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

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

Study Overview

• Status: Completed
• Conditions: Primary Liver Cancer
• Intervention / Treatment: Device: Transarterialchemoembolisation (TACE); Device: DC Bead with Doxorubicin

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Medizinische Universität Innsbruck
  • Vienna, Austria, 1090
    • Allgemines Krankenhaus Vienna
• France
  • Clichy, France, 92100
    • L'Hopital Beaujon
  • Lille, France, 59037
    • Hôpital Claude Huriez
  • Lyon, France, 69437
    • Groupement Hospitalier Edouard Herriot
  • Nice, France, 6200
    • Hôpital ARCHET II
  • Paris, France, 75013
    • Hôpital Pitie Salpétrière
  • Toulouse, France, 31059
    • CHU Rangueil
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Germany
  • Frankfurt am Main, Germany, 60590
    • Klinikum der Johann-Wolfgang-Goethe-Universität
  • Hannover, Germany, 30625
    • Medicinische Hochschule Hannover
  • Mainz, Germany, 55131
    • Klinikum der Johannes Guttenberg
  • Mannheim, Germany, 68167
    • Fakultat fur Klinische Medizin Mannheim Universitat
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern
  • Geneve, Switzerland, 3010
    • Hopitaux Universitaires de Geneve
  • Lausanne, Switzerland, 1011
    • Centre Hospitalier Universitaire Vaudois
  • Zurich, Switzerland, 8091
    • Universitätsspital Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

• 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.

Exclusion criteria

• 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,
  • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transarterialchemoembolisation (TACE); Conventional TACE with doxorubicin	Device: Transarterialchemoembolisation (TACE); Other Names: Conventional TACE with doxorubicin
Other: DC Bead; DC Bead with doxorubicin	Device: DC Bead with Doxorubicin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective response rate measured according to RECIST and EASL	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Cardiotoxicity	6 months
Local Tumour Response	6 months
Health care resource use	6 months
Patient quality of life	6 months
Time To Progression	6 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Collaborators: Biocompatibles UK Ltd
• Investigators: Principal Investigator: Prof Johannes Lammer, The Allgemines Krankenhaus, Vienna, 1090, Austria

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: December 1, 2005
• First Submitted That Met QC Criteria: December 1, 2005
• First Posted (Estimate): December 5, 2005

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma (HCC)
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Doxorubicin; Liposomal doxorubicin
• Other Study ID Numbers: CA1008