The purpose of this study is to determine whether a treatment with Therasphere which is optimized is more efficient compared to a standard treatment for patients suffering from hepatocellular carcinomas.
For patients suffering from hepatocellular carcinoma, a palliative treatment can be proposed if tumor expansion is limited to the liver. One of palliative treatment is the the Selective Internal Radiation Therapy (SIRT) with Therasphere®. This treatment is made secure by performing a diagnostic angiogram coupled with a hepatic perfusion scintigraph with which patients at risk of complications are identified and excluded. The treatment objective, with the standard dosimetric approach, is to deliver an absorbed dose of 120 ± 20 Gy to the treated hepatic volume, most often one lobe. Recent retrospective trials show that an optimized dosimetric approach, considering the dose absorbed by the tumor, is technically achievable and would probably make it possible to obtain a better effectiveness. In our experience, treatment personalisation have been described to be used for 60% of the patients with a tumor larger than 7 cm underlying the clinical impact of this new approach.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Injection of yttrium-90 microspheres (TheraSphere®) is performed during the therapeutic angiogram, directly into the hepatic artery (left or right, or even segmental). Optimized dosimetry arm: the activity to be administered is calculated so as to deliver predictive dosimetry: * An absorbed dose to the tumor of at least ≥ 205 Gy and if possible exceeding 250 Gy or even 300 Gy * A dose at the treated healthy liver \< 120 Gy in case of lobar treatment * Dose to the treated healthy liver can exceed 120 Gy in case of segmental treatment and hepatic reserve \> 30% * A pulmonary dose \< 30 Gy for one treatment and \< 50 Gy in cumulative dose in case of multiple treatments.
Injection of yttrium-90 microspheres (TheraSphere®) is performed during the therapeutic angiogram, directly into the hepatic artery (left or right, or even segmental).Standard dosimetry arm: the activity to be administered is calculated so as predictive dosimetry: * An absorbed dose of 120 ± 20 Gy to the treated volume (whatever the tumor absorbed dose) * A pulmonary dose \< 30 Gy for one treatment and \< 50 Gy in cumulative dose in case of multiple treatments.
CHU Henri Mondor
Créteil, France
CHU Saint Eloi
Montpellier, France
Centre Eugène Marquis
Rennes, France
Gustave Roussy
Villejuif, France
The primary endpoint is to compare the response rate of the treated lesion at the first radioembolization, evaluated using European Association for the Study of the Liver (EASL) criteria of yttrium-90 marked glass microspheres SIRT
Time frame: 3 months after treatment administration
Progression Free Survival
Time frame: Up to 12 months
Overall survival
Time frame: Up to 30 months after inclusion of the 1st patient
Related Adverse Events in both arms as assessed by National Cancer Institute criteria (National Cancer Institute Common Terminology Criteria for Adverse Events, (NCI CTCAE) version 4).
Time frame: Up to 12 months
Progression free survival not accessible to SIRT
Time frame: Up to 12 months after treatment administration
Post-therapeutic dosimetry measured by Positron emission tomography-computed tomography PET / CT
Dose delivered to the treated liver, the tumors, healthy liver and lings
Time frame: Day one of treatment administration
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