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 : Completed
First Posted : February 19, 2016
Last Update Posted : September 5, 2021
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|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|
|Actual Enrollment :||1653 participants|
|Official Title:||Radiation-Emitting SIR-Spheres in Non-resectable (RESIN) Liver Tumor Patient Study|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||August 31, 2020|
|Actual Study Completion Date :||August 31, 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Patients receiving SIR-Spheres therapy to the liver for the first time.
- Provision of written informed consent.
- Age 18 and older.
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.
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
|Principal Investigator:||Daniel Brown||Vanderbilt University/Ingram Cancer Center|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Daniel B. Brown, Principal Investigator, Vanderbilt-Ingram Cancer Center|
|Other Study ID Numbers:||
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 )
|First Posted:||February 19, 2016 Key Record Dates|
|Last Update Posted:||September 5, 2021|
|Last Verified:||September 2021|
|Individual Participant Data (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|
Tumor of unknown primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases