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

Primary Liver Cancer Clinical Trial

— PRECISIONV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261378
• Other study ID #: CA1008
• Status: Completed
• Phase: Phase 2
• Start date: November 2005
• Est. completion date: January 2008

Study information

• Verified date: July 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Primary Liver Cancer

Intervention

Device:
• Transarterialchemoembolisation (TACE)

• DC Bead with Doxorubicin

Locations

Country	Name	City	State
Austria	Medizinische Universitat Innsbruck	Innsbruck
Austria	Allgemines Krankenhaus Vienna	Vienna
France	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
Germany	Klinikum der Johann-Wolfgang-Goethe-Universitat	Frankfurt am Main
Germany	Medicinische Hochschule Hannover	Hannover
Germany	Klinikum der Johannes Guttenberg	Mainz
Germany	Fakultat fur Klinische Medizin Mannheim Universitat	Mannheim
Switzerland	Inselspital Bern	Bern
Switzerland	Hopitaux Universitaires de Geneve	Geneve
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Universitatsspital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	Biocompatibles UK Ltd

Countries where clinical trial is conducted

Austria,  France,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate measured according to RECIST and EASL		6 months
Secondary	Toxicity		6 month
Secondary	Change in Alpha Fetal Protein (AFP) over time		6 months
Secondary	Time to hospital discharge		6 months
Secondary	Safety		6 months
Secondary	Other procedures or interventions required		6 months
Secondary	Cardiotoxicity		6 months
Secondary	Local Tumour Response		6 months
Secondary	Health care resource use		6 months
Secondary	Patient quality of life		6 months
Secondary	Time To Progression		6 months