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
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 362
- Locations
- 1
- Primary Endpoint
- progress free survival(PFS)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
EGP group
the group of participants who undergoing Recombinant Human Endostatin plus Gemcitabine and cisplatin chemotherapy
Intervention: Recombinant Human Endostatin plus gemcitabine and cisplatin (Drug)
GP group
the group of participants who undergoing only Gemcitabine and cisplatin chemotherapy
Intervention: Gemcitabine and cisplatin (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- overall survival(OS)(1 year ,2 years and 3 years after the inception of the assignment)
- Adverse events(participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 3 years)