Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with unresectable HCC or unresectable liver metastases from mCRC This cohort will include patients with unresectable HCC or unresectable liver metastases from mCRC refractory to or intolerant to chemotherapy, who have been prescribed selective internal radiation therapy (SIRT) with SIR-Spheres per medical decision. |
Device: SIRT
Selective internal radiation therapy with SIR-Spheres Y90 resin microspheres.
|
Outcome Measures
Primary Outcome Measures
- 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').
Secondary Outcome Measures
- SAEs/SADE's rates [24months from LPI]
Serious adverse events (SAEs)/serious adverse device effects (SADEs) rates
- Subsequent hepatic procedures summarized at follow-up timepoints [24months from LPI]
Subsequent hepatic procedures like number and type of retreatment and surgery are summarized at follow-up timepoints
- Healthcare Resource Utilization summarized at follow-up timepoints [24months from LPI]
The total HCRU of each time point specified in the protocol will be summarized using descriptive statistics.
Eligibility Criteria
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
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Identified as a candidate for SIR-Spheres treatment as deemed appropriate during the normal course of practice
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Planned to receive SIR-Spheres treatment to the liver for the first time
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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
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Need for surrogate consent. Patients who are not able to consent on behalf of themselves are not eligible.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
| 5 | Hospital General Universitario Gregorio Marañon | Madrid | Spain | 28009 | |
| 6 | Hospital Clinico Universitario de Valencia | Valencia | Spain | 46010 | |
| 7 | The Christie Hospital | Manchester | Lancashire | United Kingdom | M20 4BX |
| 8 | Kings College Hospital | London | United Kingdom | SE5 9RS | |
| 9 | Hammersmith Hospital | London | United Kingdom | W12 OHS |
Sponsors and Collaborators
- Sirtex Medical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STX2501