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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00261378
Recruitment Status : Completed
First Posted : December 5, 2005
Last Update Posted : June 15, 2010
Information provided by:
Biocompatibles UK Ltd

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation (PRECISION V)
Study Start Date : November 2005
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Objective response rate measured according to RECIST and EASL [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 6 month ]
  2. Change in Alpha Fetal Protein (AFP) over time [ Time Frame: 6 months ]
  3. Time to hospital discharge [ Time Frame: 6 months ]
  4. Safety [ Time Frame: 6 months ]
  5. Other procedures or interventions required [ Time Frame: 6 months ]
  6. Cardiotoxicity [ Time Frame: 6 months ]
  7. Local Tumour Response [ Time Frame: 6 months ]
  8. Health care resource use [ Time Frame: 6 months ]
  9. Patient quality of life [ Time Frame: 6 months ]
  10. Time To Progression [ Time Frame: 6 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00261378

Medizinische Universitat Innsbruck
Innsbruck, Austria, 6020
Allgemines Krankenhaus Vienna
Vienna, Austria, 1090
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
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
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
Principal Investigator: Prof Johannes Lammer The Allgemines Krankenhaus, Vienna, 1090, Austria

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Clinical Research Director Identifier: NCT00261378     History of Changes
Other Study ID Numbers: CA1008
First Posted: December 5, 2005    Key Record Dates
Last Update Posted: June 15, 2010
Last Verified: June 2010

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

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