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Protocol No. UW18110

Principal Investigator Bassetti, Michael

Phase I/II

Age Group Adult

Scope Local

Sponsor Type Institutional

Title A Phase I/II Study of OAR-Based, Dose Escalated SBRT with Real Time Adaptive MRI Guidance for Liver Metastases

Objective The purpose of this research study is to determine the most favorable dose levels of targeted radiation therapy called stereotactic body radiation therapy (SBRT) to treat liver metastases. We are doing this research because long term survival with metastatic liver disease is low and SBRT is one of the leading options of treatment to try to increase survival rates
Radiation therapy focuses radiation delivery to cancer cells but also exposes normal tissue close to the cancer to radiation
This study will try to see what the highest dose of radiation is that we can provide while limiting the effects on surrounding healthy cells

Treatment You will have one radiation treatment every other day over 1.5 to 2 weeks. Treatments will be given Monday through Friday. Each treatment will take approximately one hour. This treatment will start within 4 weeks of signing the consent form

Description Phase I/II Study of OAR-Based, Dose Escalated SBRT with Real Time Adaptive MRI Guidance for Liver Metastases

Key Eligibility
  • For Phase I trial, have a diagnosis of histologically confirmed or clinically suspected metastatic cancer to the liver; for Phase IB trial have have a diagnosis of histologically confirmed or clinically suspected metastatic CRC to the liver
  • Patient must be a candidate for SBRT to at least one intrahepatic lesion but no more than 6 intrahepatic lesions
  • Patient 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 at least 18 years of age
  • Patients may be chemotherapy-na├»ve or have had prior chemotherapy 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 WBRT at the time of registration AND asymptomatic and off systemic corticosteroids and/or enzyme-inducing antiepileptic medications for brain metastases for less than14 days prior to registration
  • Adequate organ function as defined by the protocol
  • Patients 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
  • ECOG Performance Status 0-2
  • Can not be pregnant or breastfeeding and Male and Female of child bearing potential must agree to adequate birth control as defined by the protocol
    EXCLUSION
  • 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 the subject’s 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
  • Patients with Gilbert’s disease or other primary disorders of bilirubin metabolism will not be allowed on the trial
  • Has pre-existing liver disease such that patients are classified as Child Pugh B or worse. If the patient 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
  • Patients with implanted hardware that would preclude MRIs

  • Applicable Disease Sites Breast; Colon and Rectum; Lung

    Status Open

    Participating Institutions UW Hospital and Clinics