NCT00261378

Brief Summary

The objective of this study is to assess the safety and efficacy of DC Bead™ delivered by intra-arterial embolisation for the treatment of Hepatocellular Carcinoma

Trial Health

90
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2005

Geographic Reach
4 countries

17 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

Study Start

First participant enrolled

November 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

2.2 years

First QC Date

December 1, 2005

Last Update Submit

July 15, 2021

Conditions

Primary Liver Cancer

Keywords

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

  • Objective response rate measured according to RECIST and EASL

    6 months

Secondary Outcomes (10)

  • Toxicity

    6 month

  • Change in Alpha Fetal Protein (AFP) over time

    6 months

  • Time to hospital discharge

    6 months

  • Safety

    6 months

  • Other procedures or interventions required

    6 months

  • +5 more secondary outcomes

Study Arms (2)

Transarterialchemoembolisation (TACE)

ACTIVE COMPARATOR

Conventional TACE with doxorubicin

Device: Transarterialchemoembolisation (TACE)

DC Bead

OTHER

DC Bead with doxorubicin

Device: DC Bead with Doxorubicin

Interventions

Transarterialchemoembolisation (TACE)DEVICE
Also known as: Conventional TACE with doxorubicin
Transarterialchemoembolisation (TACE)
DC Bead with DoxorubicinDEVICE
DC Bead

Eligibility Criteria

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

You may qualify if:

  • Patients with a confirmed diagnosis of HCC according to the EASL criteria for diagnosis, see appendix 4 and staged according to the BCLC criteria.
  • Patient chooses to participate and has signed the informed consent document
  • Age above 18 years old
  • Patients with HCC not suitable for resection or percutaneous ablation according to the BCLC Staging classification, see Figure 2.
  • Patient is eligible for resection or percutaneous ablation but the treatment is unfeasible or the patient has declined. This decision must be documented in the patient's records.
  • Patient is eligible for chemoembolisation prior to transplantation and the expected transplant waiting time exceeds 6 months.
  • Patients who demonstrates recurrence following potentially curative treatment (resection and percutaneous ablation) who have clearly measurable disease according to RECIST or EASL
  • Patients with Performance Status ECOG 0 and 1
  • Patients with well preserved liver function (Child-Pugh A and B)
  • Patients with bilobar disease who can be treated superselectively in a single session or both lobes able to be treated within 3 weeks.

You may not qualify if:

  • Patients with another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia
  • Patients previously treated with transarterial embolisation (with or without chemotherapy).
  • Patients previously treated with anthracyclines (ie doxorubicin).
  • Patients' whose only measurable disease is within an area of the liver previously subjected to radiotherapy.
  • Advanced liver disease:
  • Child-Pugh C,
  • active gastrointestinal bleeding,
  • encephalopathy or clinically relevant ascites.
  • Bilirubin levels \>3mg/dl
  • Advanced tumoural disease:
  • BCLC class C, (vascular invasion including segmental portal obstruction, extrahepatic spread or cancer-related symptoms= ECOG 2, 3 and 4) or
  • BCLC class D (WHO performance status 3 or 4, Okuda III stage) or
  • Diffuse HCC defined as \>50% tumour involvement of the whole liver
  • Any contraindication for doxorubicin administration:
  • serum bilirubin \>5mg/dL,
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Medizinische Universitat Innsbruck

Innsbruck, 6020, Austria

Location

Allgemines Krankenhaus Vienna

Vienna, 1090, Austria

Location

L'Hopital Beaujon

Clichy, 92100, France

Location

Hopital Claude Huriez

Lille, 59037, France

Location

Groupement Hospitalier Edouard Herriot

Lyon, 69437, France

Location

Hopital Archet II

Nice, 6200, France

Location

Hopital Pitie Salpetriere

Paris, 75013, France

Location

CHU Rangueil

Toulouse, 31059, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Klinikum der Johann-Wolfgang-Goethe-Universitat

Frankfurt am Main, 60590, Germany

Location

Medicinische Hochschule Hannover

Hanover, 30625, Germany

Location

Klinikum der Johannes Guttenberg

Mainz, 55131, Germany

Location

Fakultat fur Klinische Medizin Mannheim Universitat

Mannheim, 68167, Germany

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Hopitaux Universitaires de Geneve

Geneva, 3010, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

Universitatsspital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Vogl TJ, Lammer J, Lencioni R, Malagari K, Watkinson A, Pilleul F, Denys A, Lee C. Liver, gastrointestinal, and cardiac toxicity in intermediate hepatocellular carcinoma treated with PRECISION TACE with drug-eluting beads: results from the PRECISION V randomized trial. AJR Am J Roentgenol. 2011 Oct;197(4):W562-70. doi: 10.2214/AJR.10.4379.

    PMID: 21940527DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

  • Prof Johannes Lammer

    The Allgemines Krankenhaus, Vienna, 1090, Austria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2005

First Posted

December 5, 2005

Study Start

November 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

July 21, 2021

Record last verified: 2021-07

Locations

DE(4)AU(2)FR(7)CH(4)