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A randomized phase II study of doxorubicin combined with thalidomide versus doxorubicin alone for patients with unresectable hepatocellular carcinoma.


- candidate number1707
- NTR NumberNTR411
- ISRCTNISRCTN53872240
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR20-sep-2005
- Secondary IDsEMC 04-046 
- Public TitleA randomized phase II study of doxorubicin combined with thalidomide versus doxorubicin alone for patients with unresectable hepatocellular carcinoma.
- Scientific TitleA randomized phase II study of doxorubicin combined with thalidomide versus doxorubicin alone for patients with unresectable hepatocellular carcinoma.
- ACRONYMHCC
- hypothesisPrevious trials showed that both doxorubicin and thalidomide have anti-tumor activity against hepatocellular carcinoma (HCC). There are indications that these two agents interact synergistically and have non-overlapping toxicity profiles. This trial studies the feasibility and efficacy of doxorubicin combined with thalidomide for the treatment of hepatocellular carcinoma, compared with doxorubicin as single agent.
- Healt Condition(s) or Problem(s) studiedHepatocellular carcinoma
- Inclusion criteriaHistologically proven HCC, irresectable tumor, failure to previous treatment, WHO 0-2, at least 4 weeks since prior treatment with HMG-Coa reductase inhibitors or systemic immunosuppresiva, adequate hepatic and bone marrow function.
- Exclusion criteriaPrior treatment with doxorubicin or thalidomide, uncontrolled hypertension, unstable angina, arrhythmias requiring treatment, MI, thrombo-embolic events requiring treatment, congestive heartfailure or cardiomyopathy requiring treatment, peripheral neuropathy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 17-jun-2004
- planned closingdate1-jan-2008
- Target number of participants30
- InterventionsControl arm: doxorubicin 60 mg/m2 day 1, three weekly course with in total 6 cycles (maximum 360 mg/m2) given intravenously in 15 minutes. Experimental arm: doxorubicin treatment as in control arm plus from day 3 on, thalidomide 200 mg daily administerd in the evening. When doxorubicin administration has finished, thalidomide should be continued until progression of disease.
- Primary outcomeThe 1-year survival.
- Secondary outcomeResponse rate scored according to RECIST criteria, time to progression, quality of life, and toxicity.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. S. Sleijfer
- CONTACT for SCIENTIFIC QUERIESDr. S. Sleijfer
- Sponsor/Initiator Erasmus Medical Center, Department of Medical Oncology
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD20-sep-2005 - 7-mrt-2006


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