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Computed Tomography (CT) - Guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma

NCT00807300 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2015-12-03

No results posted yet for this study

Summary

Percutaneous, image-guided tumor ablation has evolved as a genuine alternative for the treatment of unresectable hepatocellular carcinoma. Published data exploring stereotactic or proton beam percutaneous irradiation have revealed,that hepatocellular carcinoma (HCC) is radiosensitive to certain protocols. In Phase I and II studies, the investigators investigated the potential role of local irradiation in primary and secondary liver tumors employing a Iridium192 source. The promising results of previous studies indicate that CT-guided brachytherapy might play a role in the treatment of unresectable HCC.

Therefore, the investigators started a randomized, controlled, clinical Phase-II study to evaluate the efficacy and survival-benefits of brachytherapy versus transarterial chemoembolization in patients with unresectable HCC.

Conditions

Interventions

RADIATION

CT-guided brachytherapy

catheter placed into the tumor by CT-guidance, radiation with iridium 192

PROCEDURE

transarterial chemoembolization

application of doxorubicin and cisplatin in lipiodol into the tumor-feeding artery

Sponsors & Collaborators

  • University of Magdeburg

    lead OTHER

Principal Investigators

  • Jens Ricke, M.D. · Clinic of Diagnostic Radiology and Nuclear Medicine, University Magdeburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases

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 NCT00807300 on ClinicalTrials.gov