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

Primary Purpose

Locally Advanced Head and Neck Squamous Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
genexolPM + cisplatin
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

genexolPM + cisplatin

Arm Description

Outcomes

Primary Outcome Measures

response rate
RECIST

Secondary Outcome Measures

Locoregional control rate
NCI CTCAE
Quality of life
EORTC Q30; performance scale(activities) pain adverse event(appetite, sleep and so on)
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

Full Information

First Posted
August 30, 2012
Last Updated
December 4, 2020
Sponsor
Seoul National University Hospital
Collaborators
Clinical Research Center for Solid Tumor, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01689194
Brief Title
Efficacy Study of Genexol-PM and Cisplatin in Locally Advanced Head and Neck Cancer
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 2013 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Clinical Research Center for Solid Tumor, Korea

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Head and Neck Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
genexolPM + cisplatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
genexolPM + cisplatin
Primary Outcome Measure Information:
Title
response rate
Description
RECIST
Time Frame
every 2 cycles, 6wk later after chemotherapy
Secondary Outcome Measure Information:
Title
Locoregional control rate
Description
NCI CTCAE
Time Frame
every 3wk (every cycle)
Title
Quality of life
Description
EORTC Q30; performance scale(activities) pain adverse event(appetite, sleep and so on)
Time Frame
every 3wk (every cycle)
Title
safety
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Se-Hoon Lee, MD PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
30796155
Citation
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.
Results Reference
derived

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

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