Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma

Liver Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00051545
• Other study ID #: EBC 9802 INT
• Status: Terminated
• Phase: Phase 3
• First received: January 13, 2003
• Last updated: February 21, 2007
• Start date: November 1999
• Est. completion date: June 2004

Study information

• Verified date: April 2005
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 608
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Neoplasms

Intervention

Drug:
• Seocalcitol

Locations

Country	Name	City	State
Canada	E.g., University Health Network Toronto General Hospital (numerous facilities in Canada are recruiting)	Toronto	Ontario
France	E.g., Hopital Notre-Dame de Bon Secour, Service de Hepato-gastro-enterologie (numerous facilities are recruiting in France)	Metz
Italy	E.g., Osp. Maggiore, Policlinico di Milano, Divisione di Medicina Interna (numerous facilities are recruiting in Italy)	Milano
Spain	E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain)	Barcelona
United Kingdom	E.g., The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK)	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

Canada,  France,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic).
Secondary	Survival
Secondary	Time to distant recurrence of HCC
Secondary	Time to second primary HCC
Secondary	Time to development of metastases
Secondary	Tumour measurements
Secondary	Tumour marker (alpha-fetoprotein AFP)
Secondary	Quality of life
Secondary	Length of hospital stay
Secondary	Adverse events
Secondary	Laboratory safety examinations
Secondary	Dose of Seocalcitol

External Links

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