Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer

October 28, 2015 updated by: Biotech Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, China, 100032
        • Peking Union Medical College Hospital
      • Beijing, China, 100021
        • Cancer Institute & Hospital.Chinese Academy of Medical Sciences
      • Beijing, China, 100853
        • The General Hospital of the People's Liberation Army
      • ShangHai, China
        • Fudan University Shanghai Cancer Center
      • Shanghai, China, 200001
        • The Affiliated Renji Hosptial of ShanghaiJiao Tong University
      • Tianjin, China, 300060
        • Tianjin Cancer Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
      • Fuzhou, Fujian, China
        • Fujian Provincial Cancer Hospital
      • Xiamen, Fujian, China, 361003
        • Xiamen First Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510095
        • The Affiliated Cancer Hospital of Guangzhou Medical Hospital
    • Guangxi
      • Nanning, Guangxi, China
        • The First Affiliated Hospital of Guangxi Medical University
      • Xining, Guangxi, China, 530021
        • Affiliated Tumor Hospital of Guangxi Medical University
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • The Fourth Hebei Province Hospital
    • Heilongjiang
      • Haerbin, Heilongjiang, China, 150081
        • The Affiliated Cancer Hospital of Haerbin Medical University
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Wuhan Union Hospital
      • Wuhan, Hubei, China, 430079
        • Hubei Province Caner Hospital
    • Liaoning
      • Shenyang, Liaoning, China, 110003
        • Shengjing Hospital of China Medical University
      • Shenyang, Liaoning, China, 110042
        • Liaoning Province Cancer Hospital
    • Shandong
      • Jinan, Shandong, China, 250117
        • Shandong Caner Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • Sichuan Province Cancer Hospital
      • Chengdu, Sichuan, China
        • West China School of Medicine/West China Hospital of Sichuan University (WCSM/WCH)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 3 months after the Nimotuzumab treatment finished
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
within study period

Secondary Outcome Measures

Outcome Measure
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
Time Frame: 3 year
3 year
To determine the Progression free suivival、Diease free survival、Overall survival in the patients subject to the treatment
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotech Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

February 21, 2010

First Submitted That Met QC Criteria

February 22, 2010

First Posted (Estimate)

February 24, 2010

Study Record Updates

Last Update Posted (Estimate)

October 30, 2015

Last Update Submitted That Met QC Criteria

October 28, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BT-CT-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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