Back to resultsStudy of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma (REPLACE)
Primary Purpose
Nasopharyngeal Carcinoma
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma
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
Sites / Locations
- Cancer Center, Sun Yat-sen University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cetuximab
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
One-year disease free survival rate
disease free survival rate: from the time when finish treatment to first failure at any site.
Three-year disease free survival rate
disease free survival rate: from the time when finish treatment to first failure at any site.
One-year overall survival rate
overall survival rate: from the time when finish treatment to death of any cause.
Three-year overall survival rate
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
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
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
all patients must have sufficient pretreatment tumor biopsy specimens.
The relationship between 3 years overall survival rate and mutation of EGFR
all patients must have sufficient pretreatment tumor biopsy specimens.
Full Information
NCT ID
NCT01271439
First Posted
January 5, 2011
Last Updated
August 10, 2013
Sponsor
Sun Yat-sen University
Collaborators
Zhejiang Cancer Hospital, Wenzhou Medical University, The First Affiliate Hospital of Guangxi Medical College, Xijing Hospital, Hunan Cancer Hospital, Jiangxi Provincial Cancer Hospital, Wuhan Union Hospital, China, Wuhan University, Hubei Cancer Hospital, Tongji University, Affiliated Cancer Hospital of Shantou University Medical College, Shenzhen People's Hospital, First People's Hospital of Foshan
1. Study Identification
Unique Protocol Identification Number
NCT01271439
Brief Title
Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma
Acronym
REPLACE
Official Title
A Phase II Study of Neoadjuvant Chemotherapy + IMRT Combined With Cetuximab in Advanced T Stage of Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Zhejiang Cancer Hospital, Wenzhou Medical University, The First Affiliate Hospital of Guangxi Medical College, Xijing Hospital, Hunan Cancer Hospital, Jiangxi Provincial Cancer Hospital, Wuhan Union Hospital, China, Wuhan University, Hubei Cancer Hospital, Tongji University, Affiliated Cancer Hospital of Shantou University Medical College, Shenzhen People's Hospital, First People's Hospital of Foshan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cetuximab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
C225
Intervention Description
400mg/m2 intravenous infusion the week before radiotherapy, 250mg/m2 intravenous infusion weekly for 6 weeks during radiotherapy
Primary Outcome Measure Information:
Title
3 Month Complete Response Rate + Partial Response Rate
Description
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.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
One-year locoregional control rate
Description
locoregional control rate: from the time when finish treatment to persistence or recurrence in the nasopharyngeal and/or cervical region.
Time Frame
1 year
Title
Three-year locoregional control rate
Description
locoregional control rate: from the time when finish treatment to persistence or recurrence in the nasopharyngeal and/or cervical region.
Time Frame
3 years
Title
One-year disease free survival rate
Description
disease free survival rate: from the time when finish treatment to first failure at any site.
Time Frame
1 year
Title
Three-year disease free survival rate
Description
disease free survival rate: from the time when finish treatment to first failure at any site.
Time Frame
3 years
Title
One-year overall survival rate
Description
overall survival rate: from the time when finish treatment to death of any cause.
Time Frame
1 year
Title
Three-year overall survival rate
Description
overall survival rate: from the time when finish treatment to death of any cause.
Time Frame
3 years
Title
The relationship between 3 years overall survival rate and expression of EGFR
Description
all patients must have sufficient pretreatment tumor biopsy specimens.
Time Frame
3 years
Title
Use EORTC QLQ-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life
Description
collect date before treatment, the week using neoadjuvant chemotherapy, every week during radiotherapy, 6 months and every year after all treatment finished.
Time Frame
3 years
Title
The relationship between 3 years overall survival rate and amplification of EGFR
Description
all patients must have sufficient pretreatment tumor biopsy specimens.
Time Frame
3 years
Title
The relationship between 3 years overall survival rate and mutation of EGFR
Description
all patients must have sufficient pretreatment tumor biopsy specimens.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chong Zhao
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yunfeng Zhou
Organizational Affiliation
Wuhan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Links:
URL
http://www.sysucc.org.cn
Description
Home Page of Cancer Center, Sun Yat-sen University
Learn more about this trial
Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma
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