This is an open-label, uncontrolled, multicenter phase II clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cisplatin and 5-Fu combined with nimotuzumab in patients with untreated metastatic nasopharyngeal carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
DDP+5-Fu DDP 100 mg/m2 intravenous infusion in day1, 5-Fu 1000mg/m2/d continuous intravenous infusion on days 1 through 4, both drugs are given every 3 weeks. Nimotuzumab 200mg/d, intravenous infusion every week
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Objective response rate
To be determined by measurement of target lesions according to RECIST criteria
Time frame: study period of 19 Months
Progression free survival
Defined as the time in months from first dose of Nimotuzumab until PD is observed or death occurs due to any cause.
Time frame: 19 Months
Overall survival
Defined as the time in months from first dose of Nimotuzumab to the date of death is observed or to last follow-up visit.
Time frame: 19 Months
Quality of life
Using EORTC QLQ-C30(version 3.0) and EORTC QLQ-H\&N35(Version 1.0) to access the quality of life. Collecting data before treatment, 1 week after each 2 cycles of chemotherapy, 1 months after all treatment finished.
Time frame: 8 Months
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