Effects of Chemotherapy, Stage IVC Nasopharyngeal Carcinoma
Conditions
Keywords
nasopharyngeal carcinoma, Recombinant Human Endostatin, chemotherapy, gemcitabine and cisplatin
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).
Interventions
DRUGRecombinant 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.
DRUGGemcitabine 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.
Sponsors
Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sir Run Run Shaw Hospital
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progress free survival(PFS) | 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
| Measure | Time frame | Description |
|---|---|---|
| overall survival(OS) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| The quality of life assessment | 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 |
Countries
China
Contacts
Primary ContactXiaozhong Chen
Backup ContactBin Li
Outcome results
None listed