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

This study has been completed.
Sponsor:
Information provided by:
Biocompatibles UK Ltd
ClinicalTrials.gov Identifier:
NCT00261378
First received: December 1, 2005
Last updated: June 14, 2010
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Primary Liver Cancer
Device: Transarterialchemoembolisation (TACE)
Device: DC Bead with Doxorubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation (PRECISION V)

Resource links provided by NLM:


Further study details as provided by Biocompatibles UK Ltd:

Primary Outcome Measures:
  • Objective response rate measured according to RECIST and EASL [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • Change in Alpha Fetal Protein (AFP) over time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Time to hospital discharge [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Other procedures or interventions required [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Cardiotoxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Local Tumour Response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Health care resource use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patient quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Time To Progression [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 212
Study Start Date: November 2005
Study Completion Date: January 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261378

Locations
Austria
Medizinische Universitat Innsbruck
Innsbruck, Austria, 6020
Allgemines Krankenhaus Vienna
Vienna, Austria, 1090
France
L'Hopital Beaujon
Clichy, France, 92100
Hopital Claude Huriez
Lille, France, 59037
Groupement Hospitalier Edouard Herriot
Lyon, France, 69437
Hopital Archet II
Nice, France, 6200
Hopital Pitie Salpetriere
Paris, France, 75013
CHU Rangueil
Toulouse, France, 31059
Institut Gustave Roussy
Villejuif, France, 94805
Germany
Klinikum der Johann-Wolfgang-Goethe-Universitat
Frankfurt am Main, Germany, 60590
Medicinische Hochschule Hannover
Hannover, Germany, 30625
Klinikum der Johannes Guttenberg
Mainz, Germany, 55131
Fakultat fur Klinische Medizin Mannheim Universitat
Mannheim, Germany, 68167
Switzerland
Inselspital Bern
Bern, Switzerland, 3010
Hopitaux Universitaires de Geneve
Geneve, Switzerland, 3010
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Universitatsspital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
Biocompatibles UK Ltd
Investigators
Principal Investigator: Prof Johannes Lammer The Allgemines Krankenhaus, Vienna, 1090, Austria
  More Information

No publications provided by Biocompatibles UK Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinical Research Director
ClinicalTrials.gov Identifier: NCT00261378     History of Changes
Other Study ID Numbers: CA1008
Study First Received: December 1, 2005
Last Updated: June 14, 2010
Health Authority: Austria: Federal Ministry for Social Security and Generations, Vienna, Austria
Germany: Ethics Commission
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Biocompatibles UK Ltd:
Hepatocellular Carcinoma (HCC)

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma, Hepatocellular
Carcinoma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014