Phase II Study of Nimotuzumab Plus PF as Induction Chemotherapy in Patients With Locally Advanced HNSCC
18 Years
70 Years
Both
Head and Neck Cancer
Trial Information
Phase II Study of Nimotuzumab Plus PF as Induction Chemotherapy in Patients With Locally Advanced HNSCC
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. Therefore, we plan to perform a phase II study to evaluate it, focusing
on radiographic and pathologic response after induction chemotherapy. Moreover, a new EGFR
monoclonal antibody (nimotuzumab) is incorporated with PF regimen. The hypothesis is the
addition of nimotuzumab would improve the response without remarkably increase the toxicity.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
overall response rate
Outcome Time Frame:
6 weeks
Safety Issue:
No
Principal Investigator
Ye Guo, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fudan University
Authority:
China: Ethics Committee
Study ID:
HNTG 09-01
NCT ID:
NCT00910117
Start Date:
May 2009
Completion Date:
December 2011
Related Keywords:
- Head and Neck Cancer
- HNSCC
- induction chemotherapy
- nimotuzumab
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
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