Clinical trial NCT06030232: Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver
Official title: Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transarterial Radioembolization
Lead sponsor: Ankara University
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2023-09-08
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with metastatic colorectal cancer (mCRC) treated using Y90 glass microspheres in lobar or segmental fashion

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: effective tumor dose and safe healthy liver dose
timeFrame: 3th month after treatment
Secondary outcomes:
measure: dose (in Gy) -response and dose (in Gy)-toxicity relationships
timeFrame: 6th month after treatment
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University Medical School
city: Ankara
country: Turkey
facility: Ankara University Medical School
city: Ankara
country: Turkey
facility: Hacettepe Univeristy Medical School
city: Istanbul
country: Turkey
facility: Istanbul University Capa Medical School
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical School
city: Istanbul
country: Turkey
facility: Marmara University Medical School
city: Istanbul
country: Turkey
facility: Yeditepe University Medical School
city: İzmir
country: Turkey
facility: Dokuz Eylul University Medical School
Study officials:
References: