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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


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Advanced Nasopharyngeal Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3 months after the Nimotuzumab treatment finished

Safety Issue:

No

Principal Investigator

Jianji Pan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fujian Provincial Cancer Hospital

Authority:

China: Food and Drug Administration

Study ID:

BT-CT-001

NCT ID:

NCT01074021

Start Date:

October 2009

Completion Date:

June 2013

Related Keywords:

  • Advanced Nasopharyngeal Cancer
  • Nimotuzumab
  • Nasopharyngeal cancer
  • chemoradiation
  • Nasopharyngeal Neoplasms

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