Overview

Induction Chemotherapy With Nimotuzumab in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fudan University
Treatments:
Cisplatin
Nimotuzumab
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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