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Chemoembolization by standard technique: epirubicin (maximum dose of 75 mg) conjugated with an oil-based contrast medium (Lipiodol) at the maximum dose of 15 ml + gelatin sponge particles(particles of transient embolization material, required to obstruct the treated vessel).

Chemoembolization with microspheres: doxorubicin (maximum dose of 75 mg x vials of microspheres) loaded with non-reabsorbable microspheres (sulfate hydrospheres) at the dose of 2 ml per vial (definitive embolization).

Selective TACE via microsphere loaded with Doxorubicin

Traditional chemoembolization: epirubicin (maximum dose of 75 mg) conjugated with Lipiodol at the maximum dose of 15 ml + Spongel.

Selective traditional TACE

Rita Golfieri, MD

Background

Hepatic intra-arterial chemoembolization (TACE) is proposed when potentially curative therapy (eg. surgical resection, percutaneous ablation)is no longer possible. Prospective and non-randomized retrospective studies showed TACE to be capable to increase survival vs controls. In 2002 the first results of two RCTs were published which had been conducted on unresectable HCC patients, designed to assess the impact produced by TACE on survival, demonstrated a statistically significant advantage in TACE treated patients compared to controls. The same results have been confirmed by a meta-analysis conducted on 14 trials published in literature. The limitations of TACE are represented however by the difficulties in obtaining a complete necrosis of the lesion treated and for this reason new embolization agents are being developed to increase the efficacy of TACE in HCC as the microsphere, in poly vinyl alcohol and co-acrylic acid that are not reabsorbable and induce permanent embolization. The first experimental studies using microsphere showed the good tolerability and the higher rate of tumor necrosis, but no RCTs have been conducted to investigate their impact on survival. Objectives. The primary aim of this study is to compare 2 years survival of patients randomized to selective traditional TACE or selective TACE via microspheres loaded with Doxorubicin. Secondary objectives investigate the time to progression of disease (radiologic and symptomatic) by radiologic, laboratory tests and the QoL questionnaire administration. Methods. This is a multicentre, randomized, open-label, active controlled study in HCC patients treated with standard TACE vs TACE with doxorubicin - loaded microsphere. The study comprises a selection period, a treatment period and a follow up phase with a total duration of 2 years from randomization. Expected results. The sample size(alfa 5%, power 80%) is adequate to detect a 20% difference between TACE with microsphere vs traditional TACE.

Traditional (Traditional Chemoembolization) TACE Versus Microsphere TACE

Treatment of Hepatocellular Carcinoma (HCC)by Selective Traditional Chemoembolization(TACE)Versus Selective TACE Via Microspheres Loaded With Doxorubicin: a Multicentre,Randomized,Open Label,Controlled Study.

Rita Golfieri

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Traditional (Traditional Chemoembolization) TACE Versus Microsphere TACE	NCT00936689	Carcinoma, Hepa...	Selective TACE ... Selective tradi...	18 Years -	University of Bologna
Traditional (Traditional Chemoembolization) TACE Versus Microsphere TACE	NCT00936689	Carcinoma, Hepa...	Selective TACE ... Selective tradi...	18 Years -	University of Bologna

Spots Global Cancer Trial Database for selective traditional tace