OAR-Based, Dose Escalated SBRT With Real Time Adaptive MRI Guidance for Liver Metastases

NCT04020276 | Recruiting DMC FDA Device

• 6 other identifiers: UW18110NCI-2019-04726SMPH/HUMAN ONCOLOGY/HUMAN ONCOA5333002019-0373Protocol Version 10/28/2025
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to identify a safe maximum tolerated dose level for MRI-guided Stereotactic Body Radiation Therapy (SBRT) treatment of bowel and liver metastases, respectively. Eligible participants will be on study for up to 12 months.

Conditions

Liver Metastases; MRI-guided Treatment; Stereotactic Body Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Acute Dose Limiting Toxicity (DLT)

  Dose limiting toxicity (DLT) will be defined as grade 3 or greater\* non-hematologic toxicity attributable to radiation therapy, and occurring within 4 weeks after the completion of SBRT. \*With the exception of liver function tests, which are allowed up to and including grade 3

  Up to 4 weeks

Secondary Outcomes (4)

• Progression Free Survival (PFS)

  Up to 5 years

• Overall Survival (OS)

  Up to 5 years

• Local Control Rates

  up to 2 years

• Change in Quality of Life (QoL)

  Baseline, 2 months (1 month post treatment follow-up)

Study Arms (1)

MRI-Guided SBRT Dose Escalation

EXPERIMENTAL

Treatment on MRI Linac with SBRT in 5 fractions with adaptive planning, maximum dose 80 Gy Dose Escalation Bowel Pathway, V34 \< 0.5cc Dose Escalation Liver Pathway, 700 cc \< 16 Gy

Radiation: SBRT

Interventions

SBRT RADIATION

Participants will receive 5 fractions of radiation, which will be delivered 2-3 times per week. SBRT should be complete in a 1.5 to 2 week time frame. There should be a minimum of 12 hours between treatments.

MRI-Guided SBRT Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnosis of histologically confirmed or clinically suspected metastatic cancer to the liver.
• Participant must be a candidate for SBRT to at least one intrahepatic lesion but no more than 6 intrahepatic lesions.
• Participant must be a candidate for treatment on the ViewRay treatment unit. Must be screened to rule out implants and devices that are not MRI compatible.
• Be willing and able to provide written informed consent.
• Participants may be therapy-naïve or have had prior systemic therapy up to two weeks prior to study entry.
• No active central nervous system (CNS) metastatic disease. NOTE: Subjects with CNS involvement must meet all of the following to be eligible:
• At least 28 days from prior definitive treatment of their CNS disease by surgical resection, SBRT or Whole Brain Radiation Therapy (WBRT) at the time of registration
• AND asymptomatic and off systemic corticosteroids and/or enzyme-inducing antiepileptic medications for brain metastases for \>14 days prior to registration.
• Demonstrate adequate organ function as defined in the following table; all screening labs should be performed within 28 days of SBRT treatment initiation.
• Platelet count greater than or equal to 50000 /µL
• Absolute Neutrophil Count (ANC) greater than or equal to 1000 /µL
• Hemoglobin (Hgb) greater than or equal to 8 g/dL or greater than or equal to 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
• Serum creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) Creatinine/Calculated creatinine clearance (CrCl) greater than or equal to 30 mL/min for subject with creatinine levels greater than 1.5 X institutional upper limit of normal (ULN)
• Bilirubin greater than or equal to 1. 5 × ULN OR direct bilirubin greater than or equal to ULN for participants with total bilirubin levels greater than 1.5 ULN
• Aspartate aminotransferase (AST) and ALT (SGPT) greater than or equal to 5 × ULN

You may not qualify if:

• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the initiation of SBRT.
• History of a second invasive cancer in the last 3 years (except for appropriately treated low-risk prostate cancer, treated non-melanoma skin cancer, appropriately treated ductal carcinoma in situ or early stage invasive carcinoma of breast appropriately treated in situ/early stage cervical/endometrial cancer.
• Has an active infection requiring systemic therapy.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with follow up scans or visits.
• Has a primary tumor histology of germ cell tumor, leukemia, or lymphoma.
• Has a primary liver cancer such as cholangiocarcinoma or hepatocellular carcinoma.
• Has had prior radiation therapy that significantly overlaps with the liver.
• Has a diagnosis of Crohn's disease, ulcerative colitis, or scleroderma.
• Participants with Gilbert's disease or other primary disorders of bilirubin metabolism will not be allowed on the trial.
• Pregnancy or women of childbearing potential and men who are sexually active and refuse to use medically acceptable forms of contraception.
• Participants with implanted hardware that would preclude MRIs.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

RECRUITING

Related Links

• University of Wisconsin Carbone Cancer Center

Study Officials

• Michael Bassetti, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer Connect

CONTACT

800-622-8922; clinicaltrials@cancer.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 4+4 dose-escalation design - patients will be treated to a maximum tolerated dose using MRI-guided SBRT with real time adaptation.

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 16, 2019
• Study Start: November 4, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)