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

Sun Yat-sen University1 site in 1 country60 target enrollmentSeptember 2010

ConditionsNasopharyngeal Carcinoma

InterventionsCetuximab

DrugsCetuximab

Overview

Phase: Phase 2
Intervention: Cetuximab
Conditions: Nasopharyngeal Carcinoma
Sponsor: Sun Yat-sen University
Enrollment: 60
Locations: 1
Primary Endpoint: 3 Month Complete Response Rate + Partial Response Rate
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

December 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Zhao Chong

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Histologic diagnosis of nasopharyngeal carcinoma
•Range from 18～69 years old
•T3-4，N0-2，M0 (AJCC 2009)
•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

Arms & Interventions

cetuximab

Intervention: Cetuximab

Outcomes

Primary Outcomes

3 Month Complete Response Rate + Partial Response Rate

Time Frame: 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 Outcomes

One-year locoregional control rate(1 year)
Three-year locoregional control rate(3 years)
One-year disease free survival rate(1 year)
Three-year disease free survival rate(3 years)
One-year overall survival rate(1 year)
Three-year overall survival rate(3 years)
The relationship between 3 years overall survival rate and expression of EGFR(3 years)
Use EORTC QLQ-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life(3 years)
The relationship between 3 years overall survival rate and amplification of EGFR(3 years)
The relationship between 3 years overall survival rate and mutation of EGFR(3 years)