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CIRSE Registry for SIR-Spheres Therapy (CIRT)

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ClinicalTrials.gov Identifier: NCT02305459
Recruitment Status : Active, not recruiting
First Posted : December 2, 2014
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Cardiovascular and Interventional Radiological Society of Europe

Brief Summary:
The administration of SIR-Spheres microspheres (yttrium-90 resin microspheres) is a form of selective internal radiation therapy (SIRT) for the treatment of patients with primary and secondary liver tumours. The primary objective is to observe the real-life clinical application of radioembolisation with SIR-Spheres and the impact of the treatment in clinical practice. Secondary objectives are to observe safety and effectiveness of SIR-Spheres treatment in terms of adverse events, Overall Survival (OS), Progression-free survival (PFS), technical considerations, liver PFS and Quality of Life (QoL) + subgroup analyses

Condition or disease Intervention/treatment
Liver Carcinoma Device: Yttrium-90 loaded SIR-Spheres microspheres Behavioral: QLQ-C30 with HCC module

Detailed Description:
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. Following administration, 94% of the radiation is delivered in 11 days. Previous reports on the safety and efficacy of yttrium-90 resin microspheres for the treatment of primary and secondary liver tumours are very promising. In order to further improve the understanding of this therapy in its true clinical setting, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) initiated the CIRSE Registry for SIR-Spheres Therapy (CIRT), a phase 4 observational study that aims to collect robust data on the real-life clinical practice of radioembolisation with SIR-Spheres microspheres. Further, using the quality of life questionnaire QLQ-C30 with its hepatocellular carcinoma module (developed and verified by the European Organisation of Research and Treatment of Cancer (EORTC)), CIRT aims to collect data on the quality of life of patients treated with SIR-Spheres microspheres.

Study Type : Observational [Patient Registry]
Actual Enrollment : 1051 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Yttrium

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Every 3 months until 24 months ]
    Adverse events per follow-up

  2. QLQ-C30 [ Time Frame: Every 3 months until 24 months ]
    Quality of life using QLQ-C30 from baseline until 24 months

  3. Overall survival [ Time Frame: Every 3 months until 24 months ]
    Time till death

  4. PFS [ Time Frame: Every 3 months until 24 months ]
    Time to progression

  5. Hepatic PFS [ Time Frame: Every 3 months until 24 months ]
    Time to progression



Information from the National Library of Medicine

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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
Study Population
Patients are only asked to be enrolled when they are treated with SIR-Spheres microspheres as part of the treatment determined by the treating clinician.
Criteria

Inclusion Criteria:

  • Treatment of liver tumour with SIR-spheres microspheres
  • Primary or secondary liver tumours
  • Signed informed consent form
  • 18 years or older

Exclusion criteria

  • Under 18 years

Information from the National Library of Medicine

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


Locations
Austria
Cardiovascular and Interventional Radiological Society of Europe
Vienna, Austria, 1010
Sponsors and Collaborators
Cardiovascular and Interventional Radiological Society of Europe
Investigators
Principal Investigator: José Ignacio Bilbao, Prof CIRSE Cardiovascular and Interventional Radiological Society of Europe

Responsible Party: Cardiovascular and Interventional Radiological Society of Europe
ClinicalTrials.gov Identifier: NCT02305459     History of Changes
Other Study ID Numbers: CIRSECIRT
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

Keywords provided by Cardiovascular and Interventional Radiological Society of Europe:
SIRT
microcatheter
primary liver tumor
secondary liver tumor
radioembolisation
QLQ-C30
CIRSE

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases