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Endostatin in Combination With Chemotherapy for Metastatic Nasopharyngeal Carcinoma

Primary Purpose

Effects of Chemotherapy, Stage IVC Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Recombinant Human Endostatin plus gemcitabine and cisplatin
Gemcitabine and cisplatin
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Effects of Chemotherapy focused on measuring nasopharyngeal carcinoma, Recombinant Human Endostatin, chemotherapy, gemcitabine and cisplatin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EGP group

GP group

Arm Description

the group of participants who undergoing Recombinant Human Endostatin plus Gemcitabine and cisplatin chemotherapy

the group of participants who undergoing only Gemcitabine and cisplatin chemotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 21, 2013
Last Updated
December 30, 2014
Sponsor
Zhejiang Cancer Hospital
Collaborators
Zhejiang University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Sir Run Run Shaw Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01915134
Brief Title
Endostatin in Combination With Chemotherapy for Metastatic Nasopharyngeal Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
Collaborators
Zhejiang University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Sir Run Run Shaw Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effects of Chemotherapy, Stage IVC Nasopharyngeal Carcinoma
Keywords
nasopharyngeal carcinoma, Recombinant Human Endostatin, chemotherapy, gemcitabine and cisplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
362 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EGP group
Arm Type
Experimental
Arm Description
the group of participants who undergoing Recombinant Human Endostatin plus Gemcitabine and cisplatin chemotherapy
Arm Title
GP group
Arm Type
Active Comparator
Arm Description
the group of participants who undergoing only Gemcitabine and cisplatin chemotherapy
Intervention Type
Drug
Intervention Name(s)
Recombinant Human Endostatin plus gemcitabine and cisplatin
Other Intervention Name(s)
Experimental: EGP group
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine and cisplatin
Other Intervention Name(s)
No Intervention: GP group
Intervention Description
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.
Primary Outcome Measure Information:
Title
progress free survival(PFS)
Description
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.
Time Frame
2years after the inception assignment
Secondary Outcome Measure Information:
Title
overall survival(OS)
Description
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.
Time Frame
1 year ,2 years and 3 years after the inception of the assignment
Title
Adverse events
Description
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.
Time Frame
participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 3 years
Other Pre-specified Outcome Measures:
Title
The quality of life assessment
Description
According to the most commonly used questionnaire EORTC QLQ C30 and H&N35 35 for evaluation
Time Frame
participants will be followed for the duration of hospital stay,an expected average of 100 days and every 6 months thereafter for 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaozhong Chen
Phone
86-571-88122098
Email
cxzfyun@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Li
Phone
86-571-88122091
Email
libindoctor@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaozhong Chen
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaozhong Chen
Organizational Affiliation
Zhejiang Cancer Hospital Hangzhou, Zhejiang, China 310022
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Li
Phone
86-571-88122091
Email
libindoctor@163.com
First Name & Middle Initial & Last Name & Degree
Xinglai Feng
Phone
86-571-88122092
Email
fengxinglai@hotmail.com
First Name & Middle Initial & Last Name & Degree
Bin Li

12. IPD Sharing Statement

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Endostatin in Combination With Chemotherapy for Metastatic Nasopharyngeal Carcinoma

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