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

Sponsor

Vanderbilt-Ingram Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT02685631

Collaborator

National Cancer Institute (NCI) (NIH)

1,653

Enrollment

Locations

Duration (Months)

39.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Localized Non-Resectable Adult Liver Carcinoma	Other: Yttrium-90 Resin Microspheres

Detailed Description

PRIMARY OBJECTIVES:

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 Design

Study Type:

Observational

Actual Enrollment :

1653 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Aug 31, 2020

Actual Study Completion Date :

Aug 31, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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:

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.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States
2	University of Arizona Health Sciences	Tucson	Arizona	United States	85724
3	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States
4	Cedars-Sinai Medical Center	Los Angeles	California	United States
5	California Pacific Medical Center	San Francisco	California	United States
6	University of California, San Francisco	San Francisco	California	United States
7	Stanford University	Stanford	California	United States
8	University of Colorado, Denver	Denver	Colorado	United States
9	Sky Ridge Medical Center	Englewood	Colorado	United States
10	Christiana Care Health System	Wilmington	Delaware	United States	19899
11	Georgetown University	Washington	District of Columbia	United States
12	Baptist Hospital of Miami	Miami	Florida	United States
13	University of Miami	Miami	Florida	United States
14	Sarasota Memorial Hospital	Sarasota	Florida	United States
15	Tampa General Hospital	Tampa	Florida	United States
16	Cancer Treatment Centers of America	Atlanta	Georgia	United States
17	Emory University	Atlanta	Georgia	United States
18	Piedmont Hospital	Atlanta	Georgia	United States
19	Advocate Christ Medical Center	Oak Lawn	Illinois	United States	60453
20	University of Kansas Medical Center	Kansas City	Kansas	United States
21	Ochsner Clinic Foundation	New Orleans	Louisiana	United States
22	University of Maryland School of Medicine	Baltimore	Maryland	United States
23	Massachusetts General Hospital	Boston	Massachusetts	United States
24	University of Minnesota	Minneapolis	Minnesota	United States	55455
25	Saint Louis University	Saint Louis	Missouri	United States
26	Albany Medical Center	Albany	New York	United States
27	Roswell Park Cancer Institute	Buffalo	New York	United States
28	Northwell Health- Lenox Hill Hospital	New York	New York	United States
29	Carolinas Medical Center	Charlotte	North Carolina	United States
30	Wake Forest Medical Center	Winston-Salem	North Carolina	United States
31	Cleveland Clinic	Cleveland	Ohio	United States
32	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States
33	Oregon Health & Science University	Portland	Oregon	United States
34	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States
35	Penn State Health Saint Joseph Medical Center	Reading	Pennsylvania	United States
36	Spartanburg Regional Healthcare System	Spartanburg	South Carolina	United States
37	Sanford USD Medical Center	Sioux Falls	South Dakota	United States
38	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee	United States	37232
39	Methodist Health System	Dallas	Texas	United States
40	Houston Methodist Hospital	Houston	Texas	United States
41	The University of Utah	Salt Lake City	Utah	United States
42	Providence Sacred Heart Medical Center and Children's Hospital	Spokane	Washington	United States