Trial Information
A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Inclusion Criteria:
- locally advanced head and neck squamous cell carcinoma
- oral cavity, oropharynx, hypopharynx, larynx
- measurable lesion
- unresectable
- age 18 or more
- ECOG 0 or 1
Exclusion Criteria:
- distant metastasis
- pregnancy
- prior chemotherapy or radiation therapy
- 2ndary malignancy
- other unfit medical condition
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
response rate
Outcome Description:
RECIST
Outcome Time Frame:
every 2 cycles, 6wk later after chemotherapy
Safety Issue:
No
Principal Investigator
Se-Hoon Lee, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Seoul National University Hospital
Authority:
Korea: Food and Drug Administration
Study ID:
CRCST-L-0007
NCT ID:
NCT01689194
Start Date:
February 2013
Completion Date:
February 2016
Related Keywords:
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- Carcinoma
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms