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

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma

Treatments: Drug: genexolPM + cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01689194

CRCST-L-0007

H-1204-103-407 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

genexolPM + cisplatin

Experimental group

Treatment:

Drug: genexolPM + cisplatin