Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma

NCT00051545 | Terminated Phase 3

• 1 other identifier: EBC 9802 INT
• Study Type: interventional
• Target: 608
• Locations: 5 countries
• Sites: 5

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).

Conditions

Liver Neoplasms

Keywords

liver; cancer; hepatocellular; carcinoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (11)

• Survival

• Time to distant recurrence of HCC

• Time to second primary HCC

• Time to development of metastases

• Tumour measurements

Interventions

Seocalcitol DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospital in- or out patients
• Either sex
• to 75 years of age
• All patients must give their signed informed consent to join the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (5)

E.g., University Health Network Toronto General Hospital (numerous facilities in Canada are recruiting)

Toronto, Ontario, M5G2C4, Canada

Location

E.g., Hopital Notre-Dame de Bon Secour, Service de Hepato-gastro-enterologie (numerous facilities are recruiting in France)

Metz, F-57038 Metz Cedex, France

Location

E.g., Osp. Maggiore, Policlinico di Milano, Divisione di Medicina Interna (numerous facilities are recruiting in Italy)

Milan, I-20 122, Italy

Location

E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain)

Barcelona, E-08036, Spain

Location

E.g., The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK)

Edinburgh, EH3 9YW, United Kingdom

Location

Related Links

• Clinical Trials at LEO Pharma

MeSH Terms

Conditions

Liver Neoplasms; Neoplasms; Carcinoma

Interventions

seocalcitol

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Hanne Hvidberg, MScPharm PhD

  LEO Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 13, 2003
• First Posted: January 14, 2003
• Study Start: November 1, 1999
• Study Completion: June 1, 2004
• Last Updated: February 25, 2025

Record last verified: 2005-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); ES (1); GB (1); CA (1); FR (1)