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

NCT ID: NCT01686880

Last Updated: 2015-07-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-01-31

Brief Summary

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

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

Conditions

Hepatocellular Carcinoma; Liver Cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Preoperative aTARE

The patients in this arm will receive Sirsphere trans-arterial radioembolization before surgery

Group Type: EXPERIMENTAL

Sirsphere trans-arterial radioembolization

Intervention Type: DEVICE

Patients will receive Sirsphere trans-arterial radioembolization before surgery

Interventions

Sirsphere trans-arterial radioembolization

Patients will receive Sirsphere trans-arterial radioembolization before surgery

Intervention Type: DEVICE

Other Intervention Names

TARE; SIRT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jules Bordet Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alain Hendlisz, MD

Role: PRINCIPAL_INVESTIGATOR

Jules Bordet Institute

Vincent Donckier, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Erasme University Hospital

Locations

Institut Jules Bordet

Brussels, , Belgium

Erasme Hosptial

Brussels, , Belgium

Countries

Belgium

References

Lemaire M, Lucidi V, Bouazza F, Katsanos G, Vanderlinden B, Levillain H, Delatte P, Garcia CA, Vouche M, Galdon MG, Demetter P, Deleporte A, Hendlisz A, Flamen P, Donckier V. Selective internal radiation therapy (SIRT) before partial hepatectomy or radiofrequency destruction for treatment of hepatocellular carcinoma in cirrhotic patients: a feasibility and safety pilot study. HPB (Oxford). 2018 Jul;20(7):641-648. doi: 10.1016/j.hpb.2018.01.006. Epub 2018 Feb 24.

Reference Type: DERIVED

PMID: 29486918 (View on PubMed)

Related Links

http://www.bordet.be/

Jules Bordet Institute

http://www.erasme.ulb.ac.be/

Erasme Hospital

Other Identifiers

TRYPHON

Identifier Type: -

Identifier Source: org_study_id