Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer
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
1 other identifier
interventional
480
1 country
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2009
Longer than P75 for phase_3
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 21, 2010
CompletedFirst Posted
Study publicly available on registry
February 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedOctober 30, 2015
August 1, 2015
6.6 years
February 21, 2010
October 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (2)
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
3 years
Study Arms (2)
Nimotuzumab plus chemoradiotherapy
EXPERIMENTALplacebo plus chemoradiotherapy
PLACEBO COMPARATORInterventions
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 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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Fujian Provincial Cancer Hospital
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2010
First Posted
February 24, 2010
Study Start
October 1, 2009
Primary Completion
May 1, 2016
Study Completion
August 1, 2016
Last Updated
October 30, 2015
Record last verified: 2015-08