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Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma
This study has been terminated.
Study NCT00051545   Information provided by LEO Pharma
First Received: January 13, 2003   Last Updated: February 21, 2007   History of Changes

January 13, 2003
February 21, 2007
November 1999
 
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
 
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).

 
Phase III
Interventional
Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Liver Neoplasms
Drug: Seocalcitol
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
608
June 2004
 

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
LEO Pharma
 
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