CIRSE Registry for SIR-Spheres Therapy

NCT02305459 | Completed DMC

• 1 other identifier: CIRSECIRT
• Study Type: observational
• Target: 1,051
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Carcinoma

Keywords

SIRT; microcatheter; primary liver tumor; secondary liver tumor; radioembolisation; QLQ-C30; CIRSE

Outcome Measures

Primary Outcomes (1)

• Description of the clinical context in which SIR-Spheres are applied

  Context of systemic therapy; intention of treatment; prior hepatic procedures; post hepatic procedures

  Baseline, follow-up every 3 months until 24 months

Secondary Outcomes (5)

• Adverse events

  Every 3 months until 24 months

• QLQ-C30

  Every 3 months until 24 months

• Overall survival

  Every 3 months until 24 months

• PFS

  Every 3 months until 24 months

• Hepatic PFS

  Every 3 months until 24 months

Study Arms (1)

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; Behavioral: QLQ-C30 with HCC module

Interventions

Yttrium-90 loaded SIR-Spheres microspheres DEVICE

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.

Patients treated with Radioembolisation

QLQ-C30 with HCC module BEHAVIORAL

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.

Patients treated with Radioembolisation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Under 18 years

Sponsors & Collaborators

• Cardiovascular and Interventional Radiological Society of Europe: lead

Study Sites (1)

Cardiovascular and Interventional Radiological Society of Europe

Vienna, 1010, Austria

Location

Related Publications (4)

• Reimer P, Vilgrain V, Arnold D, Balli T, Golfieri R, Loffroy R, Mosconi C, Ronot M, Sengel C, Schaefer N, Maleux G, Munneke G, Peynircioglu B, Sangro B, Kaufmann N, Urdaniz M, Pereira H, de Jong N, Helmberger T. Factors Impacting Survival After Transarterial Radioembolization in Patients with Unresectable Intrahepatic Cholangiocarcinoma: A Combined Analysis of the Prospective CIRT Studies. Cardiovasc Intervent Radiol. 2024 Mar;47(3):310-324. doi: 10.1007/s00270-023-03657-x. Epub 2024 Feb 6.

  PMID: 38321223 DERIVED

• Kolligs F, Arnold D, Golfieri R, Pech M, Peynircioglu B, Pfammatter T, Ronot M, Sangro B, Schaefer N, Maleux G, Munneke G, Pereira H, Zeka B, de Jong N, Helmberger T; CIRT Principal Investigators. Factors impacting survival after transarterial radioembolization in patients with hepatocellular carcinoma: Results from the prospective CIRT study. JHEP Rep. 2022 Nov 25;5(2):100633. doi: 10.1016/j.jhepr.2022.100633. eCollection 2023 Feb.

  PMID: 36593888 DERIVED

• 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.

  PMID: 32959085 DERIVED

• 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.

  PMID: 32319960 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Thomas Helmberger, Prof

  München Klinik Bogenhausen,Englschalkinger Str. 77, D-81925 München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: December 2, 2014
• Study Start: November 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2020
• Last Updated: January 21, 2020

Record last verified: 2020-01

Locations

AU (1)