Clinical trial NCT00051545: Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Liver Neoplasms
Keywords: liver
cancer
hepatocellular
carcinoma
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2003-01-14
Enrollment: 608
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


Eligibility 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.

Primary outcomes:
measure: Time to relapse, relapse being defined as the first recurrence of HCC (intra- or extrahepatic).
Secondary outcomes:
measure: Survival
measure: Time to distant recurrence of HCC
measure: Time to second primary HCC
measure: Time to development of metastases
measure: Tumour measurements
measure: Tumour marker (alpha-fetoprotein AFP)
measure: Quality of life
measure: Length of hospital stay
measure: Adverse events
measure: Laboratory safety examinations
measure: Dose of Seocalcitol
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: E.g., University Health Network Toronto General Hospital (numerous facilities in Canada are recruiting)
state: Ontario
city: Metz
country: France
facility: E.g., Hopital Notre-Dame de Bon Secour, Service de Hepato-gastro-enterologie (numerous facilities are recruiting in France)
city: Milano
country: Italy
facility: E.g., Osp. Maggiore, Policlinico di Milano, Divisione di Medicina Interna (numerous facilities are recruiting in Italy)
city: Barcelona
country: Spain
facility: E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain)
city: Edinburgh
country: United Kingdom
facility: E.g., The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK)
Study officials:
affiliation: LEO Pharma
name: Hanne Hvidberg, MScPharm PhD
role: STUDY_DIRECTOR
References: