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 ]

In the ITT analysis(n=54), the ORR reached 77.8%: one patient (1.9%) experienced CR; 41 (75.9%), PR.


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 ]

The disease control rate (DCR) was 90.8%.


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