CIRSE Registry for SIR-Spheres Therapy (CIRT)

• ClinicalTrials.gov Identifier: NCT02305459
• Recruitment Status: Completed
• First Posted: December 2, 2014
• Last Update Posted: January 21, 2020
• Sponsor: Cardiovascular and Interventional Radiological Society of Europe
• Information provided by (Responsible Party): Cardiovascular and Interventional Radiological Society of Europe

Tracking Information

• First Submitted Date: November 11, 2014
• First Posted Date: December 2, 2014
• Last Update Posted Date: January 21, 2020
• Actual Study Start Date: November 2014
• Actual Primary Completion Date: January 1, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 30, 2018)

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

• Original Primary Outcome Measures (submitted: November 27, 2014): Change from Baseline in Quality of Life questionnaire QLQ-C30 with HCC Module [ Time Frame: Baseline, on average every 3 months up to 1 year ]

Current Secondary Outcome Measures (submitted: October 30, 2018)

• 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

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: CIRSE Registry for SIR-Spheres Therapy
• Official Title: CIRSE Registry for SIR-Spheres Therapy
• 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
• 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]
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: 24 Months
• Biospecimen: Not Provided
• 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.
• Condition: Liver Carcinoma

Intervention

• 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.

Study Groups/Cohorts

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.

Interventions:

• Device: Yttrium-90 loaded SIR-Spheres microspheres
• Behavioral: QLQ-C30 with HCC module

Publications *

• Helmberger T, Golfieri R, Pech M, Pfammatter T, Arnold D, Cianni R, Maleux G, Munneke G, Pellerin O, Peynircioglu B, Sangro B, Schaefer N, de Jong N, Bilbao JI; On behalf of the CIRT Steering Committee; On behalf of the CIRT Principal Investigators. Clinical Application of Trans-Arterial Radioembolization in Hepatic Malignancies in Europe: First Results from the Prospective Multicentre Observational Study CIRSE Registry for SIR-Spheres Therapy (CIRT). Cardiovasc Intervent Radiol. 2021 Jan;44(1):21-35. doi: 10.1007/s00270-020-02642-y. Epub 2020 Sep 21.
• Helmberger T, Arnold D, Bilbao JI, de Jong N, Maleux G, Nordlund A, Peynircioglu B, Sangro B, Sharma RA, Walk A. Clinical Application of Radioembolization in Hepatic Malignancies: Protocol for a Prospective Multicenter Observational Study. JMIR Res Protoc. 2020 Apr 22;9(4):e16296. doi: 10.2196/16296.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 30, 2018): 1051
• Original Estimated Enrollment (submitted: November 27, 2014): 1200
• Actual Study Completion Date: January 1, 2020
• Actual Primary Completion Date: January 1, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT02305459
• Other Study ID Numbers: CIRSECIRT
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Cardiovascular and Interventional Radiological Society of Europe
• Original Responsible Party: Same as current
• Current Study Sponsor: Cardiovascular and Interventional Radiological Society of Europe
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Thomas Helmberger, Prof; München Klinik Bogenhausen,Englschalkinger Str. 77, D-81925 München

• PRS Account: Cardiovascular and Interventional Radiological Society of Europe
• Verification Date: January 2020