2015-07
2020-08-31
2021-08-31
1653
NCT02685631
Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
OBSERVATIONAL
Yttrium Y 90 Resin Microspheres Data Collection in Unresectable Liver Cancer: the RESIN Study
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2015-12-19 | N/A | 2021-09-03 |
2016-02-18 | N/A | 2021-09-05 |
2016-02-19 | N/A | 2021-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Observational/data registry collection Patients receiving Yttrium-90 resin microspheres as part of care | OTHER: Yttrium-90 Resin Microspheres
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Response to treatment with Y90 microspheres either as mono therapy or as part of multidisciplinary management of their specific disease | 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. | Up to 1 year after the first treatment |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Treatment related toxicity assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4) measures | 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 | Up to 1 year after the first treatment |
| Overall Survival | 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. | 2 years |
| Time to Progression | 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. | 2 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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