Trial Title:
Observational SIR-Spheres Study for the Treatment of Unresectable Liver Tumors (SIRtain Registry)
NCT ID:
NCT05967143
Condition:
Unresectable Hepatocellular Carcinoma (HCC)
Liver Metastases From Colorectal Cancer (mCRC)
Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Carcinoma, Hepatocellular
Conditions: Keywords:
Liver metastases from colorectal cancer (mCRC)
Unresectable Hepatocellular carcinoma (HCC)
SIR-Spheres microspheres
Y-90 resin microspheres
SIRT
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
SIRT
Description:
Selective internal radiation therapy with SIR-Spheres Y90 resin microspheres.
Arm group label:
Patients with unresectable HCC or unresectable liver metastases from mCRC
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.
Criteria for eligibility:
Study pop:
Approximately 845 patients for whom their physicians plan to utilize SIR-Spheres in a
Primary Care Clinic.
Sampling method:
Non-Probability Sample
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
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hôpital Beaujon
Address:
City:
Clichy
Zip:
92118
Country:
France
Status:
Recruiting
Investigator:
Last name:
Mohamed Bouattour
Email:
Principal Investigator
Facility:
Name:
Hopital Henri Mondor
Address:
City:
Créteil
Zip:
94000
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Hélène Regnault
Email:
Principal Investigator
Facility:
Name:
Hospices Civils de Lyon HCL Centre Hospitalier Lyon-Sud
Address:
City:
Pierre-Bénite
Zip:
69495
Country:
France
Status:
Recruiting
Investigator:
Last name:
Nicolas Jacquet-Francillon
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Puerta de Hierro - Majadahonda
Address:
City:
Majadahonda
Zip:
28220
Country:
Spain
Status:
Not yet recruiting
Investigator:
Last name:
Lourdes Gutierrez
Email:
Principal Investigator
Facility:
Name:
Hospital General Universitario Gregorio Marañon
Address:
City:
Madrid
Zip:
28009
Country:
Spain
Status:
Not yet recruiting
Investigator:
Last name:
Pilar Garcia Alfonso
Email:
Principal Investigator
Facility:
Name:
Hospital Clinico Universitario de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Not yet recruiting
Investigator:
Last name:
Paloma Lluch
Email:
Principal Investigator
Facility:
Name:
The Christie Hospital
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Saifee Mullamitha
Email:
Principal Investigator
Facility:
Name:
Kings College Hospital
Address:
City:
London
Zip:
SE5 9RS
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Paul Ross
Email:
Principal Investigator
Facility:
Name:
Hammersmith Hospital
Address:
City:
London
Zip:
W12 OHS
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Rohini Sharma
Email:
Principal Investigator
Start date:
June 19, 2023
Completion date:
June 2029
Lead sponsor:
Agency:
Sirtex Medical
Agency class:
Industry
Source:
Sirtex Medical
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05967143
