This is an open, multicenter phase Ⅱ clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cetuximab (C225) combined with IMRT + neoadjuvant chemotherapy in advanced T stage of nasopharyngeal carcinoma. Besides, to figure out the relationship between patient outcome and EGFR gene copy number, expression and mutation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
400mg/m2 intravenous infusion the week before radiotherapy, 250mg/m2 intravenous infusion weekly for 6 weeks during radiotherapy
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China
3 Month Complete Response Rate + Partial Response Rate
According to RECIST (Response Evaluation Criteria in Solid Tumors) criteria, Complete response was defined as disappearance of all target lesions, Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions.
Time frame: 3 Months
One-year locoregional control rate
locoregional control rate: from the time when finish treatment to persistence or recurrence in the nasopharyngeal and/or cervical region.
Time frame: 1 year
Three-year locoregional control rate
locoregional control rate: from the time when finish treatment to persistence or recurrence in the nasopharyngeal and/or cervical region.
Time frame: 3 years
One-year disease free survival rate
disease free survival rate: from the time when finish treatment to first failure at any site.
Time frame: 1 year
Three-year disease free survival rate
disease free survival rate: from the time when finish treatment to first failure at any site.
Time frame: 3 years
One-year overall survival rate
overall survival rate: from the time when finish treatment to death of any cause.
Time frame: 1 year
Three-year overall survival rate
overall survival rate: from the time when finish treatment to death of any cause.
Time frame: 3 years
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The relationship between 3 years overall survival rate and expression of EGFR
all patients must have sufficient pretreatment tumor biopsy specimens.
Time frame: 3 years
Use EORTC QLQ-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life
collect date before treatment, the week using neoadjuvant chemotherapy, every week during radiotherapy, 6 months and every year after all treatment finished.
Time frame: 3 years
The relationship between 3 years overall survival rate and amplification of EGFR
all patients must have sufficient pretreatment tumor biopsy specimens.
Time frame: 3 years
The relationship between 3 years overall survival rate and mutation of EGFR
all patients must have sufficient pretreatment tumor biopsy specimens.
Time frame: 3 years