Endostatin in Combination With Chemotherapy for Metastatic Nasopharyngeal Carcinoma

Effects of Chemotherapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01915134
• Other study ID #: ZhejaingCH-npc-03
• Status: Recruiting
• Phase: Phase 3
• First received: July 21, 2013
• Last updated: December 30, 2014
• Start date: August 2013
• Est. completion date: December 2016

Study information

• Verified date: July 2013
• Source: Zhejiang Cancer Hospital
• Contact: Xiaozhong Chen
• Phone: 86-571-88122098
• Email: cxzfyun[@]sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 362
• Est. completion date: December 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Effects of Chemotherapy
• Nasopharyngeal Neoplasms
• Stage IVC Nasopharyngeal Carcinoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (4)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital	Second Affiliated Hospital, School of Medicine, Zhejiang University, Sir Run Run Shaw Hospital, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The quality of life assessment	According to the most commonly used questionnaire EORTC QLQ C30 and H&N35 35 for evaluation	participants will be followed for the duration of hospital stay,an expected average of 100 days and every 6 months thereafter for 3 years	No
Primary	progress free survival(PFS)	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.	2years after the inception assignment	No
Secondary	overall survival(OS)	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.	1 year ,2 years and 3 years after the inception of the assignment	No
Secondary	Adverse events	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.	participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 3 years	Yes