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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 : August 8, 2018
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Health Holland
Quirem Medical B.V.
Medtronic
Maag Darm Lever stichting
Information provided by (Responsible Party):
MCBurgmans, Leiden University Medical Center

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.

Condition or disease Intervention/treatment Phase
HCC Early Stage HCC Device: Quirem Medical Holmium-166 radioembolization microspheres Not Applicable

Detailed Description:
RFA + adjuvant radioembolsation with Quirem Spheres

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: single-arm, interventional, dose escalation study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HOlmium Radioembolization as Adjuvant Treatment to Radiofrequency Ablation for Early STage Hepatocellular Carcinoma (HORA EST HCC)
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Holmium

Arm Intervention/treatment
RFA + radioembolization
Quirem Medical Holmium-166 radioembolization microspheres
Device: Quirem Medical Holmium-166 radioembolization microspheres
radioembolisation as adjuvant treatment to RFA




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 1 year ]
    Toxicity of RFA with adjuvant segmental radioembolization as assessed by complications according to CTCAE v4.0

  2. Local tumor recurrence [ Time Frame: 6 months and 12 months ]
    Local tumor recurrence at 6 months as assessed by multiphase CT or dynamic MRI

  3. Time to progression [ Time Frame: 1 year ]
    time until disease progresses

  4. Progression-free survival [ Time Frame: 1 year ]
    Kaplan-Meier analysis of progression free survival

  5. 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

  6. Quality of Life [ Time Frame: Throughout the first year after treatment. ]
    Quality of Life will be assessed by means of the C-30 questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437382


Contacts
Contact: Mark Burgmans, MD, PhD +31-71 5262410 m.c.burgmans@lumc.nl
Contact: Pim Hendriks, MSc. +31-71 5298161 p.hendriks@lumc.nl

Locations
Netherlands
Leiden University Medical Center Recruiting
Leiden, Zuid-Holland, Netherlands, 2333ZA
Contact: Mark Burgmans, MD, PhD    +31-71 5262410    m.c.burgmans@lumc.nl   
Contact: Pim Hendriks, MSc.    +31-71 5298161    p.hendriks@lumc.nl   
Sponsors and Collaborators
Leiden University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Health Holland
Quirem Medical B.V.
Medtronic
Maag Darm Lever stichting

Responsible Party: MCBurgmans, Principle Investigator, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT03437382     History of Changes
Other Study ID Numbers: P17.161
ZonMW ( Other Grant/Funding Number: PTO 2017 - 40-41200-98-9286 )
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by MCBurgmans, Leiden University Medical Center:
Hepatocellular carcinoma
Radiofrequency ablation (RFA)
Radioembolization
Quirem Spheres
Selective internal radiation therapy

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases