Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-25 @ 3:49 AM
NCT ID:
NCT04047602
Eligibility Criteria:
Inclusion Criteria:
1. Brain MRI-confirmed 1-10 solid tumor brain metastases
2. Biopsy-confirmed primary malignancy
3. ds-GPA estimated median survival of at least 6 months, for histologies not included in the ds-GPA, publications or noted online at brainmetgpa.com, the PI will use either published or validated data or their best clinical judgment to determine the patient's expected survival
4. Stereotactic radiosurgery candidate per treating Radiation Oncologist
5. ≥ 18 years old at the time of informed consent
6. Ability to provide written informed consent and HIPAA (Health Insurance Portability and Accountability Act) authorization.
7. ALC \> 800/ul (Ku et al., 2010)
8. Patients currently on cytotoxic chemotherapy are eligible
9. Patients receiving ICI up to 30 days prior to delivery of SRS are eligible
10. Patients having undergone operative resection for metastatic brain disease within 30 days of immune checkpoint inhibitor (ICI) administration are eligible.
Exclusion Criteria:
1. Major medical illnesses or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up
2. Patients unable to receive MRI Brain
3. Patients with more than 10 brain metastases on MRI Brain imaging
4. Any lesion \> 4 centimeter maximum diameter
5. Total volume of metastatic disease more than 30 cubic centimeters
6. Previous whole brain radiation therapy
7. For Cohort 1: Previous stereotactic radiosurgery where the 50% isodose line overlaps with current treatment field
8. For Cohort 2: Patients whose treatment will have a dose overlap within the target from prior treatments of 20% or greater
9. Already receiving chronic dexamethasone (chronic = \> 2 weeks) prior to SRS
10. Not a radiosurgical candidate per Radiation Oncology discretion
11. Existing autoimmune disease
12. Patients who have an unknown primary cancer
13. Histology not amenable for SRS (i.e. lymphoma). (Small Cell Lung Cancer IS amenable.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04047602
Study Brief:
Protocol Section:
NCT04047602