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.
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
1,653
Data collection into the RESIN registry
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
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.
Time frame: Up to 1 year after the first treatment
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
Time frame: Up to 1 year after the first treatment
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.
Time frame: 2 years
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.
Time frame: 2 years
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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
...and 32 more locations