Nasopharyngeal Carcinoma
Conditions
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.
Interventions
DRUGCetuximab
400mg/m2 intravenous infusion the week before radiotherapy, 250mg/m2 intravenous infusion weekly for 6 weeks during radiotherapy
Sponsors
Zhejiang Cancer Hospital
Wenzhou Medical University
The First Affiliate Hospital of Guangxi Medical College
Xijing Hospital
Hunan Cancer Hospital
Jiangxi Provincial Cancer Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan University
Hubei Cancer Hospital
Tongji University
Affiliated Cancer Hospital of Shantou University Medical College
Shenzhen People's Hospital
First People's Hospital of Foshan
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Three-year overall survival rate | 3 years | overall survival rate: from the time when finish treatment to death of any cause. |
Countries
China
Outcome results
None listed