Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

— REPLACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271439
• Other study ID #: REPLACE
• Status: Completed
• Phase: Phase 2
• First received: January 5, 2011
• Last updated: August 10, 2013
• Start date: September 2010
• Est. completion date: December 2012

Study information

• Verified date: November 2011
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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 ? 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Cancer Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (14)

Lead Sponsor	Collaborator
Sun Yat-sen University	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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 Month Complete Response Rate + Partial Response Rate	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.	3 Months	No
Secondary	One-year locoregional control rate	locoregional control rate: from the time when finish treatment to persistence or recurrence in the nasopharyngeal and/or cervical region.	1 year	No
Secondary	Three-year locoregional control rate	locoregional control rate: from the time when finish treatment to persistence or recurrence in the nasopharyngeal and/or cervical region.	3 years	No
Secondary	One-year disease free survival rate	disease free survival rate: from the time when finish treatment to first failure at any site.	1 year	No
Secondary	Three-year disease free survival rate	disease free survival rate: from the time when finish treatment to first failure at any site.	3 years	No
Secondary	One-year overall survival rate	overall survival rate: from the time when finish treatment to death of any cause.	1 year	No
Secondary	Three-year overall survival rate	overall survival rate: from the time when finish treatment to death of any cause.	3 years	No
Secondary	The relationship between 3 years overall survival rate and expression of EGFR	all patients must have sufficient pretreatment tumor biopsy specimens.	3 years	No
Secondary	Use EORTC QLQ-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life	collect date before treatment, the week using neoadjuvant chemotherapy, every week during radiotherapy, 6 months and every year after all treatment finished.	3 years	No
Secondary	The relationship between 3 years overall survival rate and amplification of EGFR	all patients must have sufficient pretreatment tumor biopsy specimens.	3 years	No
Secondary	The relationship between 3 years overall survival rate and mutation of EGFR	all patients must have sufficient pretreatment tumor biopsy specimens.	3 years	No

External Links

•   Home Page of Cancer Center, Sun Yat-sen University