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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: |
NCT00051545 |
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Date of registration:
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13/01/2003 |
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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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Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma
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Scientific title:
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Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma. Efficacy of Seocalcitol (EB 1089) Enteric-Coated Capsules (5 ug) or Placebo in Prolonging Time to Relapse Following Intended Curative Resection or Percutaneous Ablative Treatment for Hepatocellular Carcinoma |
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Date of first enrolment:
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November 1999 |
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Target sample size:
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608 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00051545 |
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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, Primary Purpose: Educational/Counseling/Training
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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France
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Italy
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Spain
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United Kingdom
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Contacts
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Name:
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Hanne Hvidberg, MScPharm PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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LEO Pharma |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Hospital in- or out patients
- Either sex
- 18 to 75 years of age
- With hepatocellular carcinoma treated successfully with surgical resection or
percutaneous ablative treatment within 4 and 8 weeks, respectively, prior to
inclusion.
- All patients must give their signed informed consent to join the study.
Exclusion Criteria:
- Patients previously treated with any anti-cancer therapy for HCC except for surgical
resection and percutaneous ablative therapy
- Patients treated with chemotherapy or other anti-cancer therapy (except surgical
resection or percutaneous ablative treatment) in the previous 4 weeks
- Patients with another primary tumor except basocellular carcinoma of the skin or in
situ carcinoma of the cervix within the last 2 years
- With a history of renal stone(s)
- With a life expectancy < 3 months
- WHO performance status 3 or 4.
- Patients with hypercalcemia (ionised serum calcium > 1.35 mmol/l or albumin corrected
serum calcium > 2.68 mmol/l), previous/current calcium metabolic disease, taking
calcium-lowering therapy or medication known to affect systemic calcium metabolism,
or with marked laboratory abnormalities.
- Patients with recurrent hepatocellular carcinoma, with known extrahepatic metastases,
Okuda stage III disease and patients with a Child-Pugh score of C are also excluded.
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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Liver Neoplasms
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Intervention(s)
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Drug: Seocalcitol
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Primary Outcome(s)
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Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic).
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Secondary Outcome(s)
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Length of hospital stay
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Time to distant recurrence of HCC
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Time to second primary HCC
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Tumour marker (alpha-fetoprotein AFP)
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Adverse events
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Survival
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Time to development of metastases
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Laboratory safety examinations
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Tumour measurements
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Dose of Seocalcitol
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Quality of life
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Secondary ID(s)
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EBC 9802 INT
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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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