NCT02582034

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

Selective Internal Radiation Therapy for Hepatocellular Carcinomas With Yttrium-90 Loaded Microspheres: Optimized Dosimetry Versus Standard Dosimetry

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Center Eugene Marquis · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adenoma, Liver Cell

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2015-10-21
• Last updated: 2019-01-31

Locations

4 sites across 1 country: France