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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIRT | Device | Selective internal radiation therapy with SIR-Spheres Y90 resin microspheres. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 24months from LPI |
| 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) | 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. | 24months from LPI |
| 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) | 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'). |
| Measure | Description | Time Frame |
|---|---|---|
| SAEs/SADE's rates | Serious adverse events (SAEs)/serious adverse device effects (SADEs) rates | 24months from LPI |
| Subsequent hepatic procedures summarized at follow-up timepoints | Subsequent hepatic procedures like number and type of retreatment and surgery are summarized at follow-up timepoints |
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Inclusion Criteria:
Exclusion Criteria:
Caveat:
Sequential selective internal radiation therapy (SIRT) treatment is allowed
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Approximately 845 patients for whom their physicians plan to utilize SIR-Spheres in a Primary Care Clinic.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janet Bell | Contact | 781-721-3840 | jbell@sirtex.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Beaujon | Recruiting | Clichy | Cedex | 92118 | France |
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| 24months from LPI |
| 24months from LPI |
| Healthcare Resource Utilization summarized at follow-up timepoints | The total HCRU of each time point specified in the protocol will be summarized using descriptive statistics. | 24months from LPI |
| Hopital Henri Mondor | Not yet recruiting | Créteil | Paris | 94000 | France |
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| Hospices Civils de Lyon HCL Centre Hospitalier Lyon-Sud | Recruiting | Pierre-Bénite | Rhône | 69495 | France |
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| Hospital Universitario Puerta de Hierro - Majadahonda | Not yet recruiting | Majadahonda | Madrid | 28220 | Spain |
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| Hospital General Universitario Gregorio Marañon | Not yet recruiting | Madrid | 28009 | Spain |
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| Hospital Clinico Universitario de Valencia | Not yet recruiting | Valencia | 46010 | Spain |
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| The Christie Hospital | Not yet recruiting | Manchester | Lancashire | M20 4BX | United Kingdom |
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| Kings College Hospital | Not yet recruiting | London | SE5 9RS | United Kingdom |
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| Hammersmith Hospital | Not yet recruiting | London | W12 OHS | United Kingdom |
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