Y90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver (TRYPHON)

This study is currently recruiting participants.
Verified November 2013 by Jules Bordet Institute
Sponsor:
Information provided by (Responsible Party):
Jules Bordet Institute
ClinicalTrials.gov Identifier:
NCT01686880
First received: September 11, 2012
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to assess the safety of transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with hepatocellular carcinoma


Condition Intervention Phase
Hepatocellular Carcinoma
Liver Cirrhosis
Device: Sirsphere trans-arterial radioembolization
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment With Yttrium90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver

Resource links provided by NLM:


Further study details as provided by Jules Bordet Institute:

Primary Outcome Measures:
  • Peri-operative morbidity [ Time Frame: 3 months after surgery ] [ Designated as safety issue: Yes ]
    peri-operative morbidity of supraselective ablative transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with HCC (starting from date of inclusion till 90 days after surgery or hospital discharge if more than 90 days)


Secondary Outcome Measures:
  • Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Assessment of the overall disease free survival and Overall Survival

  • One and three years survival [ Time Frame: one and three years ] [ Designated as safety issue: No ]
    Estimation of disease free survival and overall survival rates after 1 and 3 years

  • Tumor regression [ Time Frame: 8 weeks after Trans-arterial radioembolization ] [ Designated as safety issue: No ]
    Assessment of tumour size regression after Trans-arterial radioembolization by MRI

  • Functional Imaging [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Assessment of imaging parameters changes (DW-MRI, FDG-PET/CT) and MAA-SPECT-CT in relation to the outcome measured by tumour regression after TARE, disease free and overall survival.

  • Contra-lateral Lobe Hypertrophy [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
    Assessment of TARE induced liver contralateral lobe hypertrophy (volumetric measurement by MRI).


Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preoperative aTARE
The patients in this arm will receive Sirsphere trans-arterial radioembolization before surgery
Device: Sirsphere trans-arterial radioembolization
Patients will receive Sirsphere trans-arterial radioembolization before surgery
Other Names:
  • TARE
  • SIRT

Detailed Description:

The purpose of this study is to assess the peri-operative morbidity and mortality of supraselective ablative transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with HCC

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years.
  • Cirrhotic liver demonstrated by typical liver dysmorphy on imaging and/or liver biopsy.
  • HCC with at least one lesion measuring more than 1 cm in diameter with a single dynamic imaging technique (CT or MRI), showing intense arterial uptake followed by washout of contrast in the venous-delayed phases, or diagnosed by biopsy.
  • Borderline resectable disease eligible for surgical resection or radiofrequency destruction.
  • No extra-hepatic dissemination.
  • ECOG Performance status < 2.
  • Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Signed written informed consent (approved by an Independent Ethics Committee) obtained prior to any study specific baseline procedures.

Exclusion Criteria:

  • Decompensated cirrhosis (Child Pugh B, C).
  • Extra-hepatic tumour spread.
  • Previous or concomitant malignancies within five years other than basal cell carcinoma of the skin.
  • Pregnancy, lactation or refusal to use adequate contraceptive measures (hormonal or barrier method of birth control, abstinence).
  • Pre-existing other hepatic disease (liver abscess, hepatic sarcoidosis or tuberculosis, sclerosing cholangitis, …).
  • Previous trans-arterial radioembolization (TARE).
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition of the administered materials.
  • Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months.
  • Major surgery within four weeks.
  • Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Uncontrolled Diabetes.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686880

Contacts
Contact: Alain Hendlisz, MD +32 0 2 541 35 41 alain.hendlisz@bordet.be
Contact: Vincent Donckier, MD, PhD +32 2 541 72 92 vincent.donckier@erasme.ulb.ac.be

Locations
Belgium
Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Principal Investigator: Alain Hendlisz, MD         
Sub-Investigator: Amélie Deleporte, MD         
Sub-Investigator: Patrick Flamen, MD, PhD         
Sub-Investigator: Philippe Delatte, MD         
Sub-Investigator: Hazem El Mansy, MD         
Erasme Hosptial Recruiting
Brussels, Belgium, 1070
Principal Investigator: Vincent Donckier, MD, PhD         
Sub-Investigator: Valerio Lucidi, MD         
Sub-Investigator: Jean-Luc Van Laethem, MD, PhD         
Sub-Investigator: Maria Antonietta Bali, MD, PhD         
Sub-Investigator: Christophe Moreno, MD, PhD         
Sub-Investigator: Denis Brisbois, MD         
Sub-Investigator: Delphine Degre, MD         
Sub-Investigator: Pieter Demetter, MD, PhD         
Sponsors and Collaborators
Jules Bordet Institute
Investigators
Principal Investigator: Alain Hendlisz, MD Institut Jules Bordet
Principal Investigator: Vincent Donckier, MD, PHD Erasme University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT01686880     History of Changes
Other Study ID Numbers: TRYPHON
Study First Received: September 11, 2012
Last Updated: November 20, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by Jules Bordet Institute:
Hepatocellular Carcinoma
Liver Cirrhosis
radioembolization
SIRT
TARE
Sirspheres
neoadjuvant
liver cancer

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

ClinicalTrials.gov processed this record on April 21, 2014