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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01040559 |
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Date of registration:
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28/12/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas
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Scientific title:
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Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas Combining DC Bead Microspheres Loaded With Idarubicin (Zavedos®): Phase I Trial |
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Date of first enrolment:
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December 2009 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01040559 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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France
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Contacts
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Name:
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Laurent BEDENNE, MD Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Universitaire de DIJON |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Hepatocellular carcinoma cytologically or histologically proved or diagnosed
according the criteria of the American Association for the Study of Liver
Diseases(AASLD 2005)
- Three nodules maximum (unilobar disease without limitation in the number of nodules;
3 maximum nodules if bilobar disease [satellite nodules <1cm not included in the
total sum])
- Child-Pugh score A or B7
- ECOG Performance Status < 2
- Platelet count > 50,000/µl and absolute neutrophil count (ANC) >1,000/µl
- Serum creatinine < 150 µmol/l
- Resting ejection fraction > 50% (echocardiography or isotopic method)
- Age > 18 years
- Signed written informed consent
Exclusion Criteria:
- Patients eligible for surgical resection or hepatic transplantation or radiofrequency
ablation
- Extrahepatic metastases
- Known gastrointestinal bleeding up to 30 days before study entry
- Patients with anticoagulant treatment
- Evidence of portal vein thrombosis
- Pregnancy
- Clinically serious infection
- Known hypersensitivity to anthracyclines
- Known hypersensitivity to contrast medium
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Carcinoma, Hepatocellular
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Intervention(s)
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Drug: idarubicin
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Primary Outcome(s)
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Dose-limiting toxicity assessed according NCI CTC AE v3.0
[Time Frame: Within the first month after chemoembolization]
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Secondary Outcome(s)
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Quality of life (EORTC QLQ-C30)
[Time Frame: 2 months]
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Pharmacokinetics parameters of idarubicin and idarubicinol
[Time Frame: Within 72 hours after chemioembolization]
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Objective responses according criteria of the European Association for the Study of the Liver and according RECIST criteria.
[Time Frame: 2 months]
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Secondary ID(s)
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IDASPHERE
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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