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

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

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 Overview

• Status: Completed
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: Cetuximab

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Cancer Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cetuximab	Drug: Cetuximab; 400mg/m2 intravenous infusion the week before radiotherapy, 250mg/m2 intravenous infusion weekly for 6 weeks during radiotherapy; Other Names: C225

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
One-year disease free survival rate	disease free survival rate: from the time when finish treatment to first failure at any site.	1 year
Three-year disease free survival rate	disease free survival rate: from the time when finish treatment to first failure at any site.	3 years
One-year overall survival rate	overall survival rate: from the time when finish treatment to death of any cause.	1 year
Three-year overall survival rate	overall survival rate: from the time when finish treatment to death of any cause.	3 years
The relationship between 3 years overall survival rate and expression of EGFR	all patients must have sufficient pretreatment tumor biopsy specimens.	3 years
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
The relationship between 3 years overall survival rate and amplification of EGFR	all patients must have sufficient pretreatment tumor biopsy specimens.	3 years
The relationship between 3 years overall survival rate and mutation of EGFR	all patients must have sufficient pretreatment tumor biopsy specimens.	3 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Zhejiang Cancer Hospital; Wenzhou Medical University; Xijing Hospital; Wuhan University; Hubei Cancer Hospital; Hunan Cancer Hospital; Jiangxi Provincial Cancer Hospital; Shenzhen People's Hospital; Wuhan Union Hospital, China; Tongji University; The First Affiliate Hospital of Guangxi Medical College; Affiliated Cancer Hospital of Shantou University Medical College; First People's Hospital of Foshan
• Investigators: Principal Investigator: Chong Zhao, Sun Yat-sen University; Principal Investigator: Yunfeng Zhou, Wuhan University

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: January 5, 2011
• First Submitted That Met QC Criteria: January 5, 2011
• First Posted (Estimate): January 6, 2011

Study Record Updates

• Last Update Posted (Estimate): August 13, 2013
• Last Update Submitted That Met QC Criteria: August 10, 2013
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cetuximab
• Other Study ID Numbers: REPLACE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No