Status:
COMPLETED
Induction Chemotherapy With Nimotuzumab in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Lead Sponsor:
Fudan University
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 combina...
Detailed Description
Induction chemotherapy followed by radiotherapy is the standard treatment for patients with unresectable HNSCC. However, the role of induction chemotherapy remains uncertain for resectable disease. Th...
Eligibility Criteria
Inclusion
- Age range 18-70 years old
- ECOG performance status 0-1
- Histologically confirmed and potentially resectable locally advanced (T2-4, N0-3, M0) HNSCC
- Adequate organ function
Exclusion
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Pregnant or lactating women
- Serious uncontrolled diseases and intercurrent infection
- Previous serious cardiac disease
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00910117
Start Date
May 1 2009
End Date
December 1 2011
Last Update
February 20 2012
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032