CIRSE Registry for SIR-Spheres Therapy (CIRT)
|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: NCT02305459|
Recruitment Status : Active, not recruiting
First Posted : December 2, 2014
Last Update Posted : November 1, 2018
|Condition or disease||Intervention/treatment|
|Liver Carcinoma||Device: Yttrium-90 loaded SIR-Spheres microspheres Behavioral: QLQ-C30 with HCC module|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||1051 participants|
|Target Follow-Up Duration:||24 Months|
|Official Title:||CIRSE Registry for SIR-Spheres Therapy|
|Actual Study Start Date :||November 2014|
|Actual Primary Completion Date :||January 1, 2018|
|Estimated Study Completion Date :||January 1, 2020|
Patients treated with Radioembolisation
All Patients treated with Radioembolisation with yttrium-90 loaded SIR-Spheres microspheres are asked to be enrolled. In no way will participation in the registry influence the way in which the patient is treated or will it influence the quality of the treatment.
In order to measure the palliative aspect of RE with SIR-Spheres microspheres, CIRT will incorporate a quality-of-life questionnaire. CIRT will be using EORTC's QLQ-C30 with the Hepatocellular carcinoma (HCC) Module to measure changes in the quality of life of the patient.
Device: Yttrium-90 loaded SIR-Spheres microspheres
Selective internal radiation therapy (SIRT), also called radioembolisation (RE), with SIR-Spheres microspheres is an endovascular procedure, included within the interventional oncologic technologies to treat primary and secondary liver tumours. Using a microcatheter, a precise dose of resin microspheres is released in the hepatic artery, where they are carried into the arterioles and selectively lodge in the tumour microvasculature. The microspheres are loaded with the radioactive yttrium-90, a high-energy beta-emitting isotope with a half-life of 64.1 hours. SIR-Spheres microspheres are manufactured by Sirtex Medical.
Behavioral: QLQ-C30 with HCC module
In order to measure the palliative aspect of RE with SIR-Spheres microspheres, CIRT will incorporate a quality-of-life questionnaire. CIRT will be using EORTC's QLQ-C30 with HCC Module to measure changes in the quality of life of the patient. The quality-of-life questionnaire will be offered to the patient before the treatment, shortly after the treatment (as soon as possible) and at every follow-up. Filling out the quality-of-life questionnaire is entirely voluntary for the patient.
- Description of the clinical context in which SIR-Spheres are applied [ Time Frame: Baseline, follow-up every 3 months until 24 months ]Context of systemic therapy; intention of treatment; prior hepatic procedures; post hepatic procedures
- Adverse events [ Time Frame: Every 3 months until 24 months ]Adverse events per follow-up
- QLQ-C30 [ Time Frame: Every 3 months until 24 months ]Quality of life using QLQ-C30 from baseline until 24 months
- Overall survival [ Time Frame: Every 3 months until 24 months ]Time till death
- PFS [ Time Frame: Every 3 months until 24 months ]Time to progression
- Hepatic PFS [ Time Frame: Every 3 months until 24 months ]Time to progression
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): NCT02305459
|Cardiovascular and Interventional Radiological Society of Europe|
|Vienna, Austria, 1010|
|Principal Investigator:||José Ignacio Bilbao, Prof||CIRSE Cardiovascular and Interventional Radiological Society of Europe|