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NCT Number: NCT00807300

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Magdeburg, Saxony-Anhalt, 39120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT-guided brachytherapy

Radiation

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

Transarterial chemoembolization

Procedure

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

Primary outcomes

  1. Time to untreatable progression

    Time frame: the follow up period

Secondary outcomes

  1. Time to progression

    Time frame: the follow up period

  2. Overall survival

    Time frame: the follow up period

Sponsors and collaborators

Lead sponsor

University of Magdeburg

Other

Registry information

Official study title

Phase-III-Study to Evaluate the Efficacy of CT-guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma.

Acronym: CEAL

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Dec 11, 2008
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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