Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma
This study has been terminated.
Sponsor:
LEO Pharma
Information provided by:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00051545
First received: January 13, 2003
Last updated: February 21, 2007
Last verified: April 2005
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Purpose
To evaluate the efficacy of Seocalcitol in prolonging time to relapse following intended curative resection or percutaneous ablative treatment, i.e. percutaneous ethanol injection(s), percutaneous acetic acid injection(s), percutaneous microwave coagulation therapy, or percutaneous radiofrequency ablation for hepatocellular carcinoma (HCC).
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Neoplasms |
Drug: Seocalcitol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
Further study details as provided by LEO Pharma:
Primary Outcome Measures:
- Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic).
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 608 |
| Study Start Date: | November 1999 |
| Estimated Study Completion Date: | June 2004 |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00051545
Please refer to this study by its ClinicalTrials.gov identifier: NCT00051545
Locations
| 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 | |
Sponsors and Collaborators
LEO Pharma
Investigators
| Study Director: | Hanne Hvidberg, MScPharm PhD | LEO Pharma |
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00051545 History of Changes |
| Other Study ID Numbers: | EBC 9802 INT |
| Study First Received: | January 13, 2003 |
| Last Updated: | February 21, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by LEO Pharma:
|
liver cancer hepatocellular carcinoma |
Additional relevant MeSH terms:
|
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 Calcitriol |
Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Vitamins Micronutrients Growth Substances Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on September 23, 2016