Status:
RECRUITING
Preoperative Y-90 Radioembolization for Tumor Control and Future Liver Remnant Hypertrophy in Patients With Colorectal Liver Metastases
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Sirtex Medical
Conditions:
Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 hepate...
Detailed Description
Primary Objective: To examine the safety and feasibility of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with C...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05195710
Start Date
November 16 2022
End Date
March 31 2026
Last Update
November 7 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030