Endostatin in Combination With Chemotherapy for Metastatic Nasopharyngeal Carcinoma

Phase 3

• Conditions: Stage IVC Nasopharyngeal Carcinoma; Effects of Chemotherapy
• Interventions: Drug: Gemcitabine and cisplatin; Drug: Recombinant Human Endostatin plus gemcitabine and cisplatin

• Registration Number: NCT01915134
• Lead Sponsor: Zhejiang Cancer Hospital

Brief 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).

Study Timeline

• Status Verified: 2013-07
• Study First Submitted: 2013-07-21
• Study First Submitted QC: 2013-07-31
• Study Start: 2013-08
• Study First Posted: 2013-08-02
• Last Update Submitted: 2014-12-30
• Last Update Posted: 2015-01-01
• Primary Completion: 2016-01
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 362

Inclusion Criteria

• metastatic nasopharyngeal carcinoma 6 months after first treatment,never receive any anticancer treatment except local radiotherapy to the bone metastasis，at least one measurable metastatic lesions，ECOG PS 0-1，Electrocardiogram (ecg) no special abnormal，comply with the test requirements, cooperate with regular follow-up.

Exclusion Criteria

• To give local treatment,clinical severe infection(>grade 2),with the central nervous system metastases,ECOG PS≥2,patients with pregnancy or breastfeeding,has a history of peripheral nerve disease,concomitant with other serious diseases,ever or concomitant with other serious diseases except for Cervical carcinoma in situ,cure of basal cell carcinoma,bladder surface tumor,any cancer 3 years after curation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GP group	Gemcitabine and cisplatin	the group of participants who undergoing only Gemcitabine and cisplatin chemotherapy
EGP group	Recombinant Human Endostatin plus gemcitabine and cisplatin	the group of participants who undergoing Recombinant Human Endostatin plus Gemcitabine and cisplatin chemotherapy

Primary Outcome Measures

Name	Time	Method
progress free survival(PFS)	2years after the inception assignment	PFS means assignment to the date of any local or distant progress of the disease using Kaplan-Meier calculate the progress free survival rates,and find out is there significant difference between these two groups.

Secondary Outcome Measures

Name	Time	Method
overall survival(OS)	1 year ,2 years and 3 years after the inception of the assignment	the overall survival denote to assignment to date of death from any cause. Using Kaplan-Meier to calculate the 2-year ,3-year,5-year overall survival rate,and find is there any significant difference between these two groups.
Adverse events	participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 3 years	observe and record the toxicity profile(including but not limit to mucositis,liver and kidney function,et al.)according NCI-CTCAE(3rd edition) during the neoadjuvant chemotherapy ,chemoradiation and follow-up.

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China