Observational Study to Assess Real-World Outcomes in Patients With Unresectable Liver Tumors Initiating Treatment With SIR-Spheres (Y-90 Resin Microspheres) (SIRtain Registry)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Unresectable Hepatocellular Carcinoma (HCC)
- Sponsor
- Sirtex Medical
- Enrollment
- 845
- Locations
- 9
- Primary Endpoint
- Liver PFS (LPFS)
- Status
- Recruiting
- Last Updated
- last year
Overview
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 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
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 to or intolerant to chemotherapy who have been prescribed SIRT with SIR-Spheres per medical decision. The study will be conducted through the involvement of approximately 845 patients from up to 44 sites in an estimated 10 countries.
Investigators
Eligibility Criteria
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
- •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.
Outcomes
Primary Outcomes
Liver PFS (LPFS)
Time Frame: 24months from LPI
Progression-free survival (PFS)
Time Frame: 24months from LPI
Objective response rate (ORR) and liver response rate (LRR)
Time Frame: 24months from LPI
Overall survival (OS)
Time Frame: 24months from LPI
Duration of response (DoR)
Time Frame: 24months from LPI
Change scores from baseline to follow-up timepoints of the EQ-5D-5L
Time Frame: 24months from LPI
The (EurolQol) EQ-5D-5L is comprised of five questions on mobility, self-care, pain, usual activities, and psychological status with 5 level answers, 5 being extreme and 1 minimum.
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)
Time Frame: 24months from LPI
The 30 EORTC QLQ-C30 items constitute consist of 9 domains: physical function, role function, cognitive function, emotional function, social function, fatigue, pain, nausea and vomiting, and global health status. Items are answered on a scale of 1 to 4 or 1 to 7.
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)
Time Frame: 24months from LPI
The EORTC QLQ-HCC18 instrument consists of 6 symptom scales and 2 single items: that measures fatigue, body image, jaundice, nutrition, pain, fever, sexual interest and abdominal swelling. Scores are based on a 4-point Likert scale (with 1 = 'not at all' to 4 = 'very much').
Secondary Outcomes
- Healthcare Resource Utilization summarized at follow-up timepoints(24months from LPI)
- SAEs/SADE's rates(24months from LPI)
- Subsequent hepatic procedures summarized at follow-up timepoints(24months from LPI)