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

NCT00807300 | Completed Phase 2

• 1 other identifier: 2005-000569-21
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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

Hepatocellular Carcinoma

Keywords

percutaneous treatment

Outcome Measures

Primary Outcomes (1)

• Time to untreatable progression

  the follow up period

Secondary Outcomes (2)

• Time to progression

  the follow up period

• Overall survival

  the follow up period

Study Arms (2)

brachytherapy

ACTIVE COMPARATOR

Radiation: CT-guided brachytherapy

TACE

OTHER

transarterial chemoembolization

Procedure: transarterial chemoembolization

Interventions

CT-guided brachytherapy RADIATION

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

brachytherapy

transarterial chemoembolization PROCEDURE

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

TACE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Magdeburg: lead

Study Sites (1)

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

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jens Ricke, M.D.

  Clinic of Diagnostic Radiology and Nuclear Medicine, University Magdeburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Jens Ricke

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 11, 2008
• Study Start: October 1, 2006
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

DE (1)