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Traditional (Traditional Chemoembolization) TACE Versus Microsphere TACE

NCT00936689 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2012-12-24

No results posted yet for this study

Summary

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.

Conditions

  • Carcinoma, Hepatocellular

Interventions

PROCEDURE

Selective TACE via microsphere loaded with Doxorubicin

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).

PROCEDURE

Selective traditional TACE

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

Sponsors & Collaborators

  • Rita Golfieri

    lead OTHER

Principal Investigators

  • Rita Golfieri, MD · Azienda Ospedaliero-Universitaria, Policlinico S.Orsola-Malpighi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-12-31
Completion
2012-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00936689 on ClinicalTrials.gov