About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Yttrium-90 (Y-90) resin microspheres
Treatment groups
Sponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
Sirtex Medical
Collaborator