Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)

Condition(s) studied

Investigational drug(s) / intervention(s)

SIRT: Selective internal radiation therapy with SIR-Spheres Y90 resin microspheres.

Study 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

Eligibility

Primary outcome measure(s)

• Progression-free survival (PFS) — 24months from LPI
• Liver PFS (LPFS) — 24months from LPI
• Overall survival (OS) — 24months from LPI
• Objective response rate (ORR) and liver response rate (LRR) — 24months from LPI
• Duration of response (DoR) — 24months from LPI
• Change scores from baseline to follow-up timepoints of the EQ-5D-5L — 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) — 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) — 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').

Trial sites (9)