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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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
3 months after the Nimotuzumab treatment finished
No
Jianji Pan
Principal Investigator
Fujian Provincial Cancer Hospital
China: Food and Drug Administration
BT-CT-001
NCT01074021
October 2009
June 2013
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