Efficacy Study of Genexol-PM and Cisplatin in Locally Advanced Head and Neck Cancer
Conditions
Locally Advanced Head and Neck Squamous Cell Carcinoma
Conditions: official terms
Carcinoma, Squamous Cell - Head and Neck Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: genexolPM + cisplatin
Type: Drug
Overall Status
Recruiting
Summary
This clinical trial is Phase II trial for evaluating efficacy of induction chemotherapy using Genexol-PM + cisplatin for locally advanced head and neck cancer. The investigators try to evaluate response rate of Genexol-PM + cisplatin chemotherapy, and safety profile.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
Seoul National University Hospital
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Bhumsuk Keam, MD - 82-2-2072-7215 - bhumsuk@snu.ac.kr
Seoul National University Hospital
Seoul, Korea, Republic of
Status: Recruiting
Start Date
February 2013
Completion Date
February 2016
Sponsors
Seoul National University Hospital
Source
Seoul National University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page