Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Nasopharyngeal Cancer |
Drug: Nimotuzumab Drug: placebo plus chemoradiotherapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- 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 ] [ Designated as safety issue: No ]
- To determine the safety of the treatment with Nimotuzumab in combination with chemoradiation [ Time Frame: within study period ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- To determine the Progression free suivival、Diease free survival、Overall survival in the patients subject to the treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 480 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Nimotuzumab plus chemoradiotherapy |
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 Comparator: placebo plus chemoradiotherapy |
Drug: 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) |
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Hide Study Locations| China, Fujan | |
| Fujian Provincial Cancer Hospital | Recruiting |
| Fuzhou, Fujan, China | |
| Contact: Jianji Pan panjianji@126.com | |
| Principal Investigator: Jianji Pan | |
| China, Fujian | |
| Fujian Medical University Union Hospital | Recruiting |
| Fuzhou, Fujian, China, 350001 | |
| Contact: Benhua Xu 86-13696884375 benhuax@hotmail.com | |
| Principal Investigator: Benhua Xu | |
| Fuzhou General Hospital | Not yet recruiting |
| Fuzhou, Fujian, China | |
| Contact: Huihua Chen chenghuihua@hotmail.com | |
| Principal Investigator: Huihua Chen | |
| Xiamen First Hospital | Recruiting |
| Xiamen, Fujian, China, 361003 | |
| Contact: Qin Lin 86-13806000926 linqin05@yahoo.com.cn | |
| Principal Investigator: Qin Lin | |
| China, Guan Dong | |
| Sun Yat-Sen University Cancer Center | Not yet recruiting |
| GuangZhou, Guan Dong, China, 510060 | |
| Contact: Taixiang Lu lutx@mail.sysu.edu.cn | |
| Principal Investigator: Taixiang Lu | |
| China, Guangdong | |
| The Affiliated Cancer Hospital of Guangzhou Medical Hospital | Recruiting |
| Guangzhou, Guangdong, China, 510095 | |
| Contact: Xiuping Zhang 86-13560162815 Zhangxp05@yahoo.com.cn | |
| Principal Investigator: Xiuping Zhang | |
| China, Guangxi | |
| The First Affiliated Hospital of Guangxi Medical University | Recruiting |
| Nanning, Guangxi, China | |
| Contact: Rensheng Wang 86-13807806008 wrsgx@yahoo.com.cn | |
| Principal Investigator: Rensheng Wang | |
| China, Hebei | |
| The Fourth Hebei Province Hospital | Recruiting |
| Shijiazhuang, Hebei, China, 050011 | |
| Contact: Yadi Wang 86-13643216655 wangyadi@hotmail.com | |
| Principal Investigator: Yadi Wang | |
| China, Heilongjiang | |
| The Affiliated Cancer Hospital of Haerbin Medical University | Recruiting |
| Haerbin, Heilongjiang, China, 150081 | |
| Contact: Qingshan You 86-13654613051 youqs@sina.com | |
| Principal Investigator: Qingshan You | |
| China, Henan | |
| Henan Cancer Hospital | Recruiting |
| Zhengzhou, Henan, China, 450008 | |
| Contact: Jianhua Wang 86-13938278827 huajian@371.net | |
| Principal Investigator: Jianhua Wang | |
| China, Hubei | |
| Tongji Medical College of Huazhong University of Sicence & Technology | Not yet recruiting |
| Wuhan, Hubei, China | |
| Contact: Guoqing Hu | |
| Principal Investigator: Guoqing Hu | |
| Wuhan Union Hospital | Recruiting |
| Wuhan, Hubei, China | |
| Contact: Gang Wu wugangzr@yahoo.com.cn | |
| Principal Investigator: Gang Wu | |
| Hubei Province Caner Hospital | Recruiting |
| Wuhan, Hubei, China, 430079 | |
| Contact: Desheng Hu hds_005@163.com | |
| Principal Investigator: Desheng Hu | |
| China, Jiangsu | |
| Jiangsu Cancer Hospital | Not yet recruiting |
| Nanjing, Jiangsu, China, 210009 | |
| Contact: Jifeng Feng 86-025-83283303 fjif@vip.sina.com | |
| Principal Investigator: Jifeng Feng | |
| China, Jiangxi | |
| Jiangxi Province Cancer Hospital | Not yet recruiting |
| Nanchang, Jiangxi, China, 330029 | |
| Contact: Jingao Li 86-13970866296 lijingao@hotmail.com | |
| Principal Investigator: Jingao Li | |
| China, Liaoning | |
| Liaoning Province Cancer Hospital | Not yet recruiting |
