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

December 4, 2020 updated by: Se-Hoon Lee, Seoul National University Hospital

A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: genexolPM + cisplatin
Drug: genexolPM + cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response rate
Time Frame: every 2 cycles, 6wk later after chemotherapy
RECIST
every 2 cycles, 6wk later after chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Locoregional control rate
Time Frame: every 3wk (every cycle)
NCI CTCAE
every 3wk (every cycle)
Quality of life
Time Frame: every 3wk (every cycle)
EORTC Q30; performance scale(activities) pain adverse event(appetite, sleep and so on)
every 3wk (every cycle)
safety
Time Frame: every 3wk (every cycle)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Clinical Research Center for Solid Tumor, Korea

Investigators

  • Principal Investigator: Se-Hoon Lee, MD PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

August 30, 2012

First Submitted That Met QC Criteria

September 20, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Actual)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 4, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRCST-L-0007
  • H-1204-103-407 (Other Identifier: SNUH IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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