Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma (REPLACE)

Sun Yat-sen University

Status and phase

Completed

Phase 2

Conditions

Nasopharyngeal Carcinoma

Treatments

Drug: Cetuximab

Study type

Interventional

Funder types

Other

Identifiers

NCT01271439

REPLACE

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 69 years old

Volunteers

Accepts Healthy Volunteers

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