Clinical trial NCT02685631: Yttrium Y 90 Resin Microspheres Data Collection in Unresectable Liver Cancer: the RESIN Study
Official title: Radiation-Emitting SIR-Spheres in Non-resectable (RESIN) Liver Tumor Patient Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Localized Non-Resectable Adult Liver Carcinoma
Keywords: Hepatocellular carcinoma
Colorectal cancer
Neuroendocrine tumor
Cholangiocarcinoma
Breast cancer
Tumor of unknown primary
Pancreatic cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-02-19
Enrollment: 1653
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Response to treatment with Y90 microspheres either as mono therapy or as part of multidisciplinary management of their specific disease
timeFrame: Up to 1 year after the first treatment
Secondary outcomes:
measure: Treatment related toxicity assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4) measures
timeFrame: Up to 1 year after the first treatment
measure: Overall Survival
timeFrame: 2 years
measure: Time to Progression
timeFrame: 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Tucson
country: United States
facility: University of Arizona Health Sciences
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Denver
country: United States
facility: University of Colorado, Denver
state: Colorado
city: Englewood
country: United States
facility: Sky Ridge Medical Center
state: Colorado
city: Wilmington
country: United States
facility: Christiana Care Health System
state: Delaware
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Cancer Treatment Centers of America
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Northwell Health- Lenox Hill Hospital
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: Reading
country: United States
facility: Penn State Health Saint Joseph Medical Center
state: Pennsylvania
city: Spartanburg
country: United States
facility: Spartanburg Regional Healthcare System
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center
state: South Dakota
city: Nashville
country: United States
facility: Vanderbilt University/Ingram Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: Methodist Health System
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: The University of Utah
state: Utah
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center and Children's Hospital
state: Washington
Study officials:
affiliation: Vanderbilt University/Ingram Cancer Center
name: Daniel Brown
role: PRINCIPAL_INVESTIGATOR
References:
citation: Emmons EC, Bishay S, Du L, Krebs H, Gandhi RT, Collins ZS, O'Hara R, Akhter NM, Wang EA, Grilli C, Brower JS, Peck SR, Petroziello M, Abdel Aal AK, Golzarian J, Kennedy AS, Matsuoka L, Sze DY, Brown DB. Survival and Toxicities after 90Y Transarterial Radioembolization of Metastatic Colorectal Cancer in the RESIN Registry. Radiology. 2022 Oct;305(1):228-236. doi: 10.1148/radiol.220387. Epub 2022 Jun 28.
citation: Wong TY, Zhang KS, Gandhi RT, Collins ZS, O'Hara R, Wang EA, Vaheesan K, Matsuoka L, Sze DY, Kennedy AS, Brown DB. Long-term outcomes following 90Y Radioembolization of neuroendocrine liver metastases: evaluation of the radiation-emitting SIR-spheres in non-resectable liver tumor (RESiN) registry. BMC Cancer. 2022 Mar 1;22(1):224. doi: 10.1186/s12885-022-09302-z.