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

Recruiting now · Not applicable

Conditions studied: Liver Metastases, Stereotactic Body Radiation Therapy, MRI-guided Treatment

In brief

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.

Key facts

Study ID: NCT04020276
Run by: University of Wisconsin, Madison
People needed: 32
Starts: 2019-11-04
Expected to finish: 2028-12-01
Last updated by the study team: 2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
International Normalized Ratio (INR) or Prothrombin Time (PT) greater than or equal to 1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Activated Partial Thromboplastin Time (aPTT) greater than or equal to 1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
For participants enrolled on the liver dose escalation arm, screening labs must be consistent with Child Pugh class A unless therapeutic anticoagulation places them in Child Pugh B. In that case, trial entry or exclusion will be at the discretion of the treating physician.
Have a performance status of 2 or less on the Eastern Cooperative Oncology Group (ECOG) performance scale.
Life expectancy of > 12 weeks.
Women of childbearing potential (WOCP) should have a negative urine or serum pregnancy test prior to initiation of radiation therapy. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
WOCP must not be pregnant or breast-feeding.
WOCP must be willing to use an effective method of birth control such as an oral, implantable, injectable, or transdermal hormonal contraceptive, an intrauterine device (IUD), use of a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence for the duration of the radiotherapy and 60 days thereafter.
NOTE: A person of childbearing potential is anyone (regardless of sexual orientation, gender identity, having undergone a tubal ligation, or remaining celibate by choice) who was born with a uterus and at least one ovary and meets both of the following criteria:
Is post-menarcheal (i.e., has had at least one prior menses)

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.
For participants in the liver dose escalation arm only, has pre-existing liver disease such that patients are classified as Child Pugh B or worse. If the participant is anti-coagulated such that their INR places them in the CP-B classification, exclusion or inclusion will be at the discretion of the treating physician.
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.

Where it is running

University of Wisconsin — Madison, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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