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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

Tracking Information
First Submitted Date  ICMJE January 13, 2003
First Posted Date  ICMJE January 14, 2003
Last Update Posted Date February 22, 2007
Study Start Date  ICMJE November 1999
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)		 Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Educational/Counseling/Training
Condition  ICMJE Liver Neoplasms
Intervention  ICMJE Drug: Seocalcitol
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: June 23, 2005)		 608
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Italy,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00051545
Other Study ID Numbers  ICMJE EBC 9802 INT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE LEO Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hanne Hvidberg, MScPharm PhD LEO Pharma
PRS Account LEO Pharma
Verification Date April 2005

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