PRECISIONV: Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation
Study Details
Study Description
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 |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Transarterialchemoembolisation (TACE) Conventional TACE with doxorubicin |
Device: Transarterialchemoembolisation (TACE)
Other Names:
|
| Other: DC Bead DC Bead with doxorubicin |
Device: DC Bead with Doxorubicin
|
Outcome Measures
Primary Outcome Measures
- Objective response rate measured according to RECIST and EASL [6 months]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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
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Age above 18 years old
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Patients with HCC not suitable for resection or percutaneous ablation according to the BCLC Staging classification, see Figure 2.
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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
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Patients with Performance Status ECOG 0 and 1
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Patients with well preserved liver function (Child-Pugh A and B)
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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.
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Advanced liver disease:
-
Child-Pugh C,
-
active gastrointestinal bleeding,
-
encephalopathy or clinically relevant ascites.
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Bilirubin levels >3mg/dl
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Advanced tumoural disease:
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BCLC class C, (vascular invasion including segmental portal obstruction, extrahepatic spread or cancer-related symptoms= ECOG 2, 3 and 4) or
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BCLC class D (WHO performance status 3 or 4, Okuda III stage) or
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Diffuse HCC defined as >50% tumour involvement of the whole liver
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Any contraindication for doxorubicin administration:
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serum bilirubin >5mg/dL,
-
WBC <3000 cells/mm3
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neutrophil <1500 cells/mm3,
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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)
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severe atheromatosis,
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AST and/or ALT >5x ULN or, when greater >250U/l
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Women who are pregnant or breast feeding
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Allergy to contrast media
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Contraindication to hepatic artery catheterisation, such as severe peripheral vascular disease precluding catheterisation
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The availability of alternative therapies those, in the judgment of the physician (referring or treating), are more appropriate for the patient
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medizinische Universitat Innsbruck | Innsbruck | Austria | 6020 | |
| 2 | Allgemines Krankenhaus Vienna | Vienna | Austria | 1090 | |
| 3 | L'Hopital Beaujon | Clichy | France | 92100 | |
| 4 | Hopital Claude Huriez | Lille | France | 59037 | |
| 5 | Groupement Hospitalier Edouard Herriot | Lyon | France | 69437 | |
| 6 | Hopital Archet II | Nice | France | 6200 | |
| 7 | Hopital Pitie Salpetriere | Paris | France | 75013 | |
| 8 | CHU Rangueil | Toulouse | France | 31059 | |
| 9 | Institut Gustave Roussy | Villejuif | France | 94805 | |
| 10 | Klinikum der Johann-Wolfgang-Goethe-Universitat | Frankfurt am Main | Germany | 60590 | |
| 11 | Medicinische Hochschule Hannover | Hannover | Germany | 30625 | |
| 12 | Klinikum der Johannes Guttenberg | Mainz | Germany | 55131 | |
| 13 | Fakultat fur Klinische Medizin Mannheim Universitat | Mannheim | Germany | 68167 | |
| 14 | Inselspital Bern | Bern | Switzerland | 3010 | |
| 15 | Hopitaux Universitaires de Geneve | Geneve | Switzerland | 3010 | |
| 16 | Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland | 1011 | |
| 17 | Universitatsspital Zurich | Zurich | Switzerland | 8091 |
Sponsors and Collaborators
- Boston Scientific Corporation
- Biocompatibles UK Ltd
Investigators
- Principal Investigator: Prof Johannes Lammer, The Allgemines Krankenhaus, Vienna, 1090, Austria
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CA1008