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

• ClinicalTrials.gov Identifier: NCT02685631
• Recruitment Status: Completed
• First Posted: February 19, 2016
• Last Update Posted: September 5, 2021
• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Daniel B. Brown, Vanderbilt-Ingram Cancer Center

Tracking Information

• First Submitted Date: December 19, 2015
• First Posted Date: February 19, 2016
• Last Update Posted Date: September 5, 2021
• Study Start Date: July 2015
• Actual Primary Completion Date: August 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 18, 2016)

Response to treatment with Y90 microspheres either as mono therapy or as part of multidisciplinary management of their specific disease [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 18, 2016)

• Treatment related toxicity assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4) measures [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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
• Condition: Localized Non-Resectable Adult Liver Carcinoma

Intervention

Other: Yttrium-90 Resin Microspheres

Data collection into the RESIN registry

Study Groups/Cohorts

Observational/data registry collection

Patients receiving Yttrium-90 resin microspheres as part of care

Intervention: Other: Yttrium-90 Resin Microspheres

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 2, 2020): 1653
• Original Estimated Enrollment (submitted: February 18, 2016): 400
• Actual Study Completion Date: August 31, 2021
• Actual Primary Completion Date: August 31, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02685631
• Other Study ID Numbers: VICCGI1523; NCI-2015-01837 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); VICC GI 1523 ( Other Identifier: Vanderbilt University/Ingram Cancer Center ); P30CA068485 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: We plan on reporting group outcomes by tumor type or subtype. Individual records will be subject to HIPAA rules

• Current Responsible Party: Daniel B. Brown, Vanderbilt-Ingram Cancer Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Vanderbilt-Ingram Cancer Center
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Daniel Brown; Vanderbilt University/Ingram Cancer Center

• PRS Account: Vanderbilt-Ingram Cancer Center
• Verification Date: September 2021