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

Completed

• Conditions: Localized Non-Resectable Adult Liver Carcinoma

• Registration Number: NCT02685631
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-12-19
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-19
• Primary Completion: 2020-08-31
• Study Completion: 2021-08-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-03
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1653

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to treatment with Y90 microspheres either as mono therapy or as part of multidisciplinary management of their specific disease	Up to 1 year after the first treatment	Response to treatment is the initial measure of treatment efficacy. This can be measured using objective criteria such as the modified Response Evaluation Criteria in Solid Tumors (mRECIST) or European Association for Study of Liver Cancer (EASL) criteria depending on local policy and tumor type.

Secondary Outcome Measures

Name	Time	Method
Treatment related toxicity assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4) measures	Up to 1 year after the first treatment	Overall toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4) measures. Tracking this outcome can help define optimal combinations of Y90 plus systemic or biologic therapy to be used in formal research studies in the future
Overall Survival	2 years	As noted above, overall survival is the optimal outcome measure with any oncologic therapy. However, the majority of patients will receive additional therapy after progressing on a given treatment regimen. For this reason, overall survival assessment with Y90 is a secondary, rather than a primary assessment endpoint in this registry study.
Time to Progression	2 years	Overall survival is the definitive measure of any oncologic therapy. However, many if not all patients receive other treatments at the time of tumor progression. For this reason TTP may be the most accurate measure of oncologic efficacy following Y90 treatment.

Trial Locations

Locations (42)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

University of Arizona Health Sciences; 🇺🇸 Tucson, Arizona, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Stanford University; 🇺🇸 Stanford, California, United States

University of Colorado, Denver; 🇺🇸 Denver, Colorado, United States

Sky Ridge Medical Center; 🇺🇸 Englewood, Colorado, United States

Christiana Care Health System; 🇺🇸 Wilmington, Delaware, United States

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