RECRUITING

Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Patients With Colorectal Liver Metastases

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A prospective, interventional study evaluating the safety of Y-90 TARE for tumor control of the right side and induction of left liver hypertrophy as part of a planned single-stage or two-stage hepatectomy for patients with CLM and insufficient FLR at the time of presentation.

Official Title

Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Patients With Colorectal Liver Metastases

Quick Facts

Study Start:2022-11-16

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05195710

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Borderline resectable unresectable (due to insufficient liver volume at presentation) colorectal liver metastases with potential curative intent, as determined by the surgeon and multidisciplinary team * Anticipated standardized FLR (sFLR) that would require right portal vein embolization (PVE) to increase the sFLR prior to either a single major hepatectomy, or prior to the second stage hepatectomy as part of a two-stage hepatectomy strategy, all in the setting of curative-intent resection(s). This evaluation will be documented in the clinical chart * Received at least four cycles (or two months) of chemotherapy * Willing, able and mentally competent to provide written informed consent * Medically and physically operable as determined by the surgeon	* Extrahepatic disease that precludes intended curative intent treatment sequencing (treatable primary tumor and lung metastases allowed). "Treatable" is defined as having an intended future plan for local therapy (surgery, radiation, or ablation) as determined by the patient's medical oncologist and surgical oncologist * Projected sFLR before Y-90 of \<20% (starting with sFLR that is unrealistic for improvement to ≥30%) * Performance status limitations (Karnofsky \<80%, ECOG \>1) * Portal hypertension and/or cirrhosis * Starting total bilirubin \>1.3 mg/dL (except if patient has Gilbert's Disease) * CEA \>200 after 4 cycles of chemotherapy upon restaging visit * Clinical progression of disease on imaging and/or tumor marker after 4 cycles of chemotherapy that is clinically judged by surgical oncology and medical oncology to preclude surgical resection * Platelet count \<100,000/µL * Albumin \<3.5 g/dl * Symptomatic primary colon or rectal cancer (without pre-existing proximal diverting ostomy) * Pregnant or breast-feeding patient * Other medical or clinical contraindications to liver surgery * Non-English-speaking participants

Inclusion Criteria

Exclusion Criteria

* Borderline resectable unresectable (due to insufficient liver volume at presentation) colorectal liver metastases with potential curative intent, as determined by the surgeon and multidisciplinary team
* Anticipated standardized FLR (sFLR) that would require right portal vein embolization (PVE) to increase the sFLR prior to either a single major hepatectomy, or prior to the second stage hepatectomy as part of a two-stage hepatectomy strategy, all in the setting of curative-intent resection(s). This evaluation will be documented in the clinical chart
* Received at least four cycles (or two months) of chemotherapy
* Willing, able and mentally competent to provide written informed consent
* Medically and physically operable as determined by the surgeon

* Extrahepatic disease that precludes intended curative intent treatment sequencing (treatable primary tumor and lung metastases allowed). "Treatable" is defined as having an intended future plan for local therapy (surgery, radiation, or ablation) as determined by the patient's medical oncologist and surgical oncologist
* Projected sFLR before Y-90 of \<20% (starting with sFLR that is unrealistic for improvement to ≥30%)
* Performance status limitations (Karnofsky \<80%, ECOG \>1)
* Portal hypertension and/or cirrhosis
* Starting total bilirubin \>1.3 mg/dL (except if patient has Gilbert's Disease)
* CEA \>200 after 4 cycles of chemotherapy upon restaging visit
* Clinical progression of disease on imaging and/or tumor marker after 4 cycles of chemotherapy that is clinically judged by surgical oncology and medical oncology to preclude surgical resection
* Platelet count \<100,000/µL
* Albumin \<3.5 g/dl
* Symptomatic primary colon or rectal cancer (without pre-existing proximal diverting ostomy)
* Pregnant or breast-feeding patient
* Other medical or clinical contraindications to liver surgery
* Non-English-speaking participants

Contacts and Locations

Study Contact

Ching-Wei Tzeng, MD

CONTACT

(713) 792-0386

cdtzeng@mdanderson.org

Principal Investigator

Ching-Wei Tzeng, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Ching-Wei Tzeng, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

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 Registration Dates

Study Start Date2022-11-16

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2022-11-16

Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

Metastases