Efficacy Study of Genexol-PM and Cisplatin in Locally Advanced Head and Neck Cancer

A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01689194

Enrollment

Registered

2012-09-21

Start date

2013-02-28

Completion date

2017-08-31

Last updated

2020-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Brief 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.

Interventions

DRUGgenexolPM + cisplatin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
response rate	every 2 cycles, 6wk later after chemotherapy	RECIST

Secondary

Measure	Time frame	Description
Locoregional control rate	every 3wk (every cycle)	NCI CTCAE
Quality of life	every 3wk (every cycle)	EORTC Q30; performance scale(activities) pain adverse event(appetite, sleep and so on)
safety	every 3wk (every cycle)	NCI CTCAE v3.0; disease or syndrome, pathologic funtion, sign or symptom, imjury or poisoning, anatomical abnormality, mental or behavioral dysfunction Neutropenia, leucopenia, thrombocytopenia, hepatotoxicity, renal toxicity

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026