Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer
This trial is active, not recruiting.
|Treatments||nimotuzumab, placebo plus chemoradiotherapy|
|Sponsor||Biotech Pharmaceutical Co., Ltd.|
|Start date||October 2009|
|End date||May 2016|
|Trial size||480 participants|
|Trial identifier||NCT01074021, BT-CT-001|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Fuzhou, China||Fujian Medical University Union Hospital||no longer recruiting|
|Fuzhou, China||Fujian Provincial Cancer Hospital||no longer recruiting|
|Xiamen, China||Xiamen First Hospital||no longer recruiting|
|Guangzhou, China||The Affiliated Cancer Hospital of Guangzhou Medical Hospital||no longer recruiting|
|Nanning, China||The First Affiliated Hospital of Guangxi Medical University||no longer recruiting|
|Xining, China||Affiliated Tumor Hospital of Guangxi Medical University||no longer recruiting|
|Shijiazhuang, China||The Fourth Hebei Province Hospital||no longer recruiting|
|Haerbin, China||The Affiliated Cancer Hospital of Haerbin Medical University||no longer recruiting|
|Zhengzhou, China||Henan Cancer Hospital||no longer recruiting|
|Wuhan, China||Hubei Province Caner Hospital||no longer recruiting|
|Wuhan, China||Wuhan Union Hospital||no longer recruiting|
|Shenyang, China||Liaoning Province Cancer Hospital||no longer recruiting|
|Shenyang, China||Shengjing Hospital of China Medical University||no longer recruiting|
|Jinan, China||Shandong Caner Hospital||no longer recruiting|
|Chengdu, China||Sichuan Province Cancer Hospital||no longer recruiting|
|Chengdu, China||West China School of Medicine/West China Hospital of Sichuan University (WCSM/WCH)||no longer recruiting|
|Hangzhou, China||Zhejiang Cancer Hospital||no longer recruiting|
|Beijing, China||Beijing Cancer Hospital||no longer recruiting|
|Beijing, China||Cancer Institute & Hospital.Chinese Academy of Medical Sciences||no longer recruiting|
|Beijing, China||Peking Union Medical College Hospital||no longer recruiting|
|Beijing, China||The General Hospital of the People's Liberation Army||no longer recruiting|
|ShangHai, China||Fudan University Shanghai Cancer Center||no longer recruiting|
|Shanghai, China||The Affiliated Renji Hosptial of ShanghaiJiao Tong University||no longer recruiting|
|Tianjin, China||Tianjin Cancer Hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
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
time frame: 3 months after the Nimotuzumab treatment finished
To determine the safety of the treatment with Nimotuzumab in combination with chemoradiation
time frame: within study period
To determine the Disease-free survival、Tumor control probability、Distant recurrence rate in the patients subject to the treatment at years 1,2,3
time frame: 3 year
To determine the Progression free suivival、Diease free survival、Overall survival in the patients subject to the treatment
time frame: 3 years
Male or female participants from 18 years up to 70 years old.
- 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
- 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
|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|
|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.|
Call for more information