Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma

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.

Conditions

• Nasopharyngeal Carcinoma

Interventions

DRUG

Cetuximab

400mg/m2 intravenous infusion the week before radiotherapy, 250mg/m2 intravenous infusion weekly for 6 weeks during radiotherapy

Sponsors & Collaborators

• Zhejiang Cancer Hospital

  collaborator OTHER

• Wenzhou Medical University

  collaborator OTHER

• The First Affiliate Hospital of Guangxi Medical College

  collaborator UNKNOWN

• Xijing Hospital

  collaborator OTHER

• Hunan Cancer Hospital

  collaborator OTHER

• Jiangxi Provincial Cancer Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Wuhan University

  collaborator OTHER

• Hubei Cancer Hospital

  collaborator OTHER

• Tongji University

  collaborator OTHER

• Affiliated Cancer Hospital of Shantou University Medical College

  collaborator OTHER

• Shenzhen People's Hospital

  collaborator OTHER

• First People's Hospital of Foshan

  collaborator OTHER

• Sun Yat-sen University

  lead OTHER

Principal Investigators

• Chong Zhao · Sun Yat-sen University

• Yunfeng Zhou · Zhongnan Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-09-30

Primary Completion

2012-06-30

Completion

2012-12-31

Countries

• China

Study Locations