56
Participants
Start Date
December 31, 2015
Primary Completion Date
December 31, 2018
Study Completion Date
December 31, 2018
Optimized Internal Radiation Therapy
"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."
Standard Internal Radiation Therapy
"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 Saint Eloi, Montpellier
Centre Eugène Marquis, Rennes
CHU Henri Mondor, Créteil
Gustave Roussy, Villejuif
Center Eugene Marquis
OTHER