Status:
RECRUITING
Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)
Lead Sponsor:
Sirtex Medical
Conditions:
Unresectable Hepatocellular Carcinoma (HCC)
Liver Metastases From Colorectal Cancer (mCRC)
Eligibility:
All Genders
18+ years
Brief Summary
This registry seeks to prospectively gather a large repository of comprehensive observational data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable HCC or unresectable liv...
Detailed Description
This is a global, multi-center, prospective, observational cohort study (registry) to assess real-world outcomes in patients with unresectable HCC or unresectable liver metastases from mCRC refractory...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Confirmed diagnosis of:
- Unresectable hepatocellular carcinoma (HCC) Or
- Unresectable liver metastases from colorectal cancer (mCRC) refractory to or intolerant to chemotherapy
- Identified as a candidate for SIR-Spheres treatment as deemed appropriate during the normal course of practice
- Planned to receive SIR-Spheres treatment to the liver for the first time
- Provision of signed patient informed consent
Exclusion
- Prior radiation treatment to the liver
- Caveat:
- Sequential selective internal radiation therapy (SIRT) treatment is allowed
- Patients participating in any interventional clinical trial with an investigational product, device, or procedure
- Need for surrogate consent. Patients who are not able to consent on behalf of themselves are not eligible.
Key Trial Info
Start Date :
June 19 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
845 Patients enrolled
Trial Details
Trial ID
NCT05967143
Start Date
June 19 2023
End Date
June 1 2029
Last Update
November 27 2024
Active Locations (9)
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1
Hôpital Beaujon
Clichy, Cedex, France, 92118
2
Hopital Henri Mondor
Créteil, Paris, France, 94000
3
Hospices Civils de Lyon HCL Centre Hospitalier Lyon-Sud
Pierre-Bénite, Rhône, France, 69495
4
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, Spain, 28220