Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Liver Neoplasms	Drug: Seocalcitol	Phase 3

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic).

Secondary Outcome Measures :

1. Survival
2. Time to distant recurrence of HCC
3. Time to second primary HCC
4. Time to development of metastases
5. Tumour measurements
6. Tumour marker (alpha-fetoprotein AFP)
7. Quality of life
8. Length of hospital stay
9. Adverse events
10. Laboratory safety examinations
11. Dose of Seocalcitol

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Click here for more information about this study: Drug Development, Pipeline, Seocalcitol 

ClinicalTrials.gov Identifier:	NCT00051545 History of Changes
Other Study ID Numbers:	EBC 9802 INT
First Posted:	January 14, 2003
Last Update Posted:	February 22, 2007
Last Verified:	April 2005

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