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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02685631
Recruitment Status : Active, not recruiting
First Posted : February 19, 2016
Last Update Posted : September 3, 2020
Sponsor:
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 3, 2020
Study Start Date July 2015
Estimated Primary Completion Date August 2021   (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
Change History
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 * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: September 2, 2020)
1653
Original Estimated Enrollment
 (submitted: February 18, 2016)
400
Estimated Study Completion Date August 2022
Estimated Primary Completion Date August 2021   (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
Removed Location Countries  
 
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
Responsible Party Daniel B. Brown, Vanderbilt-Ingram Cancer Center
Study Sponsor Vanderbilt-Ingram Cancer Center
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Daniel Brown Vanderbilt University/Ingram Cancer Center
PRS Account Vanderbilt-Ingram Cancer Center
Verification Date September 2020