Internal Radiation Therapy for Hepatocellular Carcinomas With Therasphere: Optimized Dosimetry Versus Standard Dosimetry

PHASE2CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

December 31, 2018

Study Completion Date

December 31, 2018

Conditions
Adenoma, Liver Cell
Interventions
RADIATION

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."

RADIATION

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."

Trial Locations (4)

34925

CHU Saint Eloi, Montpellier

35042

Centre Eugène Marquis, Rennes

94000

CHU Henri Mondor, Créteil

Unknown

Gustave Roussy, Villejuif

All Listed Sponsors
lead

Center Eugene Marquis

OTHER

NCT02582034 - Internal Radiation Therapy for Hepatocellular Carcinomas With Therasphere: Optimized Dosimetry Versus Standard Dosimetry | Biotech Hunter | Biotech Hunter