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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

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

Details

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.

Keywords

Localized Non-Resectable Adult Liver Carcinoma Hepatocellular carcinoma Colorectal cancer Neuroendocrine tumor Cholangiocarcinoma Breast cancer Tumor of unknown primary Pancreatic cancer

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  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.

Locations

  • California Pacific Medical Center accepting new patients
    San Francisco, California, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vanderbilt-Ingram Cancer Center
Links
Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
ID
NCT02685631
Study Type
Observational
Last Updated
February 1, 2017