Clinical trial NCT01074021: Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer
Official title: A Prospective,Randomized,Double-Blind,Controlled,Multicenter,Phase III Study of Nimotuzumab in Combination With Chemotherapy and Radiotherapy for Patients With Local Advanced Nasopharyngeal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nasopharyngeal Cancer
Keywords: Nimotuzumab
Nasopharyngeal cancer
chemoradiation
Lead sponsor: Biotech Pharmaceutical Co., Ltd.
Sponsor class: OTHER
First posted: 2010-02-24
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate nimotuzumab in different indications. Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. The Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with chemotherapy and radiotherapy in patients with advanced nasopharyngeal cancer.

Detailed description: Patients with advanced nasopharyngeal cancer will be randomized to 2 arms. The patients in experimental arm will be treated with Nimotuzumab which will be used concurrently with radiotherapy and chemotherapy. The chemotherapy regimen were Cisplatin monotherapy. The active comparator arm will be administered chemotherapy and radiotherapy only. The dose and regimen were the same with experiment arm. The patients'hematopoietic , hepatic and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed at the first and the fourth month, and followup every six months to evaluate the survival index in three years after the study.

Eligibility criteria: Inclusion Criteria:

* Joined the study voluntary and signed informed consent form
* Age 18-70，both genders.
* Nasopharyngeal cancer was confirmed by pathology.
* Nasopharyngeal cancer 2008 Stages: Ⅲ/Ⅳa.
* Primary lesions can measurable.
* Karnofsky Performance Scale \>70.
* Life expectancy of more than 6 months.
* Use of an effective contraceptive method for women when there is a risk of pregnancy during the study.
* Haemoglobin≥100g/L ,WBC ≥4×109/L, platelet count≥100×109/L
* Hepatic function:ALAT、ASAT\< 1.5 x ULN, TBIL\< 1.5 x ULN
* Renal function: Creatinine \< 1.5 x ULN

Exclusion Criteria:

* Evidence of distant metastasis
* Primary lesions or lymph node have been operated (except of operation for biopsy)
* Previous radiotherapy
* Received other anti EGFR monoclonal antibody treatment
* Previous chemotherapy or immunization therapy
* Other malignant tumor (except of Non-melanoma Skin Cancer or carcinoma in situ of cervix)
* Participation in other interventional clinical trials within 1 month
* Peripheral neuropathy is more than I stage
* Pregnant or breast-feeding women and women who refused to take contraceptive method
* History of serious allergic or allergy
* History of Serious lung or heart disease
* Refused or can't signed informed consent form
* Drug abuse or alcohol addiction
* Personality or psychiatric disease, and persons without capacity for civil conduct or persons with limited capacity for civil conduct

Primary outcomes:
measure: To determine the local-regional control rates of the disease in the advanced nasopharyngeal cancer patients subject to the treatment with Nimotuzumab in combination with chemoradiation
timeFrame: 3 months after the Nimotuzumab treatment finished
measure: To determine the safety of the treatment with Nimotuzumab in combination with chemoradiation
timeFrame: within study period
Secondary outcomes:
measure: To determine the Disease-free survival、Tumor control probability、Distant recurrence rate in the patients subject to the treatment at years 1,2,3
timeFrame: 3 year
measure: To determine the Progression free suivival、Diease free survival、Overall survival in the patients subject to the treatment
timeFrame: 3 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital
state: Fujian
city: Xiamen
country: China
facility: Xiamen First Hospital
state: Fujian
city: Guangzhou
country: China
facility: The Affiliated Cancer Hospital of Guangzhou Medical Hospital
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Xining
country: China
facility: Affiliated Tumor Hospital of Guangxi Medical University
state: Guangxi
city: Shijiazhuang
country: China
facility: The Fourth Hebei Province Hospital
state: Hebei
city: Haerbin
country: China
facility: The Affiliated Cancer Hospital of Haerbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Hubei Province Caner Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Province Cancer Hospital
state: Liaoning
city: Jinan
country: China
facility: Shandong Caner Hospital
state: Shandong
city: Chengdu
country: China
facility: Sichuan Province Cancer Hospital
state: Sichuan
city: Chengdu
country: China
facility: West China School of Medicine/West China Hospital of Sichuan University (WCSM/WCH)
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Beijing
country: China
facility: Cancer Institute & Hospital.Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: The General Hospital of the People's Liberation Army
city: Shanghai
country: China
facility: The Affiliated Renji Hosptial of ShanghaiJiao Tong University
city: ShangHai
country: China
facility: Fudan University Shanghai Cancer Center
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
Study officials:
References: