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

Seoul National University Hospital53 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

genexolPM + cisplatinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 (2)

Seoul National University Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

response rate

RECIST

Time frame: every 2 cycles, 6wk later after chemotherapy

Secondary Outcomes

Locoregional control rate

NCI CTCAE

Time frame: every 3wk (every cycle)

Quality of life

EORTC Q30; performance scale(activities) pain adverse event(appetite, sleep and so on)

Time frame: every 3wk (every cycle)

safety

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

Time frame: every 3wk (every cycle)

Data from ClinicalTrials.gov

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