This trial is active, not recruiting.

Condition locally advanced head and neck squamous cell carcinoma
Treatment genexolpm + cisplatin
Phase phase 2
Sponsor Seoul National University Hospital
Collaborator Clinical Research Center for Solid Tumor, Korea
Start date February 2013
End date April 2016
Trial size 53 participants
Trial identifier NCT01689194, CRCST-L-0007, H-1204-103-407


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
genexolpm + cisplatin

Primary Outcomes

response rate
time frame: every 2 cycles, 6wk later after chemotherapy

Secondary Outcomes

Locoregional control rate
time frame: every 3wk (every cycle)
Quality of life
time frame: every 3wk (every cycle)
time frame: every 3wk (every cycle)

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Principal investigator Se-Hoon Lee, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.