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Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma

Primary Purpose

Liver Neoplasms

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Seocalcitol
Sponsored by
LEO Pharma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Liver Neoplasms focused on measuring liver, cancer, hepatocellular, carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Outcomes

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

Full Information

First Posted
January 13, 2003
Last Updated
February 21, 2007
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00051545
Brief Title
Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma
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 Type
Interventional

2. Study Status

Record Verification Date
April 2005
Overall Recruitment Status
Terminated
Study Start Date
November 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
LEO Pharma

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Neoplasms
Keywords
liver, cancer, hepatocellular, carcinoma

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
608 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Seocalcitol
Primary Outcome Measure Information:
Title
Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic).
Secondary Outcome Measure Information:
Title
Survival
Title
Time to distant recurrence of HCC
Title
Time to second primary HCC
Title
Time to development of metastases
Title
Tumour measurements
Title
Tumour marker (alpha-fetoprotein AFP)
Title
Quality of life
Title
Length of hospital stay
Title
Adverse events
Title
Laboratory safety examinations
Title
Dose of Seocalcitol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanne Hvidberg, MScPharm PhD
Organizational Affiliation
LEO Pharma
Official's Role
Study Director
Facility Information:
Facility Name
E.g., University Health Network Toronto General Hospital (numerous facilities in Canada are recruiting)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2C4
Country
Canada
Facility Name
E.g., Hopital Notre-Dame de Bon Secour, Service de Hepato-gastro-enterologie (numerous facilities are recruiting in France)
City
Metz
ZIP/Postal Code
F-57038 Metz Cedex
Country
France
Facility Name
E.g., Osp. Maggiore, Policlinico di Milano, Divisione di Medicina Interna (numerous facilities are recruiting in Italy)
City
Milano
ZIP/Postal Code
I-20 122
Country
Italy
Facility Name
E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain)
City
Barcelona
ZIP/Postal Code
E-08036
Country
Spain
Facility Name
E.g., The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK)
City
Edinburgh
ZIP/Postal Code
EH3 9YW
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.leo-pharma.com
Description
Click here for more information about this study: Drug Development, Pipeline, Seocalcitol

Learn more about this trial

Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma

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