Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer

Nasopharyngeal Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01074021
• Other study ID #: BT-CT-001
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 21, 2010
• Last updated: October 28, 2015
• Start date: October 2009
• Est. completion date: August 2016

Study information

• Verified date: August 2015
• Source: Biotech Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 480
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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: ?/?a.

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasopharyngeal Cancer
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Nimotuzumab
Nimotuzumab:(200mg/w,weekly, 7-8 weeks, one week before radiotherapy) Radiotherapy: IMRT: Nasopharynx: GTV 66-78. 2Gy,CTV1 60-64Gy,CTV2 54-60Gy.30-34 times, 2.20-2.30Gy/time,once a day, 5 days/w, 6-7 weeks. Neck: lymph node positive, GTVn 60-70Gy, once a day, 5 days/w, 6-7weeks; lymph node negative, CTVn50-55Gy, once a day, 5 days/w, 6-7 weeks. CRT: Nasopharynx, 70-(76-80)Gy, 35-(38-40)times, 2Gy/time, once a day, 5 days/w, 6-8weeks. If disease residual when radiotherapy finished could increase the dose appropriate. Neck: lymph node positive, 64-70 Gy, 32-35 times, 2 Gy/time, once a day, 5 days/w, 6-7 weeks; lymph node negative, 50-56 Gy, 25-28 times,2 Gy/time, once a day, 5 days/w, 5-6weeks cisplatin Chemotherapy: Cisplatin (100 mg/m2,1 time/21d, 3 times,on days 2, 23, 44 during the radiotherapy)
• placebo plus chemoradiotherapy
Placebo treatment:4 bottles/w,weekly, 7-8 weeks, one week before radiotherapy Radiotherapy: IMRT: Nasopharynx: GTV 66-78. 2Gy,CTV1 60-64Gy,CTV2 54-60Gy.30-34 times, 2.20-2.30Gy/time,once a day, 5 days/w, 6-7 weeks. Neck: lymph node positive, GTVn 60-70Gy, once a day, 5 days/w, 6-7weeks; lymph node negative, CTVn50-55Gy, once a day, 5 days/w, 6-7 weeks. CRT: Nasopharynx, 70-(76-80)Gy, 35-(38-40)times, 2Gy/time, once a day, 5 days/w, 6-8weeks. If disease residual when radiotherapy finished could increase the dose appropriate. Neck: lymph node positive, 64-70 Gy, 32-35 times, 2 Gy/time, once a day, 5 days/w, 6-7 weeks; lymph node negative, 50-56 Gy, 25-28 times,2 Gy/time, once a day, 5 days/w, 5-6weeks cisplatin Chemotherapy: Cisplatin (100 mg/m2,1 time/21d, 3 times,on days 2, 23, 44 during the radiotherapy)

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	Cancer Institute & Hospital.Chinese Academy of Medical Sciences	Beijing
China	Peking Union Medical College Hospital	Beijing
China	The General Hospital of the People's Liberation Army	Beijing
China	Sichuan Province Cancer Hospital	Chengdu	Sichuan
China	West China School of Medicine/West China Hospital of Sichuan University (WCSM/WCH)	Chengdu	Sichuan
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Fujian Provincial Cancer Hospital	Fuzhou	Fujian
China	The Affiliated Cancer Hospital of Guangzhou Medical Hospital	Guangzhou	Guangdong
China	The Affiliated Cancer Hospital of Haerbin Medical University	Haerbin	Heilongjiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Shandong Caner Hospital	Jinan	Shandong
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Fudan University Shanghai Cancer Center	ShangHai
China	The Affiliated Renji Hosptial of ShanghaiJiao Tong University	Shanghai
China	Liaoning Province Cancer Hospital	Shenyang	Liaoning
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	The Fourth Hebei Province Hospital	Shijiazhuang	Hebei
China	Tianjin Cancer Hospital	Tianjin
China	Hubei Province Caner Hospital	Wuhan	Hubei
China	Wuhan Union Hospital	Wuhan	Hubei
China	Xiamen First Hospital	Xiamen	Fujian
China	Affiliated Tumor Hospital of Guangxi Medical University	Xining	Guangxi
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Biotech Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		3 months after the Nimotuzumab treatment finished	No
Primary	To determine the safety of the treatment with Nimotuzumab in combination with chemoradiation		within study period	Yes
Secondary	To determine the Disease-free survival?Tumor control probability?Distant recurrence rate in the patients subject to the treatment at years 1,2,3		3 year	No
Secondary	To determine the Progression free suivival?Diease free survival?Overall survival in the patients subject to the treatment		3 years	No