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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: |
NCT01088581 |
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Date of registration:
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16/03/2010 |
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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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Adjuvant Hepatic Arterial Infusional Chemotherapy After Curative Resection of Hepatocellular Carcinoma
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Scientific title:
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Adjuvant Hepatic Arterial Infusional Chemotherapy With 5-fluorouracil and Cisplatin After Curative Resection of Hepatocellular Carcinoma: A Prospective Randomized Study |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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101 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01088581 |
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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: Double Blind (Subject, Investigator), 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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Korea, Republic of
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Contacts
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Name:
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Seung Up Kim, 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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Yonsei University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age of 18 to 70 years old
- appropriate blood test results (white blood cells (WBCs) =3,000/mm3, platelet count
=50,000/mm3, total bilirubin <3mg/dl)
- a patient could enter this study if one of the following was fulfilled
1. maximum diameter of HCC =5 cm,
2. microvascular or bile duct invasion upon pathological examination,
3. capsular invasion of HCC upon pathological examination, 4) Edmonson-Steiner
grade III or IV.
Exclusion Criteria:
- patients with intra- or extrahepatic metastases at 4 weeks after resection
- Child-Pugh class B or C (n = 4)
- ECOG performance scale =2
- prior systemic chemotherapy, radiation, or locoregional therapy
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatocellular Carcinoma
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Intervention(s)
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Drug: Adjuvant group
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Primary Outcome(s)
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2-year recurrence rate and adverse events
[Time Frame: 2-year]
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Secondary Outcome(s)
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overall survival
[Time Frame: 2-year]
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Secondary ID(s)
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4-2005-0203
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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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