The overall goal of this RCT is to compare the efficacy of 90Y-RE to TACE-DEB, for patients with intermediate stage HCC. Time to progression, overall survival, tumor response, adverse events, treatment related effect on total liver function, quality…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: time to progression.
Secondary outcome
Secondary endpoints: overall survival, tumor response, toxicities/adverse
events, treatment related effect on total liver function, quality of life and
treatment-related costs.
Background summary
Transarterial Yttrium-90 radioembolization (90Y-RE) is a novel technique for
locoregional treatment of hepatocellular carcinoma (HCC). Although
transarterial chemoembolization (TACE) is currently the standard of care for
intermediate stage HCC patients, 90Y-RE is also used in the same group of
patients, and it is unclear which treatment has a better efficacy. This
randomized controlled trial (RCT) is designed to compare efficacy of 90Y-RE
with TACE with drug eluting beads (DEB), for patients with intermediate stage
HCC.
Study objective
The overall goal of this RCT is to compare the efficacy of 90Y-RE to TACE-DEB,
for patients with intermediate stage HCC. Time to progression, overall
survival, tumor response, adverse events, treatment related effect on total
liver function, quality of life and treatment-related costs will be compared.
Study design
Multicenter randomised controlled intervention study.
Intervention
The intervention consists of either treatment with TACE-DEB, the standard of
care, or 90Y-RE.
Study burden and risks
Patients with intermediate stage HCC are randomly assigned to either 90Y-RE or
TACE-DEB. Both treatments are already performed in daily clinical practice and
efficacy in large cohorts has been described, with a median survival of 16-20
months. Risks of both treatments are described in the literature and
acceptable. Post procedural MRI is performed to investigate treatment effect
(tumor response) at 1 months after baseline (the date of the first treatment
T0), 3 months after baseline and at 3 monthly intervals thereafter for two
years. This follow-up strategy is also implemented in usual medical practice.
The patient is seen by the treating physician during regular visits to the
outpatient clinic. Regular laboratory examination will be performed during
these visits. Adverse events and toxicities are recorded and monitored for 6
months following last treatment. Patients are asked to fill out questionnaires
for quality of life assessment before and after treatment. Questionnaires will
be sent to the patients* home address by mail.
Postbus 85500
3508 GA Utrecht
NL
Postbus 85500
3508 GA Utrecht
NL
Listed location countries
Age
Inclusion criteria
- Written informed consent
- Diagnosis HCC confirmed by typical appearance on imaging, i.e. hypervascular enhancing lesion in the arterial phase and contrast washout in the portal venous or delayed phase, or by cytohistological tissue sampling by biopsy in case of inconclusive imaging findings
- Intermediate stage HCC as defined by the BCLC criteria, i.e. >3 lesions >3cm in size, or 1 lesion >5cm in size (BCLC stage B )
- absence of extrahepatic disease
- Age >= 18 years
- Child-Pugh A-B7
- ECOG performance status (PST) 0-1
Exclusion criteria
- Inadequate bone marrow function (hemoglobulin <6.0 mmol/l, absolute neutrophil count < 1.5 x 109/l, platelet count <60 x 109/l)
- Inadequate liver function (bilirubin >45 µmol/l (or 2.6 mg/dl), albumin <28 g/l, AST/ALT >5x upper limit of normal (ULN)
- Inadequate renal function (creatinine >1.5x ULN)
- Compromised biliary system
- Hypersensivity to doxorubicin
- Pregnancy or breast feeding
- >50% of liver involvement
- main portal vein (right, left or common trunk) thrombosis
- 99mTc-MAA-scintigraphy shows limited MAA uptake (photopenic lesion)
- Lung shunting fraction >20%
- Patients who are declared incompetent or suffering from psychic disorders that make a
comprehensive judgement impossible, such as psychosis
- Previous local treatment of study target lesion(s)
- Allergy for i.v. contrast used (Visipaque®)
- Life expectancy <3 months or otherwise impossible follow-up
- Patients in whom hepatic artery catheterization is contraindicated; such as patients with vascular abnormalities or bleeding diathesis (indicated by a PT >6 seconds over control)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-001794-85-NL |
| CCMO | NL33784.041.11 |