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Holmium Radioembolization as Adjuvant Treatment to RFA for Early Stage HCC: Dose Finding Study (HORA EST HCC)

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ClinicalTrials.gov Identifier: NCT03437382
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : October 1, 2019
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Health Holland
Quirem Medical B.V.
Medtronic
Maag Lever Darm Stichting
Information provided by (Responsible Party):
MCBurgmans, Leiden University Medical Center

Tracking Information
First Submitted Date  ICMJE January 31, 2018
First Posted Date  ICMJE February 19, 2018
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2018)
Dose-finding [ Time Frame: 1 year ]
Treatment area dose that will result in delivery of a radiation absorbed dose of ≥ 120Gy to the target area in at least 90% of patients.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2018)
  • Toxicity [ Time Frame: 1 year ]
    Toxicity of RFA with adjuvant segmental radioembolization as assessed by complications according to CTCAE v4.0
  • Local tumor recurrence [ Time Frame: 6 months and 12 months ]
    Local tumor recurrence at 6 months as assessed by multiphase CT or dynamic MRI
  • Time to progression [ Time Frame: 1 year ]
    time until disease progresses
  • Progression-free survival [ Time Frame: 1 year ]
    Kaplan-Meier analysis of progression free survival
  • Quality of Life [ Time Frame: Throughout the first year after treatment. ]
    Quality of Life will be assessed by means of the EORTC QLQ HCC-18 questionnaire
  • Quality of Life [ Time Frame: Throughout the first year after treatment. ]
    Quality of Life will be assessed by means of the C-30 questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Holmium Radioembolization as Adjuvant Treatment to RFA for Early Stage HCC: Dose Finding Study
Official Title  ICMJE HOlmium Radioembolization as Adjuvant Treatment to Radiofrequency Ablation for Early STage Hepatocellular Carcinoma (HORA EST HCC)
Brief Summary In this multi-center, dose-finding study, patients with early stage hepatocellular carcinoma according to the Barcelona Clinic Liver Cancer (BCLC) staging system will be included to receive percutaneous radiofrequency ablation in combination with RFA with adjuvant segmental radioembolization.
Detailed Description RFA + adjuvant radioembolsation with Quirem Spheres
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
single-arm, interventional, dose escalation study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HCC
  • Early Stage HCC
Intervention  ICMJE Device: Quirem Medical Holmium-166 radioembolization microspheres
radioembolisation as adjuvant treatment to RFA
Study Arms  ICMJE RFA + radioembolization
Quirem Medical Holmium-166 radioembolization microspheres
Intervention: Device: Quirem Medical Holmium-166 radioembolization microspheres
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 12, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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:

  • Recurrent HCC
  • Tumor location precluding percutaneous RFA
  • Bilobar tumor involvement
  • Vascular tumor invasion or extrahepatic metastasis
  • 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 < 50 ml/min
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mark Burgmans, MD, PhD +31-71 5262410 m.c.burgmans@lumc.nl
Contact: Pim Hendriks, MSc. +31-71 5298161 p.hendriks@lumc.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03437382
Other Study ID Numbers  ICMJE P17.161
ZonMW ( Other Grant/Funding Number: PTO 2017 - 40-41200-98-9286 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party MCBurgmans, Leiden University Medical Center
Study Sponsor  ICMJE Leiden University Medical Center
Collaborators  ICMJE
  • ZonMw: The Netherlands Organisation for Health Research and Development
  • Health Holland
  • Quirem Medical B.V.
  • Medtronic
  • Maag Lever Darm Stichting
Investigators  ICMJE Not Provided
PRS Account Leiden University Medical Center
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP