Yttrium Y 90 Resin Microspheres Data Collection in Unresectable Liver Cancer: the RESIN Study (RESiN)
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|ClinicalTrials.gov Identifier: NCT02685631|
Recruitment Status : Recruiting
First Posted : February 19, 2016
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment|
|Localized Non-Resectable Adult Liver Carcinoma||Other: Yttrium-90 Resin Microspheres|
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.
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|
|Estimated Enrollment :||1000 participants|
|Official Title:||Radiation-Emitting SIR-Spheres in Non-resectable (RESIN) Liver Tumor Patient Study|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2021|
Observational/data registry collection
Patients receiving Yttrium-90 resin microspheres as part of care
Other: Yttrium-90 Resin Microspheres
Data collection into the RESIN registry
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02685631
|Contact: Vanderbilt-Ingram Service for Timely Access||800-811-8480|
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|Principal Investigator:||Daniel Brown||Vanderbilt University/Ingram Cancer Center|