Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.

Conditions

• Liver Malignancy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Yttrium-90 — DRUG
  Radioactive isotope Y-90 at day 0, administered by selective internal radiation therapy (SIRT)
• Selective Internal Radiation Therapy — DEVICE
  SIRT at day 0, to administer Yttrium-90 (Y-90) Theraspheres
• Stereotactic Body Radiation Therapy — RADIATION
  3-5 fractions over 1-2 weeks, after Y-90 SIRT
• PET/CT — DIAGNOSTIC_TEST
  Within 3 hours of completing Y-90 SIRT
• Therasphere — DEVICE
  Glass microspheres containing Y-90, administered at day 0 by SIRT

Study Details

This study will investigate the combination of Ytrium-90 (Y-90) Selective Internal Radiation Therapy (SIRT) followed by Stereotactic Body Radiation Therapy (SBRT). Y-90 SIRT alone or SBRT alone are standard procedures used in the treatment of liver cancer. This study will assess the combination of Y-90 SIRT and SBRT and obtain preliminary information about the side effects and safety of the combination therapy. Additionally, this is the first time that Y-90 PET-CT imaging will be included in planning for SBRT.

Key Dates

Start date

Sep 16, 2020

Status verified

Jul 2025

Primary completion

May 31, 2028

Completion

Nov 30, 2028

Study Design

Enrollment

70 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Y-90 SIRT followed by SBRT
  Y-90 SIRT followed by SBRT

Primary Outcome Measure

Change in Child-Turcotte-Pugh (CTP) score >= 2 points from baseline [ Time Frame: Up to 6 months after SBRT ]

Central Contacts

• Cancer AnswerLine
  1-800-865-1125
  [email protected]

Locations (1)

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