NCT01915134

Endostatin in Combination With Chemotherapy for Metastatic Nasopharyngeal Carcinoma

A Prospective,Randomized,Controlled,Multicenter,Phase III Study of Stage Ⅲ Study of Gemcitabine Plus Cisplatin With or Without Endostatin to the Metastatic Nasopharyngeal Carcinoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 362 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 description

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).

Conditions

• Effects of Chemotherapy
• Stage IVC Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Recombinant Human Endostatin plus gemcitabine and cisplatin	target therapy plus chemotherapy:4-6 cycles of Recombinant Human Endostatin plus gemcitabine and cisplatin:Endostatin：7.5mg/m2/d,d1-14,concomitant with chemotherapy for 4-6 cycles.Gemcitabine and cisplatin:4-6 cycles of GP chemotherapy with gemcitabine 1000mg/m2,d1,8,cisplatin80mg/m2,d1.Chemotherapy will be given once every three weeks.
DRUG	Gemcitabine and cisplatin	only chemotherapy：Gemcitabine and cisplatin:4-6 cycles of GP chemotherapy with gemcitabine 1000mg/m2,d1,8,cisplatin80mg/m2,d1.Chemotherapy will be given once every three weeks.

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-01-01
• Completion: 2016-12-01
• First posted: 2013-08-02
• Last updated: 2015-01-01

Locations

1 site across 1 country: China