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

Primary Purpose

Metastases

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Yttrium-90 (Y-90) resin microspheres

About this trial

This is an interventional treatment trial for Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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
- Willing, able and mentally competent to provide written informed consent
- Medically and physically operable as determined by the surgeon

Exclusion Criteria:

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 <150,000/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

Sites / Locations

M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yttrium-90

Arm Description

Help to control the tumor(s) on the right side of the liver while the remaining left side of the liver, which is clear of cancer, grows.

Outcomes

Primary Outcome Measures

The evaluation from using the 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 CLM.

The evaluation of using the safety 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 CLM.

Secondary Outcome Measures

Full Information

NCT ID

NCT05195710

First Posted

November 24, 2021

Last Updated

October 4, 2023

Sponsor

M.D. Anderson Cancer Center

Collaborators

Sirtex Medical

1. Study Identification

Unique Protocol Identification Number

NCT05195710

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 16, 2022 (Actual)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

Sirtex Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 hepatectomy for patients with CLM and insufficient FLR at the time of presentation.

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 CLM. Secondary Objectives: To describe changes in liver volume after Y-90 TARE, including: The kinetic growth rate (KGR) of the FLR Degree of hypertrophy 6 weeks after TARE Atrophy of targeted right hemi-liver from TARE date to date of surgery To describe additional interventional procedures needed to induce additional hypertrophy if insufficient hypertrophy from Y-90 TARE To assess the proportion of TARE patients who undergo attempted and complete curative-intent resection of CLM To assess measures of disease control, including: Tumor marker trend RECIST/mRECIST criteria CT morphologic response PET CT response To describe Patient Reported Outcomes using MDASI-GI To assess FLR liver quality, right-sided surgical adhesions from TARE intraoperatively To describe dosimetry of individual liver lesions - using SPECT/CT, CT, and pathology correlation To describe change in liver function measured by the pre- and post-TARE HIDA SPECT/CT scans and hepatic function blood tests

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Yttrium-90

Arm Type

Experimental

Arm Description

Help to control the tumor(s) on the right side of the liver while the remaining left side of the liver, which is clear of cancer, grows.

Intervention Type

Drug

Intervention Name(s)

Yttrium-90 (Y-90) resin microspheres

Intervention Description

Given by scan

Primary Outcome Measure Information:

Title

The evaluation from using the 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 CLM.

Time Frame

through study completion, an average of 1 year

Title

The evaluation of using the safety 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 CLM.

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion 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 Willing, able and mentally competent to provide written informed consent Medically and physically operable as determined by the surgeon Exclusion Criteria: 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 <150,000/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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ching-Wei Tzeng, MD

Phone

(713) 792-0386

cdtzeng@mdanderson.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ching-Wei Tzeng, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ching-Wei David Tzeng, MD

First Name & Middle Initial & Last Name & Degree

Ching-Wei David Tzeng, MD

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

M D Anderson Cancer Center

Learn more about this trial

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

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