NCT01677468

Brief Summary

The aim of this study was to evaluate whether survival of patients who underwent TACE with unresectable HCC can benefit from intermediate-levels of embolization.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

3 active sites

Status
unknown

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

Study Start

First participant enrolled

August 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2012

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

2.9 years

First QC Date

August 9, 2012

Last Update Submit

August 29, 2012

Conditions

Hepatocellular CarcinomaTransarterial Chemoembolization

Keywords

Hepatocellular carcinomaTransarterial chemoembolization

Outcome Measures

Primary Outcomes (4)

  • Survival rate of the subjects

    Survival rate of the subjects 6 months after TACE

    6 months after TACE

  • Survival rate of the subjects

    Survival rate of the subjects, 12 months after TACE

    12 months after TACE

  • Survival rate of the subjects

    Survival rate of the subjects, 18 months after TACE

    18 months after TACE

  • Survival rate of the subjects

    Survival rate of the subjects, 24 months after TACE

    24 months after TACE

Secondary Outcomes (2)

  • Disease free survival of the subjects

    6, 12, 18, and 24 months after TACE

  • Complication rate of TACE

    6, 12, 18, and 24 months after TACE

Study Arms (2)

Intermediate embolization

EXPERIMENTAL

TACE with substatsis using gelfoam

Procedure: Intermediate embolization

Complete embolization

ACTIVE COMPARATOR

TACE with complete embolization using gelfoam

Procedure: Complete embolization

Interventions

Intermediate embolizationPROCEDURE

TACE with substasis using gelfoam

Also known as: Adriamycin, Cysplatin, Gelfoam
Intermediate embolization
Complete embolizationPROCEDURE

TACE with complete embolization using gelfoam

Also known as: Adriamycin, Cysplatin, Gelfoam
Complete embolization

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age over 18
  • ECOG performance status 0-2
  • Hepatocellular carcinoma diagnosed histologically or clinically
  • Tumor numbers of 5 or less
  • No history of treatment for hepatocellular carcinoma
  • Patients with informed consent

You may not qualify if:

  • Extrahepatic metastasis
  • Rupture of hepatocellular carcinoma
  • Infiltrative hepatocellular carcinoma
  • Malignancy other than hepatocellular carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hallym Sacred Heart Hospital

Anyang, 431070, South Korea

RECRUITING

Chuncheon Sacred Heart Hospital

Chuncheon, 200060, South Korea

RECRUITING

Kangnam Sacred Heart Hostpita

Seoul, 150950, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

DoxorubicinGelatin Sponge, Absorbable

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesSurgical SpongesSurgical EquipmentEquipment and Supplies

Study Officials

  • Sang Hoon Park, M.D., Ph.D.

    Hallym University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Hoon Park, M.D., Ph.D.

CONTACT

82-2-829-5493dr.sanghoon.park@gmail.com

Su Rin Shin, M.D.

CONTACT

82-2-829-5490dr.goforit@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2012

First Posted

September 3, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 3, 2012

Record last verified: 2012-08

Locations

KR(3)