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Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT00051545
Recruitment Status : Terminated
First Posted : January 14, 2003
Last Update Posted : February 22, 2007
Sponsor:
Information provided by:
LEO Pharma

Study Description
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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
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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
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Outcome Measures
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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
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051545


Locations
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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
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Study Director: Hanne Hvidberg, MScPharm PhD LEO Pharma
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00051545    
Other Study ID Numbers: EBC 9802 INT
First Posted: January 14, 2003    Key Record Dates
Last Update Posted: February 22, 2007
Last Verified: April 2005
Keywords provided by LEO Pharma:
liver
cancer
hepatocellular
carcinoma
Additional relevant MeSH terms:
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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
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs