Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver (TACOME)

April 22, 2024 updated by: Cigdem Soydal, Ankara University

Radioembolization is an established treatment option for patients with unresectable primary and secondary liver tumors. Microspheres containing 90Y are injected intraarterially to deliver a high radiation dose to the tumors. Despite of our knowledge on the effectiveness of 90Y glass microspheres in the treatment of HCC, literature data on the treatment of metastatic colorectal cancer (mCRC) patients with 90Y glass microspheres is limited. In the recent EANM guideline variable healthy liver doses are recommended for patients with mCRC with an effective tumor dose recommendation based on a study with limited number of patients.

Primary objectives; Investigate effective tumor dose and safe healthy liver dose in radioembolization for colorectal cancer liver metastasis using multicompartment dosimetry Secondary objectives; Investigate dose-response and dose-toxicity relationships, time to progress, concordance between pretreatment and posttreatment dose calculations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

202

Contacts and Locations

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

Study Locations

  • Turkey
      • Adana, Turkey
        • Cukurova University Medical School
      • Ankara, Turkey
        • Ankara University Medical School
      • Ankara, Turkey
        • Hacettepe Univeristy Medical School
      • Istanbul, Turkey
        • Istanbul University Cerrahpasa Medical School
      • Istanbul, Turkey
        • Istanbul University Capa Medical School
      • Istanbul, Turkey
        • Marmara University Medical School
      • Istanbul, Turkey
        • Yeditepe University Medical School
      • İzmir, Turkey
        • Dokuz Eylul University Medical School

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

Adult patients with metastatic colorectal cancer (mCRC) treated using Y90 glass microspheres in lobar or segmental fashion

Description

Inclusion Criteria:

  • over 18 years old
  • histopathologically proven colorectal cancer diagnosis
  • treated with radioembolization for liver metastases with Y90 glass microspheres in lobar or segmental fashion
  • have follow-up data at least 6 months after radioembolization

Exclusion Criteria:

  • no PET-CT, CT or MR of the liver within last 6 weeks prior to radioembolization.

No PET-CT, CT or MR of the liver 2-4 months after radioembolization Poor image quality Previous local treatment or surgery for the liver

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
Observation group
Patients who received radioembolization for colorectal cancer liver metastases
Device: Therasphere
Transarterial radioembolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effective tumor dose and safe healthy liver dose
Time Frame: 3th month after treatment
Compare the mean effective tumor doses effective tumour dose (in Gy) of patients with or without response to radioembolization for colorectal cancer liver metastasis.
3th month after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dose (in Gy) -response and dose (in Gy)-toxicity relationships
Time Frame: 6th month after treatment
Investigate dose-response and dose-toxicity relationships after transarterial radioembolization.
6th month after treatment

Collaborators and Investigators

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

Sponsor

Ankara University

Collaborators

Boston Scientific Corporation

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)

January 15, 2024

Primary Completion (Actual)

March 15, 2024

Study Completion (Actual)

April 15, 2024

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

September 7, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TACOME-TR

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.

No

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.

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