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A Randomized Phase 2 Study of Two Radiation Dose Schedules of Stereotactic Body Radiotherapy (SBRT) to Lung Metastases < 5cm in Dimension (NCT03029416)

30 Gy single fraction of SBRT for lung metastases will result in comparable oncologic outcomes to 18Gy in three fractions (or dosing to a BED </-100Gy at the discretion of the radiation oncologist) with respect to disease control and toxicity.
  • Radiation: Stereotactic Body Radiation Therapy
    Stereotactic Body Radiation Therapy using different fractionation schedules
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Histological confirmation of malignant carcinoma/sarcoma (any site) with metastasis to lung.
    • Patients must not be eligible for therapy with curative intent (i.e. surgery, radiation, etc).
    • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
    • Age ≥18 years
    • ECOG performance status >/= 2 (Karnofsky≥60%)).
    • Ability to understand and the willingness to sign a written informed consent document.
    Exclusion Criteria:
    • Patients with more than >/=3 metastatic lung lesions or any one lesion greater than 5 cm. and/or extensive metastatic disease outside the chest.
    • Patients who are receiving any other investigational agents.
    • Patients with active systemic, pulmonary, or pericardial infection.
    • Pregnant or lactating women
    • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
    • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    • Chemotherapy concurrent with SBRT is not allowed
    Using two different doses of SBRT, this study will examine the 6-month local disease control rate (LDCR) of the SBRT-treated metastasis to determine the optimum dosing for SBRT in pulmonary metastases. This will allow us to establish baseline SBRT data, from which we will develop a second trial to examine sequencing of immunotherapy with SBRT.

    1 locations

    United States (1)
    • University of Kentucky
      not yet recruiting
      Lexington, Kentucky, United States, 40536
    Status:
    not yet recruiting
    Type:
    Interventional
    Phase:
    Start:
    31 March, 2017
    Updated:
    19 January, 2017
    Participants:
    50
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