MedDataX Logo

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

NCT ID: NCT00807300

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

brachytherapy

Group Type ACTIVE_COMPARATOR

CT-guided brachytherapy

Intervention Type RADIATION

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

TACE

transarterial chemoembolization

Group Type OTHER

transarterial chemoembolization

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CT-guided brachytherapy

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

Intervention Type RADIATION

transarterial chemoembolization

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* diagnosis of HCC by histopathology or according to the criteria of the Consensus Conference of the European Association for the Study of Liver Disease
* unresectable HCC
* Karnofsky-Index \> 70
* estimated life expectancy \> 16 weeks
* adequate bone marrow function
* adequate contraception for female patients
* informed consent

Exclusion Criteria

* portal vein thrombosis on the tumor side
* extrahepatic spread
* Child C
* other untreated malignant disease
* general contraindication for chemotherapy
* active infectious disease
* neuropathy, platin-allergy
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Magdeburg

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jens Ricke

Prof. Jens Ricke

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jens Ricke, M.D.

Role: PRINCIPAL_INVESTIGATOR

Clinic of Diagnostic Radiology and Nuclear Medicine, University Magdeburg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinic of Diagnostic Radiology and Nuclear Medicine, Medical Faculty, University Magdeburg

Magdeburg, Saxony-Anhalt, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2005-000569-21

Identifier Type: -

Identifier Source: org_study_id