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Localized Non-Resectable Adult Liver CarcinomaRESiNNCT02685631

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

An observational study of Localized Non-Resectable Adult Liver Carcinoma, run by Vanderbilt-Ingram Cancer Center at 42 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Yttrium-90 Resin Microspheres
How many people
1,653 participants
Where
42 sitesUnited States
Study dates
Jul 2015to 31 Aug 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with primary and secondary liver cancer receiving SIR Spheres® microspheres (Y90 resin microspheres) treatment as part of their overall oncologic management

Who may be able to join

  • Patients receiving SIR-Spheres therapy to the liver for the first time.
  • Provision of written informed consent.
  • Age 18 and older.

Who cannot join

  • 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.

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

United States42 sites

  • Albany Medical Center

    Albany, New York

  • Cancer Treatment Centers of America

    Atlanta, Georgia

  • Emory University

    Atlanta, Georgia

  • Piedmont Hospital

    Atlanta, Georgia

  • University of Maryland School of Medicine

    Baltimore, Maryland

  • University of Alabama

    Birmingham, Alabama

  • Massachusetts General Hospital

    Boston, Massachusetts

  • Roswell Park Cancer Institute

    Buffalo, New York

  • Carolinas Medical Center

    Charlotte, North Carolina

  • Cleveland Clinic

    Cleveland, Ohio

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio

  • Methodist Health System

    Dallas, Texas

  • University of Colorado, Denver

    Denver, Colorado

  • Sky Ridge Medical Center

    Englewood, Colorado

  • Houston Methodist Hospital

    Houston, Texas

  • University of Kansas Medical Center

    Kansas City, Kansas

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas

  • Cedars-Sinai Medical Center

    Los Angeles, California

  • Baptist Hospital of Miami

    Miami, Florida

  • University of Miami

    Miami, Florida

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Ochsner Clinic Foundation

    New Orleans, Louisiana

  • Northwell Health- Lenox Hill Hospital

    New York, New York

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania

  • Oregon Health & Science University

    Portland, Oregon

  • Penn State Health Saint Joseph Medical Center

    Reading, Pennsylvania

  • The University of Utah

    Salt Lake City, Utah

  • California Pacific Medical Center

    San Francisco, California

  • University of California, San Francisco

    San Francisco, California

  • Sarasota Memorial Hospital

    Sarasota, Florida

  • Sanford USD Medical Center

    Sioux Falls, South Dakota

  • Spartanburg Regional Healthcare System

    Spartanburg, South Carolina

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington

  • Saint Louis University

    St Louis, Missouri

  • Stanford University

    Stanford, California

  • Tampa General Hospital

    Tampa, Florida

  • University of Arizona Health Sciences

    Tucson, Arizona, 85724

  • Georgetown University

    Washington D.C., District of Columbia

  • Christiana Care Health System

    Wilmington, Delaware, 19899

  • Wake Forest Medical Center

    Winston-Salem, North Carolina

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
Yttrium-90 Resin Microspheres
Keywords
Hepatocellular carcinoma, Colorectal cancer, Neuroendocrine tumor, Cholangiocarcinoma, Breast cancer, Tumor of unknown primary, Pancreatic cancer
Medical subject headings
Carcinoma, Hepatocellular, Colorectal Neoplasms, Neuroendocrine Tumors, Cholangiocarcinoma, Breast Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yttrium-90 Resin MicrospheresOther

    Data collection into the RESIN registry

Study groups in NCT02685631
Study groupRoleWhat they receive
Observational/data registry collectionPatients receiving Yttrium-90 resin microspheres as part of care
Receives: Other: Yttrium-90 Resin Microspheres

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 1 year after the first treatment

Secondary outcomes (3)

  1. 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

    Measured: Up to 1 year after the first treatment

  2. 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.

    Measured: 2 years

  3. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2016 (estimated)
  2. Study startJul 2015
  3. Primary completion31 Aug 2020
  4. Study completion31 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,653 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02685631
Sponsor's protocol ID
VICCGI1523
Other IDs
NCI-2015-01837, VICC GI 1523, P30CA068485
Acronym
RESiN
Status last verified
Sep 2021
First submitted
19 Dec 2015
Last updated
5 Sep 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided: We plan on reporting group outcomes by tumor type or subtype. Individual records will be subject to HIPAA rules

Publications

  • Zhou W, Du L, Brown DB, Shah RP, Sze DY. Outcomes Analysis of Yttrium-90 Radioembolization for Tumors Other Than Metastatic Colorectal Cancer from the Radiation-Emitting SIR-Spheres in Nonresectable (RESiN) Registry. J Vasc Interv Radiol. 2024 Nov;35(11):1591-1600.e3. doi: 10.1016/j.jvir.2024.07.006. Epub 2024 Jul 14.

    PubMed 39009301

  • 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.

    PubMed 35762890

  • 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.

    PubMed 35232410

Questions about this trial

What is this clinical trial studying?

An observational study of Localized Non-Resectable Adult Liver Carcinoma, run by Vanderbilt-Ingram Cancer Center at 42 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02685631, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.

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