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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Center Eugene Marquis

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 [ Time Frame: Day one of treatment administration ]
    Dose delivered to the treated liver, the tumors, healthy liver and lings


Original Secondary Outcome: Same as current

Information By: Center Eugene Marquis

Dates:
Date Received: October 9, 2015
Date Started: December 2015
Date Completion: July 2018
Last Updated: December 2, 2016
Last Verified: September 2016