Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Study of Neoadjuvant Chemotherapy + IMRT Combined With Cetuximab in Advanced T Stage of Nasopharyngeal Carcinoma

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: Cetuximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cetuximab<br> | Drug: Cetuximab<br>* 400mg/m2 intravenous infusion the week before radiotherapy, 250mg/m2 intravenous infusion weekly for 6 weeks during radiotherapy<br>* Other names: C225;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3 years | 
| One-year disease free survival rate | disease free survival rate: from the time when finish treatment to first failure at any site. | 1 year | 
| Three-year disease free survival rate | disease free survival rate: from the time when finish treatment to first failure at any site. | 3 years | 
| One-year overall survival rate | overall survival rate: from the time when finish treatment to death of any cause. | 1 year | 
| Three-year overall survival rate | overall survival rate: from the time when finish treatment to death of any cause. | 3 years | 
| The relationship between 3 years overall survival rate and expression of EGFR | all patients must have sufficient pretreatment tumor biopsy specimens. | 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. | 3 years | 
| The relationship between 3 years overall survival rate and amplification of EGFR | all patients must have sufficient pretreatment tumor biopsy specimens. | 3 years | 
| The relationship between 3 years overall survival rate and mutation of EGFR | all patients must have sufficient pretreatment tumor biopsy specimens. | 3 years |