Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma
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ClinicalTrials.gov Identifier: NCT00051545 |
Recruitment Status :
Terminated
First Posted : January 14, 2003
Last Update Posted : February 22, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Liver Neoplasms | Drug: Seocalcitol | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 608 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Educational/Counseling/Training |
Official Title: | 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 |
Study Start Date : | November 1999 |
Study Completion Date : | June 2004 |
- Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic).
- Survival
- Time to distant recurrence of HCC
- Time to second primary HCC
- Time to development of metastases
- Tumour measurements
- Tumour marker (alpha-fetoprotein AFP)
- Quality of life
- Length of hospital stay
- Adverse events
- Laboratory safety examinations
- Dose of Seocalcitol

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051545
Canada, Ontario | |
E.g., University Health Network Toronto General Hospital (numerous facilities in Canada are recruiting) | |
Toronto, Ontario, Canada, M5G2C4 | |
France | |
E.g., Hopital Notre-Dame de Bon Secour, Service de Hepato-gastro-enterologie (numerous facilities are recruiting in France) | |
Metz, France, F-57038 Metz Cedex | |
Italy | |
E.g., Osp. Maggiore, Policlinico di Milano, Divisione di Medicina Interna (numerous facilities are recruiting in Italy) | |
Milano, Italy, I-20 122 | |
Spain | |
E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain) | |
Barcelona, Spain, E-08036 | |
United Kingdom | |
E.g., The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK) | |
Edinburgh, United Kingdom, EH3 9YW |
Study Director: | Hanne Hvidberg, MScPharm PhD | LEO Pharma |
ClinicalTrials.gov Identifier: | NCT00051545 |
Other Study ID Numbers: |
EBC 9802 INT |
First Posted: | January 14, 2003 Key Record Dates |
Last Update Posted: | February 22, 2007 |
Last Verified: | April 2005 |
liver cancer hepatocellular carcinoma |
Carcinoma Carcinoma, Hepatocellular Liver Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Liver Diseases Seocalcitol Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |