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Primary Liver CancerPhase 2PRECISIONVNCT00261378

Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation

A Phase 2 study testing Transarterialchemoembolisation (TACE) and DC Bead with Doxorubicin in people with Primary Liver Cancer, run by Boston Scientific Corporation at 17 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary Liver Cancer
What is being tested?
Transarterialchemoembolisation (TACE) and DC Bead with Doxorubicin
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
17 sitesin 4 countries
Study dates
Nov 2005to Jan 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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,
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  • 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,
  • WBC <3000 cells/mm3
  • neutrophil <1500 cells/mm3,
  • cardiac ejection fraction <50 percent assessed by isotopic ventriculography, echocardiography or MRI
  • Any contraindication for hepatic embolisation procedures:
  • porto-systemic shunt,
  • hepatofugal blood flow;
  • impaired clotting tests (platelet count <50000/mm3, prothrombin activity <50 percent),
  • renal insufficiency/failure, serum creatinine > 2mg/dl (177umol/l)
  • severe atheromatosis,
  • AST and/or ALT >5x ULN or, when greater >250U/l
  • Women who are pregnant or breast feeding
  • Allergy to contrast media
  • Contraindication to hepatic artery catheterisation, such as severe peripheral vascular disease precluding catheterisation
  • The availability of alternative therapies those, in the judgment of the physician (referring or treating), are more appropriate for the patient
  • Any co-morbid disease or condition or event that, in the investigator's judgment, would place the patient at undue risk, that would preclude the safe use of DC Bead™, or TACE
  • Patients who are contraindicated for MRI

Trial locations and contacts

17 sites in 4 countries.

17 sites in 4 countries

France7 sites

  • L'Hopital Beaujon

    Clichy, 92100

  • Hopital Claude Huriez

    Lille, 59037

  • Groupement Hospitalier Edouard Herriot

    Lyon, 69437

  • Hopital Archet II

    Nice, 6200

  • Hopital Pitie Salpetriere

    Paris, 75013

  • CHU Rangueil

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany4 sites

  • Klinikum der Johann-Wolfgang-Goethe-Universitat

    Frankfurt am Main, 60590

  • Medicinische Hochschule Hannover

    Hanover, 30625

  • Klinikum der Johannes Guttenberg

    Mainz, 55131

  • Fakultat fur Klinische Medizin Mannheim Universitat

    Mannheim, 68167

Other trials in Germany

Switzerland4 sites

  • Inselspital Bern

    Bern, 3010

  • Hopitaux Universitaires de Geneve

    Geneva, 3010

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011

  • Universitatsspital Zurich

    Zurich, 8091

Other trials in Switzerland

Austria2 sites

  • Medizinische Universitat Innsbruck

    Innsbruck, 6020

  • Allgemines Krankenhaus Vienna

    Vienna, 1090

Other trials in Austria

About this study

Official title: Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation (PRECISION V)

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

Being tested
Transarterialchemoembolisation (TACE), DC Bead with Doxorubicin
Keywords
Hepatocellular Carcinoma (HCC)
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transarterialchemoembolisation (TACE)Device

    Also called Conventional TACE with doxorubicin

  • DC Bead with DoxorubicinDevice

Study groups in NCT00261378
Study groupRoleWhat they receive
Transarterialchemoembolisation (TACE)Active comparatorConventional TACE with doxorubicin
Receives: Device: Transarterialchemoembolisation (TACE)
DC BeadOtherDC Bead with doxorubicin
Receives: Device: DC Bead with Doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate measured according to RECIST and EASL

    Measured: 6 months

Secondary outcomes (10)

  1. Toxicity

    Measured: 6 month

  2. Change in Alpha Fetal Protein (AFP) over time

    Measured: 6 months

  3. Time to hospital discharge

    Measured: 6 months

  4. Safety

    Measured: 6 months

  5. Other procedures or interventions required

    Measured: 6 months

  6. Cardiotoxicity

    Measured: 6 months

  7. Local Tumour Response

    Measured: 6 months

  8. Health care resource use

    Measured: 6 months

  9. Patient quality of life

    Measured: 6 months

  10. Time To Progression

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionJan 2008
  4. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00261378
Sponsor's protocol ID
CA1008
Acronym
PRECISIONV
Status last verified
Jul 2021
First submitted
1 Dec 2005
Last updated
21 Jul 2021
Results posted
No

Publications

  • 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.

    PubMed 21940527

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Transarterialchemoembolisation (TACE) and DC Bead with Doxorubicin in people with Primary Liver Cancer, run by Boston Scientific Corporation at 17 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France, Germany, Switzerland, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate measured according to RECIST and EASL (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00261378, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.

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