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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimotuzumab plus chemoradiotherapy | Experimental |
| |
| placebo plus chemoradiotherapy | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| To determine the safety of the treatment with Nimotuzumab in combination with chemoradiation | within study period |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| To determine the Progression free suivival、Diease free survival、Overall survival in the patients subject to the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China | ||
| Fujian Provincial Cancer Hospital |
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|
| placebo plus chemoradiotherapy | Drug | 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) |
|
| 3 years |
| Fuzhou |
| Fujian |
| China |
| Xiamen First Hospital | Xiamen | Fujian | 361003 | China |
| The Affiliated Cancer Hospital of Guangzhou Medical Hospital | Guangzhou | Guangdong | 510095 | China |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | China |
| Affiliated Tumor Hospital of Guangxi Medical University | Xining Shequ | Guangxi | 530021 | China |
| The Fourth Hebei Province Hospital | Shijiazhuang | Hebei | 050011 | China |
| The Affiliated Cancer Hospital of Haerbin Medical University | Haerbin | Heilongjiang | 150081 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
| Hubei Province Caner Hospital | Wuhan | Hubei | 430079 | China |
| Wuhan Union Hospital | Wuhan | Hubei | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110003 | China |
| Liaoning Province Cancer Hospital | Shenyang | Liaoning | 110042 | China |
| Shandong Caner Hospital | Jinan | Shandong | 250117 | China |
| Sichuan Province Cancer Hospital | Chengdu | Sichuan | China |
| West China School of Medicine/West China Hospital of Sichuan University (WCSM/WCH) | Chengdu | Sichuan | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Cancer Institute & Hospital.Chinese Academy of Medical Sciences | Beijing | 100021 | China |
| Peking Union Medical College Hospital | Beijing | 100032 | China |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| The General Hospital of the People's Liberation Army | Beijing | 100853 | China |
| The Affiliated Renji Hosptial of ShanghaiJiao Tong University | Shanghai | 200001 | China |
| Fudan University Shanghai Cancer Center | Shanghai | China |
| Tianjin Cancer Hospital | Tianjin | 300060 | China |
| ID | Term |
|---|---|
| D009303 | Nasopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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