Primary Outcome: Disease control rate (CR+PR+SD) [ Time Frame: Aug 2010 ]
Current Secondary Outcome: Disease control rate [ Time Frame: January 2009 to May 2011 ]
Original Secondary Outcome: Objective response [ Time Frame: Aug 2010 ]
Information By: Sun Yat-sen University
Dates:
Date Received: September 4, 2008
Date Started: January 2009
Date Completion:
Last Updated: December 8, 2013
Last Verified: November 2011