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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
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) * Sorafenib 400 mg bid per daily . Every 21-day cycles. * Cisplatin 80 mg/m2 day d1, every 21 days cycle. * 5-fluorouracil 1000 mg/m2 day CIV 4days, repeat 21-day cycles
Cancer Center of Sun-Yat Sen University
Guangzhou, Guangdong, China
Objective response rate (CR+PR)
In the ITT analysis(n=54), the ORR reached 77.8%: one patient (1.9%) experienced CR; 41 (75.9%), PR.
Time frame: January 2009 to May 2011
Disease control rate
The disease control rate (DCR) was 90.8%.
Time frame: January 2009 to May 2011
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