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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
CT-guided brachytherapy
transarterial chemoembolization
Sponsored by
University of Magdeburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring percutaneous treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

brachytherapy

TACE

Arm Description

transarterial chemoembolization

Outcomes

Primary Outcome Measures

Time to untreatable progression

Secondary Outcome Measures

Time to progression
Overall survival

Full Information

First Posted
December 9, 2008
Last Updated
December 2, 2015
Sponsor
University of Magdeburg
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1. Study Identification

Unique Protocol Identification Number
NCT00807300
Brief Title
Computed Tomography (CT) - Guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma
Acronym
CEAL
Official Title
Phase-III-Study to Evaluate the Efficacy of CT-guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Magdeburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
percutaneous treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
brachytherapy
Arm Type
Active Comparator
Arm Title
TACE
Arm Type
Other
Arm Description
transarterial chemoembolization
Intervention Type
Radiation
Intervention Name(s)
CT-guided brachytherapy
Intervention Description
catheter placed into the tumor by CT-guidance, radiation with iridium 192
Intervention Type
Procedure
Intervention Name(s)
transarterial chemoembolization
Intervention Description
application of doxorubicin and cisplatin in lipiodol into the tumor-feeding artery
Primary Outcome Measure Information:
Title
Time to untreatable progression
Time Frame
the follow up period
Secondary Outcome Measure Information:
Title
Time to progression
Time Frame
the follow up period
Title
Overall survival
Time Frame
the follow up period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Ricke, M.D.
Organizational Affiliation
Clinic of Diagnostic Radiology and Nuclear Medicine, University Magdeburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic of Diagnostic Radiology and Nuclear Medicine, Medical Faculty, University Magdeburg
City
Magdeburg
State/Province
Saxony-anhalt
ZIP/Postal Code
39120
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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