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

Localized Non-Resectable Adult Liver Carcinoma Clinical Trial

— RESiN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02685631
• Other study ID #: VICCGI1523
• Secondary ID: NCI-2015-01837VI
• Status: Completed
• Start date: July 2015
• Est. completion date: August 31, 2021

Study information

• Verified date: September 2021
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1653
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Localized Non-Resectable Adult Liver Carcinoma

Intervention

Other:
• Yttrium-90 Resin Microspheres
Data collection into the RESIN registry

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to treatment with Y90 microspheres either as mono therapy or as part of multidisciplinary management of their specific disease	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	Treatment related toxicity assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4) measures	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
Secondary	Overall Survival	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
Secondary	Time to Progression	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

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial