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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: |
NCT00116454 |
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Date of registration:
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29/06/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Trial for Hepatocellular Carcinoma Adjuvant Treatment by Lipiocis
Lipiocis |
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Scientific title:
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A Randomized and Multicenter Trial for Hepatocellular Carcinoma Adjuvant Treatment by Lipiocis |
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Date of first enrolment:
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July 2005 |
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Target sample size:
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73 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00116454 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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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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Fabrice Carrat, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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INSERM U 444 FACULTE DE MEDECINE ST ANTOINE |
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Name:
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Olivier Rosmorduc, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hopital Saint Antoine SERVICE D'HEPATOLOGIE |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men or women , aged between 18 and 75 years old
- Cirrhosis or chronic hepatitis associated with C, B, delta infection or alcool intake
or both and confirmed by liver biopsy
- One or two HCC nodules treated by surgical or percutaneous ablation (ethanol, acetic
acid 50% or radiofrequency).
- The efficacy of the initial curative treatment will be assessed by the following
criteria: alpha-fetoprotein concentration < or equal 25ng/ml, no progression in size
of the tumour demonstrated by ultrasonography and no arterial hypervascularization on
CT scan imaging
Exclusion Criteria:
- HIV coinfection associated with a CD count<200/mm3 and a viral charge>5000 HIV RNA
copies/ml
- Documented iodine intolerance
- Respiratory insufficiency
- Decompensated cirrhosis (Child-Pugh score over 8)
- Bilirubin concentration over 51 µmol/l
- Portal or hepatic vein thrombosis
- Extra-hepatic metastasis
- Excessive alcohol intake (over 50g per day)
- Blood platelet count below 50000/mm3
- Neutrophil count above 1500/mm3
- Creatininemia over 120µmol/l
- Myocardial infarction or rhythm disorders
- Psychiatric disease with hospitalization
- Previous treatment for hepatocellular carcinoma
- Pregnant or breastfeeding
- Treatment with interferon and/or ribavirin 3 months before inclusion
- Treatment with tamoxifen or somatostatin analogs or systemic chemotherapy
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Carcinoma, Hepatocellular
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Hepatitis, Viral, Human
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Intervention(s)
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Drug: 131 I-lipiodol
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Primary Outcome(s)
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to determine if the Lipiocis treatment decreases the % of tumoral recurrence after 24 months, judged on the rise of alpha-fetoprotein and the reappearance of one or more tumours on the hepatic CT scan
[Time Frame: at 24 Months]
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Secondary Outcome(s)
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treatment toxicity
[Time Frame: at 24 months]
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overall survival
[Time Frame: at 24 months]
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recurrence-free survival
[Time Frame: at 24 months]
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Deterioration of the hepatocellular function
[Time Frame: at 24 months]
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Secondary ID(s)
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ANRS HC06 LIPIOCIS
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2004-003883-31
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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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