Overview

Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma

Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Sun Yat-sen University
Collaborators:
Affiliated Cancer Hospital of Shantou University Medical College
Cancer Hospital of Shantou University
First People's Hospital of Foshan
Hubei Cancer Hospital
Hunan Cancer Hospital
Jiangxi Provincial Cancer Hospital
Shenzhen People's Hospital
The First Affiliate Hospital of Guangxi Medical College
Tongji University
Wenzhou Medical University
Wuhan Union Hospital, China
Wuhan University
Xijing Hospital
Zhejiang Cancer Hospital
Treatments:
Cetuximab
Criteria
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