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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: |
NCT00870558 |
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Date of registration:
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26/03/2009 |
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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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Iodine I 131 Ethiodized Oil in Preventing Recurrent Cancer in Patients Who Have Undergone Treatment for Liver Cancer
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Scientific title:
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Adjuvant Treatment by Intra-arterial Injection of Lipiodol-labeled Iodine-131 in Preventing Recurrence of Hepatocellular Carcinoma After Curative Treatment |
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Date of first enrolment:
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June 2005 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00870558 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, 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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Jerome Dumortier, 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 Edouard Herriot - Lyon |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Diagnosis of hepatocellular carcinoma (HCC)
- Alpha-fetoprotein < 20 ng/mL
- Must have undergone curative treatment for HCC within the past 8-20 weeks, including
1 of the following:
- Curative resection
- Alcohol ablation, radiofrequency ablation, or cryotherapy (for 1 or 2 nodules <
5 cm in diameter)
- No ascites
- No other intrahepatic involvement or nodule progression as assessed by ultrasound
- No extrahepatic metastases
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- ANC = 1,500/mm³
- Platelet count = 50,000/mm³
- Bilirubin = 51 µmol/L
- Creatinine = 120 µmol/L
- Not pregnant or nursing
- Negative pregnancy test
- Child-Pugh score < 8 (class B)
- No decompensated cirrhosis
- No encephalopathy
- No uncontrolled bleeding
- No portal thrombosis, right- or left-branch thrombosis, extrahepatic thrombosis, or
portal reflux by doppler or CT scan
- No unstable medical or surgical disease
- No contraindication to vascular arteriography
- No history of complications after injection of iodine contrast agents
- Not incarcerated
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior therapy
- No prior hormonal treatment, including tamoxifen and somatostatin analogs
- No prior systemic chemotherapy
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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Liver Cancer
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Intervention(s)
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Drug: ethiodized oil
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Radiation: iodine I 131 ethiodized oil
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Primary Outcome(s)
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Tumor recurrence at 2 years
[Time Frame: No]
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Secondary ID(s)
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HCL-2004-348-3
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HCL-LIPIODOL
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CDR0000626727
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INCA-RECF0436
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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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