Yttrium Y 90 Resin Microspheres Data Collection in Unresectable Liver Cancer: the RESIN Study
- Conditions
- Localized Non-Resectable Adult Liver Carcinoma
- Interventions
- Other: Yttrium-90 Resin Microspheres
- Registration Number
- NCT02685631
- Lead Sponsor
- Vanderbilt-Ingram Cancer Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1653
- Patients receiving SIR-Spheres therapy to the liver for the first time.
- Provision of written informed consent.
- Age 18 and older.
-
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observational/data registry collection Yttrium-90 Resin Microspheres Patients receiving Yttrium-90 resin microspheres as part of care
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (42)
Sky Ridge Medical Center
🇺🇸Englewood, Colorado, United States
Methodist Health System
🇺🇸Dallas, Texas, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Vanderbilt University/Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
University of Colorado, Denver
🇺🇸Denver, Colorado, United States
The University of Utah
🇺🇸Salt Lake City, Utah, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Northwell Health- Lenox Hill Hospital
🇺🇸New York, New York, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Wake Forest Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Providence Sacred Heart Medical Center and Children's Hospital
🇺🇸Spokane, Washington, United States
Penn State Health Saint Joseph Medical Center
🇺🇸Reading, Pennsylvania, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Stanford University
🇺🇸Stanford, California, United States
Christiana Care Health System
🇺🇸Wilmington, Delaware, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Cancer Treatment Centers of America
🇺🇸Atlanta, Georgia, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Arizona Health Sciences
🇺🇸Tucson, Arizona, United States
University of Miami
🇺🇸Miami, Florida, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Spartanburg Regional Healthcare System
🇺🇸Spartanburg, South Carolina, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States