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Endostatin in Combination With Chemotherapy for Metastatic Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01915134
Recruitment Status : Unknown
Verified July 2013 by Zhejiang Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : August 2, 2013
Last Update Posted : January 1, 2015
Sponsor:
Collaborators:
Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sir Run Run Shaw Hospital
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Effects of Chemotherapy Stage IVC Nasopharyngeal Carcinoma Drug: Recombinant Human Endostatin plus gemcitabine and cisplatin Drug: Gemcitabine and cisplatin Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 362 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2013
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: EGP group
the group of participants who undergoing Recombinant Human Endostatin plus Gemcitabine and cisplatin chemotherapy
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.
Other Name: Experimental: EGP group

Active Comparator: GP group
the group of participants who undergoing only Gemcitabine and cisplatin chemotherapy
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.
Other Name: No Intervention: GP group




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915134


Contacts
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Contact: Xiaozhong Chen 86-571-88122098 cxzfyun@sina.com
Contact: Bin Li 86-571-88122091 libindoctor@163.com

Locations
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China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Bin Li    86-571-88122091    libindoctor@163.com   
Contact: Xinglai Feng    86-571-88122092    fengxinglai@hotmail.com   
Principal Investigator: Bin Li         
Sponsors and Collaborators
Zhejiang Cancer Hospital
Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sir Run Run Shaw Hospital
Investigators
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Principal Investigator: Xiaozhong Chen Zhejiang Cancer Hospital
Principal Investigator: Xiaozhong Chen Zhejiang Cancer Hospital Hangzhou, Zhejiang, China 310022
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Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01915134    
Other Study ID Numbers: ZhejaingCH-npc-03
First Posted: August 2, 2013    Key Record Dates
Last Update Posted: January 1, 2015
Last Verified: July 2013
Keywords provided by Zhejiang Cancer Hospital:
nasopharyngeal carcinoma
Recombinant Human Endostatin
chemotherapy
gemcitabine and cisplatin
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Gemcitabine
Cisplatin
Endostatins
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances