Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma
- Registration Number
- NCT01271439
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Histologic diagnosis of nasopharyngeal carcinoma
- Range from 18～69 years old
- T3-4，N0-2，M0 (AJCC 2009)
- KPS ≥ 80
- Nonmetastatic diseases
- WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
- ALT or AST < 1.5×ULN、bilirubin < 1.5×ULN
- 0Serum creatinine < 1.5×ULN
- Distance metastases
- Previously treated (surgery，chemotherapy, radiation therapy，EGFR targeted therapy or immunotherapy)
- Second malignancy within 5 years
- Precious therapy with an investigational agent
- Uncontrolled seizure disorder or other serious neurologic disease
- ≥ Grade Ш allergic reaction to any drug including in this study
- Clinically significant cardiac or respiratory disease
- Creatinine clearance < 30ml/min
- Drug or alcohol addition
- Do not have full capacity for civil acts
- Severe complication, active infection
- Concurrent immunotherapy or hormone therapy for other diseases
- Pregnancy or lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description cetuximab Cetuximab -
- Primary Outcome Measures
Name Time Method 3 Month Complete Response Rate + Partial Response Rate 3 Months 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.
- Secondary Outcome Measures
Name Time Method One-year locoregional control rate 1 year locoregional control rate: from the time when finish treatment to persistence or recurrence in the nasopharyngeal and/or cervical region.
Three-year locoregional control rate 3 years locoregional control rate: from the time when finish treatment to persistence or recurrence in the nasopharyngeal and/or cervical region.
One-year disease free survival rate 1 year disease free survival rate: from the time when finish treatment to first failure at any site.
Three-year disease free survival rate 3 years disease free survival rate: from the time when finish treatment to first failure at any site.
One-year overall survival rate 1 year overall survival rate: from the time when finish treatment to death of any cause.
Three-year overall survival rate 3 years overall survival rate: from the time when finish treatment to death of any cause.
The relationship between 3 years overall survival rate and expression of EGFR 3 years all patients must have sufficient pretreatment tumor biopsy specimens.
Use EORTC QLQ-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life 3 years collect date before treatment, the week using neoadjuvant chemotherapy, every week during radiotherapy, 6 months and every year after all treatment finished.
The relationship between 3 years overall survival rate and amplification of EGFR 3 years all patients must have sufficient pretreatment tumor biopsy specimens.
The relationship between 3 years overall survival rate and mutation of EGFR 3 years all patients must have sufficient pretreatment tumor biopsy specimens.
Trial Locations
- Locations (1)
Cancer Center, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China