- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01915134
Endostatin in Combination With Chemotherapy for Metastatic Nasopharyngeal Carcinoma
December 30, 2014 updated by: Zhejiang Cancer Hospital
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
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).
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
362
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaozhong Chen
- Phone Number: 86-571-88122098
- Email: cxzfyun@sina.com
Study Contact Backup
- Name: Bin Li
- Phone Number: 86-571-88122091
- Email: libindoctor@163.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310022
- Recruiting
- Zhejiang Cancer hospital
-
Principal Investigator:
- Bin Li
-
Contact:
- Bin Li
- Phone Number: 86-571-88122091
- Email: libindoctor@163.com
-
Contact:
- Xinglai Feng
- Phone Number: 86-571-88122092
- Email: fengxinglai@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EGP group
the group of participants who undergoing Recombinant Human Endostatin plus Gemcitabine and cisplatin chemotherapy
|
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.
Other Names:
|
Active Comparator: GP group
the group of participants who undergoing only Gemcitabine and cisplatin chemotherapy
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progress free survival(PFS)
Time Frame: 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.
|
2years after the inception assignment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival(OS)
Time Frame: 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.
|
1 year ,2 years and 3 years after the inception of the assignment
|
Adverse events
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
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The quality of life assessment
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Xiaozhong Chen, Zhejiang Cancer hospital
- Principal Investigator: Xiaozhong Chen, Zhejiang Cancer Hospital Hangzhou, Zhejiang, China 310022
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Anticipated)
January 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
July 21, 2013
First Submitted That Met QC Criteria
July 31, 2013
First Posted (Estimate)
August 2, 2013
Study Record Updates
Last Update Posted (Estimate)
January 1, 2015
Last Update Submitted That Met QC Criteria
December 30, 2014
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Gemcitabine
- Cisplatin
- Endostatins
Other Study ID Numbers
- ZhejaingCH-npc-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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