SIRtain Registry: SIR-Spheres for unresectable liver tumours
Research type
Research Study
Full title
Observational Study to Assess Real-World Outcomes in Patients with Unresectable Liver Tumors Initiating Treatment with SIR-Spheres® (Y-90 resin microspheres) (SIRtain Registry)
IRAS ID
326095
Contact name
Rohini Sharma
Contact email
Sponsor organisation
Sirtex Technology Pty Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 3 months, 1 days
Research summary
Hepatocellular carcinoma (HCC) accounts for more than 85% of reported cases of liver cancer and is the fourth most common cause of cancer-related death. Despite guidance on the management of HCC, there is still a need for safe and effective treatments that improve survival, tumour control and quality of life.
SIR-Spheres are radioactive beads that are injected into the blood supply of tumours. Once in the tumour, SIR-Spheres deliver a high dose of beta irradiation to the tumour cells.
The SIRtain Registry is a prospective observational study to assess the real-world effectiveness and safety of SIR-Spheres treatment and the impact on health related quality of life and healthcare resource utilisation.
Patients over the age of 18 with HCC or cancer that has spread to the liver from the colon or rectum that cannot be removed surgically and has stopped responding to treatment may be eligible. The decision for patients to be treated with SIR-Spheres will have been taken prior to approaching patients to participate in the registry.
Patients will be followed as per standard of care for up to 2 years. Clinical assessments will be performed as per standard of care and data will be collected at Baseline and at Months 3, 6, 9, 12, 18 and 24 after SIR-Sphere treatment. Patients will be asked to complete questionnaires about their quality of life at Baseline, Week 2 and Months 3, 6, 9, 12, 18 and 24.
This study is sponsored by Sirtex Technology Pty Ltd. Approximately 845 patients will participate in this registry worldwide with 80 patients from 3 hospitals in the UK.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
23/EM/0104
Date of REC Opinion
25 May 2023
REC opinion
Further Information Favourable Opinion