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

July 31, 2023 updated by: Sirtex Medical

Observational Study to Assess Real-World Outcomes in Patients With Unresectable Liver Tumors Initiating Treatment With SIR-Spheres (Y-90 Resin Microspheres) (SIRtain Registry)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

845

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Cedex
      • Clichy, Cedex, France, 92118
        • Recruiting
        • Hopital Beaujon
        • Principal Investigator:
          • Mohamed Bouattour
    • Paris
      • Créteil, Paris, France, 94000
        • Not yet recruiting
        • Hôpital Henri Mondor
        • Principal Investigator:
          • Hélène Regnault
    • Rhône
      • Pierre-Bénite, Rhône, France, 69495
        • Recruiting
        • Hospices Civils de Lyon HCL Centre Hospitalier Lyon-Sud
        • Principal Investigator:
          • Nicolas Jacquet-Francillon
  • Spain
      • Madrid, Spain, 28009
        • Not yet recruiting
        • Hospital General Universitario Gregorio Maranon
        • Principal Investigator:
          • Pilar Garcia Alfonso
      • Valencia, Spain, 46010
        • Not yet recruiting
        • Hospital Clínico Universitario de Valencia
        • Principal Investigator:
          • Paloma Lluch
    • Madrid
      • Majadahonda, Madrid, Spain, 28220
        • Not yet recruiting
        • Hospital Universitario Puerta de Hierro - Majadahonda
        • Principal Investigator:
          • Lourdes Gutierrez
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Not yet recruiting
        • Kings College Hospital
        • Principal Investigator:
          • Paul Ross
      • London, United Kingdom, W12 OHS
        • Not yet recruiting
        • Hammersmith Hospital
        • Principal Investigator:
          • Rohini Sharma
    • Lancashire
      • Manchester, Lancashire, United Kingdom, M20 4BX
        • Not yet recruiting
        • The Christie Hospital
        • Principal Investigator:
          • Saifee Mullamitha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Approximately 845 patients for whom their physicians plan to utilize SIR-Spheres in a Primary Care Clinic.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 24months from LPI
24months from LPI
Liver PFS (LPFS)
Time Frame: 24months from LPI
24months from LPI
Overall survival (OS)
Time Frame: 24months from LPI
24months from LPI
Objective response rate (ORR) and liver response rate (LRR)
Time Frame: 24months from LPI
24months from LPI
Duration of response (DoR)
Time Frame: 24months from LPI
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.
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)
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.
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)
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').
24months from LPI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SAEs/SADE's rates
Time Frame: 24months from LPI
Serious adverse events (SAEs)/serious adverse device effects (SADEs) rates
24months from LPI
Subsequent hepatic procedures summarized at follow-up timepoints
Time Frame: 24months from LPI
Subsequent hepatic procedures like number and type of retreatment and surgery are summarized at follow-up timepoints
24months from LPI
Healthcare Resource Utilization summarized at follow-up timepoints
Time Frame: 24months from LPI
The total HCRU of each time point specified in the protocol will be summarized using descriptive statistics.
24months from LPI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sirtex Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2023

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STX2501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Unresectable Hepatocellular Carcinoma (HCC)

Clinical Trials on SIRT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe