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

Hepatocellular Carcinoma Clinical Trial

— TRYPHON  

Official title:

Treatment With Yttrium90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01686880
• Other study ID #: TRYPHON
• Status: Terminated
• Phase: Phase 2
• First received: September 11, 2012
• Last updated: June 30, 2015
• Start date: September 2012
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: Jules Bordet Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Cirrhosis

Intervention

Device:
• Sirsphere trans-arterial radioembolization
Patients will receive Sirsphere trans-arterial radioembolization before surgery

Locations

Country	Name	City	State
Belgium	Erasme Hosptial	Brussels
Belgium	Institut Jules Bordet	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Jules Bordet Institute

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peri-operative morbidity	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)	3 months after surgery	Yes
Secondary	Survival	Assessment of the overall disease free survival and Overall Survival	3 years	No
Secondary	One and three years survival	Estimation of disease free survival and overall survival rates after 1 and 3 years	one and three years	No
Secondary	Tumor regression	Assessment of tumour size regression after Trans-arterial radioembolization by MRI	8 weeks after Trans-arterial radioembolization	No
Secondary	Functional Imaging	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.	3 years	No
Secondary	Contra-lateral Lobe Hypertrophy	Assessment of TARE induced liver contralateral lobe hypertrophy (volumetric measurement by MRI).	3 Years	No

External Links

•   Erasme Hospital
•   Jules Bordet Institute