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

This study is currently recruiting participants.
Verified November 2011 by Sun Yat-sen University
Sponsor:
Collaborators:
Zhejiang Cancer Hospital
Wenzhou Medical College
The First Affiliate Hospital of Guangxi Medical College
Xijing Hospital
Hunan Cancer Hospital
Jiangxi Cancer Hospital
Wuhan Union Hospital, China
Wuhan University
Hubei Cancer Hospital
Tongji University
Cancer Hospital of Shantou University
Shenzhen People's Hospital
First People's Hospital of Foshan
Information provided by (Responsible Party):
Zhao Chong, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01271439
First received: January 5, 2011
Last updated: June 4, 2012
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Nasopharyngeal Carcinoma
 Drug: Cetuximab
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Neoadjuvant Chemotherapy + IMRT Combined With Cetuximab in Advanced T Stage of Nasopharyngeal Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Cetuximab
U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • 3 Month Complete Response Rate + Partial Response Rate [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • One-year locoregional control rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    locoregional control rate: from the time when finish treatment to persistence or recurrence in the nasopharyngeal and/or cervical region.

  • Three-year locoregional control rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    locoregional control rate: from the time when finish treatment to persistence or recurrence in the nasopharyngeal and/or cervical region.

  • One-year disease free survival rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    disease free survival rate: from the time when finish treatment to first failure at any site.

  • Three-year disease free survival rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    disease free survival rate: from the time when finish treatment to first failure at any site.

  • One-year overall survival rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    overall survival rate: from the time when finish treatment to death of any cause.

  • Three-year overall survival rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    overall survival rate: from the time when finish treatment to death of any cause.

  • The relationship between 3 years overall survival rate and expression of EGFR [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    all patients must have sufficient pretreatment tumor biopsy specimens.

  • Use EORTC QLQ-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    collect date before treatment, the week using neoadjuvant chemotherapy, every week during radiotherapy, 6 months and every year after all treatment finished.

  • The relationship between 3 years overall survival rate and amplification of EGFR [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    all patients must have sufficient pretreatment tumor biopsy specimens.

  • The relationship between 3 years overall survival rate and mutation of EGFR [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    all patients must have sufficient pretreatment tumor biopsy specimens.


Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cetuximab
    400mg/m2 intravenous infusion the week before radiotherapy, 250mg/m2 intravenous infusion weekly for 6 weeks during radiotherapy
    Other Name: C225
  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271439

Contacts
Contact: Chong Zhao 86-13902206160 zhaochong@sysucc.org.cn

Locations
China, Guangdong
Cancer Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Chong Zhao     +86-13902206160     zhaochong@sysucc.org.cn    
Contact: Yunfeng Zhou     +86-027-67813096        
Sponsors and Collaborators
Sun Yat-sen University
Zhejiang Cancer Hospital
Wenzhou Medical College
The First Affiliate Hospital of Guangxi Medical College
Xijing Hospital
Hunan Cancer Hospital
Jiangxi Cancer Hospital
Wuhan Union Hospital, China
Wuhan University
Hubei Cancer Hospital
Tongji University
Cancer Hospital of Shantou University
Shenzhen People's Hospital
First People's Hospital of Foshan
Investigators
Principal Investigator: Chong Zhao Sun Yat-sen University
Principal Investigator: Yunfeng Zhou Wuhan University
  More Information

Additional Information:
Home Page of Cancer Center, Sun Yat-sen University  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Zhao Chong, MD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01271439     History of Changes
Other Study ID Numbers: REPLACE
Study First Received: January 5, 2011
Last Updated: June 4, 2012
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
 Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013