- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00261378
Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation (PRECISIONV)
July 15, 2021 updated by: Boston Scientific Corporation
Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation (PRECISION V)
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
212
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Innsbruck, Austria, 6020
- Medizinische Universität Innsbruck
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Vienna, Austria, 1090
- Allgemines Krankenhaus Vienna
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Clichy, France, 92100
- L'Hopital Beaujon
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Lille, France, 59037
- Hôpital Claude Huriez
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Lyon, France, 69437
- Groupement Hospitalier Edouard Herriot
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Nice, France, 6200
- Hôpital ARCHET II
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Paris, France, 75013
- Hôpital Pitié Salpêtrière
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Toulouse, France, 31059
- CHU Rangueil
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Villejuif, France, 94805
- Institut Gustave Roussy
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Frankfurt am Main, Germany, 60590
- Klinikum der Johann-Wolfgang-Goethe-Universität
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Hannover, Germany, 30625
- Medicinische Hochschule Hannover
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Mainz, Germany, 55131
- Klinikum der Johannes Guttenberg
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Mannheim, Germany, 68167
- Fakultat fur Klinische Medizin Mannheim Universitat
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Bern, Switzerland, 3010
- Inselspital Bern
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Geneve, Switzerland, 3010
- Hôpitaux universitaires de Genève
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Lausanne, Switzerland, 1011
- Centre Hospitalier Universitaire Vaudois
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Zurich, Switzerland, 8091
- Universitatsspital Zurich
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Transarterialchemoembolisation (TACE)
Conventional TACE with doxorubicin
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Other Names:
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Other: DC Bead
DC Bead with doxorubicin
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Objective response rate measured according to RECIST and EASL
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Toxicity
Time Frame: 6 month
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6 month
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Change in Alpha Fetal Protein (AFP) over time
Time Frame: 6 months
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6 months
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Time to hospital discharge
Time Frame: 6 months
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6 months
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Safety
Time Frame: 6 months
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6 months
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Other procedures or interventions required
Time Frame: 6 months
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6 months
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Cardiotoxicity
Time Frame: 6 months
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6 months
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Local Tumour Response
Time Frame: 6 months
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6 months
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Health care resource use
Time Frame: 6 months
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6 months
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Patient quality of life
Time Frame: 6 months
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6 months
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Time To Progression
Time Frame: 6 months
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Prof Johannes Lammer, The Allgemines Krankenhaus, Vienna, 1090, Austria
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
December 1, 2005
First Submitted That Met QC Criteria
December 1, 2005
First Posted (Estimate)
December 5, 2005
Study Record Updates
Last Update Posted (Actual)
July 21, 2021
Last Update Submitted That Met QC Criteria
July 15, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Doxorubicin
- Liposomal doxorubicin
Other Study ID Numbers
- CA1008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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