Status:
COMPLETED
Radioembolization With Yttrium-90 Microspheres for Intermediate or Advanced Hepatocellular Carcinoma
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborating Sponsors:
Gastro Intestinal Surgery and Liver Transplantation
The Hepato-Oncology Group: Department of Surgery, Medicine and Radiology
Conditions:
Hepatocellular Carcinoma
Liver Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Rationale: Patients diagnosed with hepatocellular carcinoma (HCC) at an intermediate or advanced stage (according to the BCLC classification system) are not amenable of curative treatment. According t...
Detailed Description
Patients at an intermediate stage (BCLC-B) are currently offered trans-arterial chemoembolisation (TACE) as the standard of care. A recent meta-analysis showed that radioembolization with beta-emittin...
Eligibility Criteria
Inclusion
- Diagnosis of HCC confirmed by histology or non-invasive criteria (EASL/AASLD)
- Intermediate stage (BCLC-B) HCC: patients with a large or multinodular HCC (single HCC \> 5 cm or multiple HCC defined as \> 3 nodules \> 3 cm), a Child Pugh class A or B7 and no cancer related symptoms (PS=0-1).
- Advanced stage (BCLC-C) HCC: patients with hepatic vascular involvement (at any tumor number and diameter), a Child Pugh class A or B7, no cancer related symptoms (PS=0-1) and absence of extra-hepatic tumor spread.
- Cancer-related symptoms within the ECOG 0-1 score
- Liver function within Child B-7 class
- Platelets \> 50.000/µL
- WBC \> 1500/µL
- AST/ALT \< 5 times the upper limit of normal (U/L)
- Creatinine \< 2.0 mg /dL
- No indication for any possible curative treatment after multidisciplinary assessment (resection, ablation, transplantation)
- Signed informed consent
Exclusion
- Child-Pugh class higher than B-7 at entry
- ECOG performance score ≥ 2 at entry
- Tumor volume ≥ 50% of liver volume
- Extrahepatic tumor spread
- Pulmonary insufficiency
- Life expectancy of less than 3 months due to HCC or less than 6 months due to any other disease
- Previous chemoembolization procedure (TACE)
- Evidence on 99mTc-MAA scan of vascular shunts that can not be corrected by angiographic coil embolization
- Evidence on 99mTc-MAA scan of lung shunting, with a potential absorbed dose of radiation to the lungs \> 30 Gy
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00910572
Start Date
July 1 2007
End Date
May 1 2010
Last Update
July 1 2011
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Milan, Italy, 20133