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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


Phase 3
18 Years
75 Years
Not Enrolling
Both
Liver Neoplasms

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Outcome Measure:

Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic).

Principal Investigator

Hanne Hvidberg, MScPharm PhD

Investigator Role:

Study Director

Investigator Affiliation:

LEO Pharma

Authority:

United States: Food and Drug Administration

Study ID:

EBC 9802 INT

NCT ID:

NCT00051545

Start Date:

November 1999

Completion Date:

June 2004

Related Keywords:

  • Liver Neoplasms
  • liver
  • cancer
  • hepatocellular
  • carcinoma
  • Neoplasms
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

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