Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry) (NCT05967143) | Clinical Trial Compass
RecruitingNot Applicable
Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)
France, Spain845 participantsStarted 2023-06-19
Plain-language 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 liver metastases from mCRC refractory to or intolerant to chemotherapy, in order to assess clinical response in a real-world setting and further validate the safe and appropriate use of SIR-Spheres
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Progression-free survival (PFS)
Timeframe: 24months from LPI
2
Liver PFS (LPFS)
Timeframe: 24months from LPI
3
Overall survival (OS)
Timeframe: 24months from LPI
4
Objective response rate (ORR) and liver response rate (LRR)
Timeframe: 24months from LPI
5
Duration of response (DoR)
Timeframe: 24months from LPI
6
Change scores from baseline to follow-up timepoints of the EQ-5D-5L
Timeframe: 24months from LPI
7
Change scores from baseline to follow-up timepoints of the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30)
Timeframe: 24months from LPI
8
Change scores from baseline to follow-up timepoints of the European Organization for Research and Treatment of Cancer Quality of Life Hepatocellular Carcinoma module (EORTC QLQ-HCC18)