Brief Title
Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma
Official Title
A Phase II Study of Neoadjuvant Chemotherapy + IMRT Combined With Cetuximab in Advanced T Stage of Nasopharyngeal Carcinoma
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
3 Month Complete Response Rate + Partial Response Rate
Secondary Outcome
One-year locoregional control rate
Condition
Nasopharyngeal Carcinoma
Intervention
Cetuximab
Study Arms / Comparison Groups
cetuximab
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
60
Start Date
September 2010
Completion Date
December 2012
Primary Completion Date
June 2012
Eligibility 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
Gender
All
Ages
18 Years - 69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Chong Zhao, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01271439
Organization ID
REPLACE
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Collaborators
Zhejiang Cancer Hospital
Study Sponsor
Chong Zhao, Principal Investigator, Sun Yat-sen University
Verification Date
November 2011