Endostatin in Combination With Chemotherapy for Metastatic Nasopharyngeal Carcinoma
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|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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||362 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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
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
|Contact: Xiaozhong Chenemail@example.com|
|Contact: Bin Lifirstname.lastname@example.org|
|Principal Investigator:||Xiaozhong Chen||Zhejiang Cancer Hospital|
|Principal Investigator:||Xiaozhong Chen||Zhejiang Cancer Hospital Hangzhou, Zhejiang, China 310022|