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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01074021
Other study ID # BT-CT-001
Secondary ID
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


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
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