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

NCT02685631

Description:

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.

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Recruiting

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: VICCGI1523
  • SECONDARY ID: NCI-2015-01837
  • SECONDARY ID: VICC GI 1523
  • SECONDARY ID: P30CA068485
  • NCT ID: NCT02685631

Conditions

  • Localized Non-Resectable Adult Liver Carcinoma

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Observational/data registry collectionPatients receiving Yttrium-90 resin microspheres as part of care

    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.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    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
    Safety Issue:
    Description: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

    Measure: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
    Safety Issue:
    Description: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
    Measure:Overall Survival
    Time Frame:2 years
    Safety Issue:
    Description: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.
    Measure:Time to Progression
    Time Frame:2 years
    Safety Issue:
    Description: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.

    Details

    Phase:N/A
    Primary Purpose:Observational
    Overall Status:Recruiting
    Lead Sponsor:Vanderbilt-Ingram Cancer Center

    Trial Keywords

    • Hepatocellular carcinoma
    • Colorectal cancer
    • Neuroendocrine tumor
    • Cholangiocarcinoma
    • Breast cancer
    • Tumor of unknown primary
    • Pancreatic cancer

    Last Updated

    February 6, 2017