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Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer

Primary Purpose

Nasopharyngeal Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
placebo plus chemoradiotherapy
Sponsored by
Biotech Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Cancer focused on measuring Nimotuzumab, Nasopharyngeal cancer, chemoradiation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fujian Medical University Union Hospital
  • Fujian Provincial Cancer Hospital
  • Xiamen First Hospital
  • The Affiliated Cancer Hospital of Guangzhou Medical Hospital
  • The First Affiliated Hospital of Guangxi Medical University
  • Affiliated Tumor Hospital of Guangxi Medical University
  • The Fourth Hebei Province Hospital
  • The Affiliated Cancer Hospital of Haerbin Medical University
  • Henan Cancer Hospital
  • Hubei Province Caner Hospital
  • Wuhan Union Hospital
  • Shengjing Hospital of China Medical University
  • Liaoning Province Cancer Hospital
  • Shandong Caner Hospital
  • Sichuan Province Cancer Hospital
  • West China School of Medicine/West China Hospital of Sichuan University (WCSM/WCH)
  • Zhejiang Cancer Hospital
  • Cancer Institute & Hospital.Chinese Academy of Medical Sciences
  • Peking Union Medical College Hospital
  • Beijing Cancer Hospital
  • The General Hospital of the People's Liberation Army
  • The Affiliated Renji Hosptial of ShanghaiJiao Tong University
  • Fudan University Shanghai Cancer Center
  • Tianjin Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nimotuzumab plus chemoradiotherapy

placebo plus chemoradiotherapy

Arm Description

Outcomes

Primary Outcome Measures

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
To determine the safety of the treatment with Nimotuzumab in combination with chemoradiation

Secondary Outcome Measures

To determine the Disease-free survival、Tumor control probability、Distant recurrence rate in the patients subject to the treatment at years 1,2,3
To determine the Progression free suivival、Diease free survival、Overall survival in the patients subject to the treatment

Full Information

First Posted
February 21, 2010
Last Updated
October 28, 2015
Sponsor
Biotech Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01074021
Brief Title
Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotech Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Cancer
Keywords
Nimotuzumab, Nasopharyngeal cancer, chemoradiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nimotuzumab plus chemoradiotherapy
Arm Type
Experimental
Arm Title
placebo plus chemoradiotherapy
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Intervention Description
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
Intervention Name(s)
placebo plus chemoradiotherapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
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
Title
To determine the safety of the treatment with Nimotuzumab in combination with chemoradiation
Time Frame
within study period
Secondary Outcome Measure Information:
Title
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
Title
To determine the Progression free suivival、Diease free survival、Overall survival in the patients subject to the treatment
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Fujian Provincial Cancer Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Xiamen First Hospital
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
The Affiliated Cancer Hospital of Guangzhou Medical Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510095
Country
China
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Facility Name
Affiliated Tumor Hospital of Guangxi Medical University
City
Xining
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
The Fourth Hebei Province Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
Facility Name
The Affiliated Cancer Hospital of Haerbin Medical University
City
Haerbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Hubei Province Caner Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110003
Country
China
Facility Name
Liaoning Province Cancer Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
Shandong Caner Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
Sichuan Province Cancer Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
West China School of Medicine/West China Hospital of Sichuan University (WCSM/WCH)
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Cancer Institute & Hospital.Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
The General Hospital of the People's Liberation Army
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
The Affiliated Renji Hosptial of ShanghaiJiao Tong University
City
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
ShangHai
Country
China
Facility Name
Tianjin Cancer Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China

12. IPD Sharing Statement

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Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer

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