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NCT Number: NCT05967143

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

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Key information

Conditions

Unresectable Hepatocellular Carcinoma (HCC) Liver Metastases From Colorectal Cancer (mCRC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Beaujon, Clichy, Cedex, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SIRT

Device

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

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: 24months from LPI

  2. Liver PFS (LPFS)

    Time frame: 24months from LPI

  3. Overall survival (OS)

    Time frame: 24months from LPI

  4. Objective response rate (ORR) and liver response rate (LRR)

    Time frame: 24months from LPI

  5. Duration of response (DoR)

    Time frame: 24months from LPI

  6. 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.

  7. 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.

  8. 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').

Secondary outcomes

  1. SAEs/SADE's rates

    Time frame: 24months from LPI

    Serious adverse events (SAEs)/serious adverse device effects (SADEs) rates

  2. 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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Janet Bell

CONTACT

[email protected]

781-721-3840

Sponsors and collaborators

Lead sponsor

Sirtex Medical

Industry

Registry information

Official study title

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

Acronym: SIRtain

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Aug 1, 2023
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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