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

NCT ID: NCT01689194

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Locally Advanced Head and Neck Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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genexolPM + cisplatin

Group Type EXPERIMENTAL

genexolPM + cisplatin

Intervention Type DRUG

Interventions

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genexolPM + cisplatin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Research Center for Solid Tumor, Korea

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Se-Hoon Lee

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Se-Hoon Lee, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Keam B, Lee KW, Lee SH, Kim JS, Kim JH, Wu HG, Eom KY, Kim S, Ahn SH, Chung EJ, Kwon SK, Jeong WJ, Jung YH, Kim JW, Heo DS. A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma. Oncologist. 2019 Jun;24(6):751-e231. doi: 10.1634/theoncologist.2019-0070. Epub 2019 Feb 22.

Reference Type DERIVED
PMID: 30796155 (View on PubMed)

Other Identifiers

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H-1204-103-407

Identifier Type: OTHER

Identifier Source: secondary_id

CRCST-L-0007

Identifier Type: -

Identifier Source: org_study_id