Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer

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

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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

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

Condition

Nasopharyngeal Cancer

Intervention

Nimotuzumab

Study Arms / Comparison Groups

 Nimotuzumab plus chemoradiotherapy

Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

October 2009

Completion Date

August 2016

Primary Completion Date

May 2016

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

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT01074021

Organization ID

BT-CT-001

Responsible Party

Sponsor

Study Sponsor

Biotech Pharmaceutical Co., Ltd.

Study Sponsor

, ,

Verification Date

August 2015