| Shenyang, Liaoning, China, 110042 | |
| Contact: Shenyu Li 86-13998840275 shenyu_li@163.com | |
| Principal Investigator: Shenyu Li | |
| Shengjing Hospital of China Medical University | Recruiting |
| Shenyang, Liaoning, China, 110003 | |
| Contact: Rong Wu 86-13840355200 wur@sj-hospital.org | |
| Principal Investigator: Rong Wu | |
| China, Shandong | |
| Shandong University Qilu Hospital | Not yet recruiting |
| Jinan, Shandong, China, 250012 | |
| Contact: Yufeng Cheng 86-138-6919-9969 qlcyf@163.com | |
| Principal Investigator: Yufeng Cheng | |
| Shandong Caner Hospital | Recruiting |
| Jinan, Shandong, China, 250117 | |
| Contact: Junfang Hao 86-13806406293 jn7984729@public.jn.sd.cn | |
| Principal Investigator: Junfang Hao | |
| China, Shanghai | |
| The Affiliated Five Sense Organs Hospitals of Fudan University | Not yet recruiting |
| Shanghai, Shanghai, China | |
| Contact: Shengzi Wang | |
| Principal Investigator: Shengzi Wang | |
| China, Shanxi | |
| The First Affiliated Hospital of the Medical College of Xian Jiaotong University | Not yet recruiting |
| Xian, Shanxi, China, 710061 | |
| Contact: Xiaozhi Zhang 86-13992830930 zhang9149@sina.com.cn | |
| Principal Investigator: Xiaozhi Zhang | |
| Xijing Hospital of the Fourth Military Medical University | Not yet recruiting |
| Xian, Shanxi, China, 710032 | |
| Contact: Mei Shi 86-13609249669 Rtdxjh@fmmu.edu.cn | |
| Principal Investigator: Mei Shi | |
| China, Si Chuan | |
| Sichuan Province Cancer Hospital | Recruiting |
| Chengdu, Si Chuan, China | |
| Contact: Jinyi Lang langjy@tfol.com | |
| Principal Investigator: Jinyi Lang | |
| China, Sichuan | |
| West China Medical School, West China Hospital, Sichuan University | Not yet recruiting |
| Chengdu, Sichuan, China | |
| Contact: Ping Li leepingmd68@163.com | |
| Principal Investigator: Ping Li | |
| China, Zhejiang | |
| Zhejiang Cancer Hospital | Recruiting |
| Hangzhou, Zhejiang, China, 310022 | |
| Contact: Xiaozhong Chen 86-135-0571-7886 cxzfyun@sina.com | |
| Principal Investigator: Xiaozhong Chen | |
| China | |
| Beijing Cancer Hospital | Recruiting |
| Beijing, China, 100142 | |
| Contact: Yan Sun 86-13671370026 ysunemail@yahoo.com | |
| Principal Investigator: Yan Sun | |
| The General Hospital of the People's Liberation Army | Recruiting |
| Beijing, China, 100853 | |
| Contact: Lin Ma 86-13911197589 malinpharm@sohu.com | |
| Principal Investigator: Lin Ma | |
| Cancer Institute & Hospital.Chinese Academy of Medical Sciences | Recruiting |
| Beijing, China, 100021 | |
| Contact: Li Gao li_gao2008@yahoo.com.cn | |
| Principal Investigator: Li Gao | |
| Peking Union Medical College Hospital | Recruiting |
| Beijing, China, 100032 | |
| Contact: Chunmei Bai 86-13511071908 baichunmei1964@yahoo.com.cn | |
| Principal Investigator: Chunmei Bai | |
| The Affiliated Renji Hosptial of ShanghaiJiao Tong University | Recruiting |
| Shanghai, China, 200001 | |
| Contact: Ming Ye 86-13901814744 renjiyeming@gmail.com | |
| Principal Investigator: Ming Ye | |
| Fudan University Shanghai Cancer Center | Recruiting |
| ShangHai, China | |
| Contact: Chaosu Hu hucsu62@yahoo.com | |
| Principal Investigator: Chaosu Hu | |
| Tianjin Cancer Hospital | Not yet recruiting |
| Tianjin, China, 300060 | |
| Contact: Peiguo Wang 86-13002273597 wangpeiguo@yahoo.com.cn | |
| Principal Investigator: Peiguo Wang | |
| Principal Investigator: | Jianji Pan | Fujian Provincial Cancer Hospital |
More Information
No publications provided
| Responsible Party: | Jianji-Pan, Fujian Provincial Cancer Hospital |
| ClinicalTrials.gov Identifier: | NCT01074021 History of Changes |
| Other Study ID Numbers: | BT-CT-001 |
| Study First Received: | February 21, 2010 |
| Last Updated: | August 26, 2010 |
| Health Authority: | China: Food and Drug Administration China: Ethics Committee |
Keywords provided by Biotech Pharmaceutical Co., Ltd.:
|
Nimotuzumab Nasopharyngeal cancer chemoradiation |
Additional relevant MeSH terms:
|
Nasopharyngeal Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site |
Neoplasms Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013