Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer

NCT ID: NCT01074021

Last Updated: 2015-10-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2016-08-31

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.

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.

Conditions

Nasopharyngeal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Nimotuzumab plus chemoradiotherapy

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: 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)

placebo plus chemoradiotherapy

Group Type: PLACEBO_COMPARATOR

placebo plus chemoradiotherapy

Intervention Type: 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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotech Pharmaceutical Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

Xiamen First Hospital

Xiamen, Fujian, China

The Affiliated Cancer Hospital of Guangzhou Medical Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Affiliated Tumor Hospital of Guangxi Medical University

Xining Shequ, Guangxi, China

The Fourth Hebei Province Hospital

Shijiazhuang, Hebei, China

The Affiliated Cancer Hospital of Haerbin Medical University

Haerbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Hubei Province Caner Hospital

Wuhan, Hubei, China

Wuhan Union Hospital

Wuhan, Hubei, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Liaoning Province Cancer Hospital

Shenyang, Liaoning, China

Shandong Caner Hospital

Jinan, Shandong, 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, China

Cancer Institute & Hospital.Chinese Academy of Medical Sciences

Beijing, , China

Peking Union Medical College Hospital

Beijing, , China

Beijing Cancer Hospital

Beijing, , China

The General Hospital of the People's Liberation Army

Beijing, , China

The Affiliated Renji Hosptial of ShanghaiJiao Tong University

Shanghai, , China

Fudan University Shanghai Cancer Center

Shanghai, , China

Tianjin Cancer Hospital

Tianjin, , China

Countries

China

Other Identifiers

BT-CT-001

Identifier Type: -

Identifier Source: org_study_id