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

NCT ID: NCT00261378

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2008-01-31

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

Conditions

Primary Liver Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Transarterialchemoembolisation (TACE)

Conventional TACE with doxorubicin

Group Type: ACTIVE_COMPARATOR

Transarterialchemoembolisation (TACE)

Intervention Type: DEVICE

DC Bead

DC Bead with doxorubicin

Group Type: OTHER

DC Bead with Doxorubicin

Intervention Type: DEVICE

Interventions

Transarterialchemoembolisation (TACE)

Intervention Type: DEVICE

DC Bead with Doxorubicin

Intervention Type: DEVICE

Other Intervention Names

Conventional TACE with doxorubicin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocompatibles UK Ltd

INDUSTRY

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof Johannes Lammer

Role: PRINCIPAL_INVESTIGATOR

The Allgemines Krankenhaus, Vienna, 1090, Austria

Locations

Medizinische Universitat Innsbruck

Innsbruck, , Austria

Allgemines Krankenhaus Vienna

Vienna, , Austria

L'Hopital Beaujon

Clichy, , France

Hopital Claude Huriez

Lille, , France

Groupement Hospitalier Edouard Herriot

Lyon, , France

Hopital Archet II

Nice, , France

Hopital Pitie Salpetriere

Paris, , France

CHU Rangueil

Toulouse, , France

Institut Gustave Roussy

Villejuif, , France

Klinikum der Johann-Wolfgang-Goethe-Universitat

Frankfurt am Main, , Germany

Medicinische Hochschule Hannover

Hanover, , Germany

Klinikum der Johannes Guttenberg

Mainz, , Germany

Fakultat fur Klinische Medizin Mannheim Universitat

Mannheim, , Germany

Inselspital Bern

Bern, , Switzerland

Hopitaux Universitaires de Geneve

Geneva, , Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Universitatsspital Zurich

Zurich, , Switzerland

Countries

Austria; France; Germany; Switzerland

References

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.

Reference Type: DERIVED

PMID: 21940527 (View on PubMed)

Other Identifiers

CA1008

Identifier Type: -

Identifier Source: org_study_id