NCT01689194

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2013

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

3.2 years

First QC Date

August 30, 2012

Last Update Submit

December 4, 2020

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • response rate

    RECIST

    every 2 cycles, 6wk later after chemotherapy

Secondary Outcomes (3)

  • Locoregional control rate

    every 3wk (every cycle)

  • Quality of life

    every 3wk (every cycle)

  • safety

    every 3wk (every cycle)

Study Arms (1)

genexolPM + cisplatin

EXPERIMENTAL
Drug: genexolPM + cisplatin

Interventions

genexolPM + cisplatinDRUG
genexolPM + cisplatin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • locally advanced head and neck squamous cell carcinoma
  • oral cavity, oropharynx, hypopharynx, larynx
  • measurable lesion
  • unresectable
  • age 18 or more
  • ECOG 0 or 1

You may not qualify if:

  • distant metastasis
  • pregnancy
  • prior chemotherapy or radiation therapy
  • ndary malignancy
  • other unfit medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 30796155DERIVED

MeSH Terms

Interventions

Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Se-Hoon Lee, MD PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 21, 2012

Study Start

February 1, 2013

Primary Completion

April 1, 2016

Study Completion

August 31, 2017

Last Updated

December 8, 2020

Record last verified: 2020-12

Locations

KR(2)