Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma

This study has been terminated.
Sponsor:
Information provided by:
LEO Pharma
ClinicalTrials.gov Identifier:
NCT00051545
First received: January 13, 2003
Last updated: February 21, 2007
Last verified: April 2005

January 13, 2003
February 21, 2007
November 1999
Not Provided
Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic).
Same as current
Complete list of historical versions of study NCT00051545 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma
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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
Liver Neoplasms
Drug: Seocalcitol
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
608
June 2004
Not Provided

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   Italy,   Spain,   United Kingdom
 
NCT00051545
EBC 9802 INT
Not Provided
Not Provided
LEO Pharma
Not Provided
Study Director: Hanne Hvidberg, MScPharm PhD LEO Pharma
LEO Pharma
April 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP