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Trial record 10 of 46 for:    SIR-Spheres

CIRSE Registry for SIR-Spheres in France (CIRT-FR) (CIRT-FR)

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ClinicalTrials.gov Identifier: NCT03256994
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Cardiovascular and Interventional Radiological Society of Europe

Brief Summary:
Selective Internal Radiation Therapy (SIRT), also known as radioembolisation, is a minimal invasive, endovascular treatment for primary and secondary liver tumours. In France, SIR-Spheres are listed as reimbursable by the national health authorities (Haute Autorité de Santé [HAS]). In order to evaluate the reimbursement after five years, all patients treated with SIR-Spheres will be entered into a registry that collects data on the real-life clinical application of SIRT and reports to the national authorities.

Condition or disease Intervention/treatment
Liver Cancer 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.

In France, SIR-Spheres are listed as reimbursable by the national health authorities (Haute Autorité de Santé [HAS]). In order to evaluate the reimbursement after five years, all patients treated with SIR-Spheres will be entered into a registry that collects data on the real-life clinical application of SIRT and reports to the national authorities.

The goal of the research project is to gain a better understanding of the real-life clinical application of radioembolisation with SIR-Spheres and the impact of the treatment in clinical practice. Secondary objectives will include, safety in terms of adverse events; effectiveness based on overall survival, progression free survival (PFS), hepatic free survival (liver specific PFS); SIRT in relation to surgery and ablation (before and after SIRT treatment) and quality of life.

To better understand the palliative aspect of the treatment, acquisition of the change in quality of life is included by means of EORTC's validated quality of life questionnaire QLQ C30 with accompanying HCC module to measure quality of life in patients with hepatocellular carcinoma.

Besides data collection on the initial treatment, it will be advised to collect follow-up data and quality of life data every three months for a minimum of 24 months after treatment.

CIRT-FR is a post-market, prospective, non-randomized, observational study. Patients are only asked to be enrolled when they are treated with SIR-Spheres microspheres as part of their treatment determined by the treating clinician. In no way will participation of the patient in the registry impact their treatment plan, or influence the quality of the treatment.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: CIRSE Registry for SIR-Spheres in France (CIRT-FR)
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer


Intervention Details:
  • 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. Overall Survival (OS) [ Time Frame: min 24 months ]
    Survival in months from time of SIR-Spheres treatment

  2. Incidence of Treatment-Emergent Adverse Events (Safety) [ Time Frame: min 24 months ]
    Incidence of Treatment-Emergent Adverse Events

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

  4. Progression free survival (PFS) [ Time Frame: min 24 months ]
    Progression free survival in months from time of treatment

  5. Liver specific progression free survival [ Time Frame: min 24 months ]
    Progression free survival in the liver in months from time of treatment



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
Sampling Method:   Non-Probability Sample
Study Population

In a general manner and according to the Intent-To-Treat principle, no subject will be excluded from the analysis. The primary and secondary endpoint analysis will include all enrolled subjects in CIRT-FR.

However, patients who are considered for SIR-Spheres treatment but for whom it was decided that they would not be treated will not be included in the analysis.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Consent denied


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): NCT03256994


Contacts
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Contact: Agnes Walk +43 1 904 2003 52 walk@cirse.org
Contact: Niels de Jong +43 1 904 2003 47 dejong@cirse.org

Locations
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France
CHU d'Angers Recruiting
Angers, France
Contact: Antoine Bouvier, Dr         
Hôpital Beaujon Recruiting
Clichy, France
Contact: Maxime Ronot, Dr         
Chu de Dijon Recruiting
Dijon, France
Contact: Romaric Loffroy, Dr         
Centre Léon Bérard Recruiting
Lyon, France
Contact: Charles Mastier, Dr         
CHRU de Strasbourg Recruiting
Strasbourg, France
Contact: Michel Greget, Dr         
Sponsors and Collaborators
Cardiovascular and Interventional Radiological Society of Europe
Investigators
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Study Chair: José I Bilbao, Prof Cardiovascular and Interventional Radiological Society of Europe

Additional Information:

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Responsible Party: Cardiovascular and Interventional Radiological Society of Europe
ClinicalTrials.gov Identifier: NCT03256994     History of Changes
Other Study ID Numbers: CIRT-FR
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases