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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 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

Sorafenib plus Cisplatin and 5-fluorouracil

Li Zhang, MD

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 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)

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 Metastatic Nasopharyngeal Carcinoma (NPC)

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

The disease control rate (DCR) was 90.8%.

Sun Yat-sen University

Profressor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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)	NCT00747799	Nasopharyngeal ...	Sorafenib plus ...	18 Years -	Sun Yat-sen University
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)	NCT00747799	Nasopharyngeal ...	Sorafenib plus ...	18 Years -	Sun Yat-sen University

Spots Global Cancer Trial Database for recurrent or metastatic nasopharyngeal neoplasms