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New treatment option for Liver Metastases
Official title OAR-Based, Dose Escalated SBRT With Real Time Adaptive MRI Guidance for Liver Metastases
ClinicalTrials.gov ID: NCT04020276
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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.
You likely can't join if
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used...
- History of a second invasive cancer in the last 3 years (except for appropriately treated low-risk prostate cancer, treated non-melanoma skin 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...
- 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.
See the full eligibility criteria
Who can join
- 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: people 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...
- 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...
- 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...
- 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...
- 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...
- Is post-menarcheal (i.e., has had at least one prior menses)
- Has not undergone a hysterectomy or bilateral oophorectomy or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
What rules you out
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.