Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma

NCT ID: NCT00051545

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 608 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-11-30
• Study Completion Date: 2004-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Interventions

Seocalcitol

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Principal Investigators

Hanne Hvidberg, MScPharm PhD

Role: STUDY_DIRECTOR

LEO Pharma

Locations

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

Toronto, Ontario, Canada

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

Metz, , France

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

Milan, , Italy

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

Barcelona, , Spain

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

Edinburgh, , United Kingdom

Countries

Canada; France; Italy; Spain; United Kingdom

Related Links

https://www.leopharmatrials.com/en

Clinical Trials at LEO Pharma

Other Identifiers

EBC 9802 INT

Identifier Type: -

Identifier Source: org_study_id