Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma
NCT ID: NCT01271439
Last Updated: 2013-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2010-09-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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cetuximab
Cetuximab
400mg/m2 intravenous infusion the week before radiotherapy, 250mg/m2 intravenous infusion weekly for 6 weeks during radiotherapy
Interventions
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Cetuximab
400mg/m2 intravenous infusion the week before radiotherapy, 250mg/m2 intravenous infusion weekly for 6 weeks during radiotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
69 Years
ALL
Yes
Sponsors
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Zhejiang Cancer Hospital
OTHER
Wenzhou Medical University
OTHER
The First Affiliate Hospital of Guangxi Medical College
UNKNOWN
Xijing Hospital
OTHER
Hunan Cancer Hospital
OTHER
Jiangxi Provincial Cancer Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Wuhan University
OTHER
Hubei Cancer Hospital
OTHER
Tongji University
OTHER
Affiliated Cancer Hospital of Shantou University Medical College
OTHER
Shenzhen People's Hospital
OTHER
First People's Hospital of Foshan
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Zhao Chong
MD
Principal Investigators
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Chong Zhao
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Yunfeng Zhou
Role: PRINCIPAL_INVESTIGATOR
Zhongnan Hospital
Locations
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Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Related Links
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Home Page of Cancer Center, Sun Yat-sen University
Other Identifiers
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REPLACE
Identifier Type: -
Identifier Source: org_study_id