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Home > "S" Clinical Trials Conditions > Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma.  Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma.
Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma.
For Condition: Liver Neoplasms
Status: Recruiting
Sponsor(s): LEO Pharma ,
Synopsis: 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.
Details: -
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Expanded Access Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 608
Location and Contact Information:
Overall Study Official:
HelleGullestrup, Study Director, LEO Pharma
E.g., Hopital Beaujon, Department Hepato-gastro-enterologie 2 (numerous facilities are recruiting in France) *Recruiting*
Clichy, , F-92110
France
Recruiting Francoise Degos +33 1 40 87 55 27
E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain) *Recruiting*
Barcelona, , E-08036
Spain
Recruiting Jordi Bruix +34 93 227 5400
E.g., University Health Network Toronto General Hospital (numerous facilities in Canada are recruiting) *Recruiting*
Toronto, Ontario, M5G2C4
Canada
Recruiting Morris Sherman 416 3404 756
E.g., Azienda Ospedaliera di Padova, Divisione di Gastroenterologia (numerous facilities are recruiting in Italy) *Recruiting*
Padova, , I-35 128
Italy
Recruiting Fabio Farinati +39 49 82 12 89 24
E.g., Western General Infirmary NHS Trust (numerous facilities are recruiting in UK) *Recruiting*
Glasgow, , G11 6NT
United Kingdom
Recruiting T Evans +44 141 211 1741
Additional Information:
Study ID Numbers: EBC 9802 INT;
Study Start Date: November 1999
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00051545
Other Liver Neoplasms Studies:
1. Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma
2. Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver
3. Photodynamic therapy with talaporfin sodium (LS11) in treating patients with refractory colorectal liver metastases
4. Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma.
5. A Phase I Study of Isolated Hepatic Portal and Arterial Perfusion (IHP) with Escalating Dose Melphalan for Primary or Metastatic Unresectable Cancers of the Liver
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Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma.
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