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

Locally Advanced Head and Neck Squamous Cell Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01689194
• Other study ID #: CRCST-L-0007
• Secondary ID: H-1204-103-407
• Status: Completed
• Phase: Phase 2
• Start date: February 2013
• Est. completion date: August 31, 2017

Study information

• Verified date: December 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 31, 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Locally Advanced Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• genexolPM + cisplatin

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Clinical Research Center for Solid Tumor, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate	RECIST	every 2 cycles, 6wk later after chemotherapy
Secondary	Locoregional control rate	NCI CTCAE	every 3wk (every cycle)
Secondary	Quality of life	EORTC Q30; performance scale(activities) pain adverse event(appetite, sleep and so on)	every 3wk (every cycle)
Secondary	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	every 3wk (every cycle)