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

September 3, 2021 updated by: Daniel B. Brown, Vanderbilt-Ingram Cancer Center

Radiation-Emitting SIR-Spheres in Non-resectable (RESIN) Liver Tumor Patient Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1653

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • University of Alabama
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona Health Sciences
    • Arkansas
      • Little Rock, Arkansas, United States
        • University of Arkansas for Medical Sciences
    • California
      • Los Angeles, California, United States
        • Cedars-Sinai Medical Center
      • San Francisco, California, United States
        • University of California, San Francisco
      • San Francisco, California, United States
        • California Pacific Medical Center
      • Stanford, California, United States
        • Stanford University
    • Colorado
      • Denver, Colorado, United States
        • University of Colorado, Denver
      • Englewood, Colorado, United States
        • Sky Ridge Medical Center
    • Delaware
      • Wilmington, Delaware, United States, 19899
        • Christiana Care Health System
    • District of Columbia
      • Washington, District of Columbia, United States
        • Georgetown University
    • Florida
      • Miami, Florida, United States
        • University of Miami
      • Miami, Florida, United States
        • Baptist Hospital of Miami
      • Sarasota, Florida, United States
        • Sarasota Memorial Hospital
      • Tampa, Florida, United States
        • Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, United States
        • Emory University
      • Atlanta, Georgia, United States
        • Piedmont Hospital
      • Atlanta, Georgia, United States
        • Cancer Treatment Centers of America
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Christ Medical Center
    • Kansas
      • Kansas City, Kansas, United States
        • University of Kansas Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States
        • University of Maryland School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States
        • Massachusetts General Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Missouri
      • Saint Louis, Missouri, United States
        • Saint Louis University
    • New York
      • Albany, New York, United States
        • Albany Medical Center
      • Buffalo, New York, United States
        • Roswell Park Cancer Institute
      • New York, New York, United States
        • Northwell Health- Lenox Hill Hospital
    • North Carolina
      • Charlotte, North Carolina, United States
        • Carolinas Medical Center
      • Winston-Salem, North Carolina, United States
        • Wake Forest Medical Center
    • Ohio
      • Cleveland, Ohio, United States
        • Cleveland Clinic
      • Cleveland, Ohio, United States
        • University Hospitals Cleveland Medical Center
    • Oregon
      • Portland, Oregon, United States
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • University of Pennsylvania Cancer Center
      • Reading, Pennsylvania, United States
        • Penn State Health Saint Joseph Medical Center
    • South Carolina
      • Spartanburg, South Carolina, United States
        • Spartanburg Regional Healthcare System
    • South Dakota
      • Sioux Falls, South Dakota, United States
        • Sanford USD Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Dallas, Texas, United States
        • Methodist Health System
      • Houston, Texas, United States
        • Houston Methodist Hospital
    • Utah
      • Salt Lake City, Utah, United States
        • The University of Utah
    • Washington
      • Spokane, Washington, United States
        • Providence Sacred Heart Medical Center and Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with primary and secondary liver cancer receiving SIR Spheres® microspheres (Y90 resin microspheres) treatment as part of their overall oncologic management

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational/data registry collection
Patients receiving Yttrium-90 resin microspheres as part of care
Other: Yttrium-90 Resin Microspheres
Data collection into the RESIN registry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to treatment with Y90 microspheres either as mono therapy or as part of multidisciplinary management of their specific disease
Time Frame: 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.
Up to 1 year after the first treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment related toxicity assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4) measures
Time Frame: 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
Up to 1 year after the first treatment
Overall Survival
Time Frame: 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.
2 years
Time to Progression
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Daniel Brown, Vanderbilt University/Ingram Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

December 19, 2015

First Submitted That Met QC Criteria

February 18, 2016

First Posted (Estimate)

February 19, 2016

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 3, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICCGI1523
  • P30CA068485 (U.S. NIH Grant/Contract)
  • NCI-2015-01837 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • VICC GI 1523 (Other Identifier: Vanderbilt University/Ingram Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We plan on reporting group outcomes by tumor type or subtype. Individual records will be subject to HIPAA rules

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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