Clinical trial NCT01915134: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Effects of Chemotherapy
Stage IVC Nasopharyngeal Carcinoma
Keywords: nasopharyngeal carcinoma
Recombinant Human Endostatin
chemotherapy
gemcitabine and cisplatin
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Zhejiang University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Sir Run Run Shaw Hospital
First posted: 2013-08-02
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: progress free survival(PFS)
timeFrame: 2years after the inception assignment
Secondary outcomes:
measure: overall survival(OS)
timeFrame: 1 year ,2 years and 3 years after the inception of the assignment
measure: Adverse events
timeFrame: 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 outcomes:
measure: The quality of life assessment
timeFrame: participants will be followed for the duration of hospital stay,an expected average of 100 days and every 6 months thereafter for 3 years
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Xiaozhong Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Cancer Hospital Hangzhou, Zhejiang, China 310022
name: Xiaozhong Chen
role: PRINCIPAL_INVESTIGATOR
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