Phase
Condition
Brain Metastases
Neoplasm Metastasis
Treatment
brain metastases radiosurgery
Clinical Study ID
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Stated willingness to comply with all study procedures and availability for theduration of the study
Male or female, aged 19 and older
Brain metastases diagnosis not requiring retreatment to the same tumor
For females of reproductive potential should undergo pregnancy testing as per UABRadiation Oncology standard policies
Ability of subject or Legally Authorized Representative (LAR)) to understand and thewillingness to sign a written informed consent document.
Exclusion
Exclusion Criteria:
Current use of cytotoxic chemotherapy within 3 days of treatment. There are norestrictions on the use of immunotherapy during treatment. TKIs known to beradiation sensitizers such as BRAF should be held at least 24 hours prior totreatment.
Inability to have MRI imaging
Pregnancy
Treatment with another investigational drug 14 days of enrollment
Radiosurgery planned for post-operative adjuvant cavity only. Patients with anygross residual after surgery are eligible. Patients with at least one intactmetastasis may enroll but adjuvant cavity will not be evaluable.
At the time of Radiation Oncology consultation more than twenty targets areidentified. Note that it is common that a few additional metastases may beidentified during the treatment planning or peer review processes. More than twentytargets may be included if this number is found after the initial clinical review ofthe treatment planning MRI.
Tumor maximal diameter > 4 cm.
Prior SBRT or SRS to a lesion planned for retreatment. Note that patients with priorwhole brain radiation alone are eligible.
Patients with diffuse leptomeningeal tumor are not eligible. Patients with a focaldural or pachymeningeal tumor are eligible if other intra-axial tumors are plannedto be treated. Similar to postoperative cavities, the pachymeningeal tumor depositwill be treated but not evaluable for the assessment of local control or toxicity.
INCLUSION OF VULNERABLE PARTICIPANTS Vulnerable populations as defined by the NIH including children, prisoners, and adult subjects who lack capacity to consent to research participation are not eligible.
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham (UAB) Hazelrig-Salter Radiation Oncology Center
Birmingham, Alabama 35249
United StatesActive - Recruiting
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