Yttrium Y 90 Resin Microspheres Data Collection in Unresectable Liver Cancer: the RESIN Study (RESiN)

Vanderbilt University Medical Center

Status: Completed

Conditions: Localized Non-Resectable Adult Liver Carcinoma

Treatments: Other: Yttrium-90 Resin Microspheres

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02685631

NCI-2015-01837 (Registry Identifier)

P30CA068485 (U.S. NIH Grant/Contract)

VICC GI 1523 (Other Identifier)

VICCGI1523

Details and patient eligibility

About

This research registry studies Yttrium Y 90 resin microspheres in collecting data from patients with liver cancer not capable of being removed by surgery (unresectable) for the radiation-emitting Selective Internal Radiation-Spheres (SIR-spheres) in non-resectable (RESIN) liver tumor registry. The information generated will help doctors better understand treatment patterns involving Y90 therapy, gain additional insights in the long-term outcomes for patients, as well as guide future research for using Y90 therapy, especially for those conditions where data is currently very limited or lacking.

Full description

PRIMARY OBJECTIVES:

I. The principal objective of the RESIN registry is to evaluate response to therapy using objective response criteria such as modified Response Evaluation Criteria in Solid Tumors (mRECIST) or European Association for Study of the Liver (EASL). The response criteria used will depend on tumor type treated and local policies as this is a registry and not a formal research study. Secondary criteria include overall survival, time to progression (TTP) and toxicity.

OUTLINE:

Patients receiving Yttrium Y90 resin microspheres treatment as part of their overall oncologic management are added in the RESIN registry database to collect and document information including: patient demographics (gender/age), previous oncologic treatments, details of Yttrium Y90 resin microspheres treatment, and to track outcomes and complications.

Enrollment: 1,653 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients receiving SIR-Spheres therapy to the liver for the first time.
• Provision of written informed consent.
• Age 18 and older.

Exclusion criteria

1. Prior completion of Y90 therapy to the liver (SIR-Spheres, TheraSpheres, or any other liver-targeted therapy involving the use of radiation-emitting spheres).

   -Patients who have received Y90 treatment in the past and who are returning for another Y90 treatment are ineligible, even if new areas are being targeted.

2. Need for surrogate consent. Patients unable to consent on their own behalves are not eligible for this study.

Trial design

1,653 participants in 1 patient group

Observational/data registry collection

Description:

Patients receiving Yttrium-90 resin microspheres as part of care

Treatment:

Other: Yttrium-90 Resin Microspheres