Clinical trial NCT01271439: Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma
Official title: A Phase II Study of Neoadjuvant Chemotherapy + IMRT Combined With Cetuximab in Advanced T Stage of Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Zhejiang Cancer Hospital
name: Wenzhou Medical University
name: The First Affiliate Hospital of Guangxi Medical College
name: Xijing Hospital
name: Hunan Cancer Hospital
name: Jiangxi Provincial Cancer Hospital
name: Wuhan Union Hospital, China
name: Wuhan University
name: Hubei Cancer Hospital
name: Tongji University
name: Affiliated Cancer Hospital of Shantou University Medical College
name: Shenzhen People's Hospital
name: First People's Hospital of Foshan
First posted: 2011-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 3 Month Complete Response Rate + Partial Response Rate
timeFrame: 3 Months
Secondary outcomes:
measure: One-year locoregional control rate
timeFrame: 1 year
measure: Three-year locoregional control rate
timeFrame: 3 years
measure: One-year disease free survival rate
timeFrame: 1 year
measure: Three-year disease free survival rate
timeFrame: 3 years
measure: One-year overall survival rate
timeFrame: 1 year
measure: Three-year overall survival rate
timeFrame: 3 years
measure: The relationship between 3 years overall survival rate and expression of EGFR
timeFrame: 3 years
measure: Use EORTC QLQ-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life
timeFrame: 3 years
measure: The relationship between 3 years overall survival rate and amplification of EGFR
timeFrame: 3 years
measure: The relationship between 3 years overall survival rate and mutation of EGFR
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Chong Zhao
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongnan Hospital
name: Yunfeng Zhou
role: PRINCIPAL_INVESTIGATOR
References: