HOlmium radioembolization as adjuvant treatment to Radiofrequency Ablation for Early STage Hepatocellular carcinoma (HORA EST HCC): a dose-finding study

Completed

• Conditions: hepatocellular carcinoma; Liver cancer; 10019815

• Registration Number: NL-OMON50687
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-03-15
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

* Informed consent
* Age > 18 years
* Single HCC lesion with diameter of * 2-5cm or up to three lesions with each
lesion measuring no more than 3cm (confined to one liver lobe)
* HCC diagnosis is based on histology or non-invasive imaging criteria
according to EORTC-EASL guidelines
* Child Pugh A or B * 7
* ECOG performance status * 2
* Bilirubin < 2mg/dL
* ASAT < 5x upper limit of normal
* ALAT < 5x upper limit of normal
* Thrombocytes * 50 X 10^9/L

Exclusion Criteria

* Tumor location precluding percutaneous RFA
* Treatment area >50% of total liver volume, based on CBCT images
* Vascular tumor invasion or extrahepatic metastasis
* Main portal vein thrombosis
* Hemihepatectomy
* Severe comorbidity (e.g. cardiovascular disease, diabetes with nephropathy,
active infections)
* Uncorrectable coagulopathy
* Large arterio-portovenous shunt
* Previous radiotherapy to the liver
* Surgical hepatico-enterostomy
* Hepatic resection with placement of surgical clips that may cause artefacts
on MRI
* Incompetent / mentally disabled
* Pregnancy, inadequate anticonception
* Calculated lung dose >30Gy
* Creatinine clearance < 30 ml/min

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Establishment of treatment area dose at which 90% technical success is<br /><br>achieved. Technical success will be defined as * 120Gy calculated radiation<br /><br>absorbed dose to the target area, i.e. the hyperaemic zone surrounding the area<br /><br>of post-RFA coagulation necrosis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Toxicity of RFA with adjuvant segmental radioembolization as assessed by<br /><br>complications according to CTCAE v4.0<br /><br>* Local tumor recurrence at 6 months as assessed by multiphase CT or dynamic MRI<br /><br>* Local tumor recurrence rate at 12 months as assessed by multiphase CT or<br /><br>dynamic MRI<br /><br>* Time-to-progression<br /><br>* Progression free-survival and overall survival at 1 year<br /><br>* Quality of Life</p><br>