Induction Chemotherapy With Nimotuzumab in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
NCT00910117 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2012-02-20
Summary
The aim of the study is to evaluate the role of nimotuzumab in the neo-adjuvant setting in patients with locally advanced HNSCC. The hypothesis is that the response would be increased with the combination of nimotuzumab and cisplatin and fluorouracil (PF) regimen.
Conditions
Interventions
- DRUG
-
nimotuzumab
nimotuzumab 400 mg d1
- DRUG
-
PF regimen (cisplatin and 5-FU)
cisplatin 75 mg/m2 d1 and 5-FU 750 mg/m2/d CIV d1-5
Sponsors & Collaborators
-
Fudan University
lead OTHER
Principal Investigators
-
Ye Guo, MD · Fudan University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-05-31
- Primary Completion
- 2011-12-31
- Completion
- 2011-12-31
Countries
- China
Study Locations
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