Radiosurgery Dose Reduction for Brain Metastases on Immunotherapy (RADREMI): A Prospective Pilot Study
Stopped early · Not applicable
Conditions studied: Brain Tumor, Brain Metastases, Brain Cancer
In brief
This study will evaluate the rate of radiation necrosis following treatment with immune checkpoint inhibitor (ICI) treatment and radiation therapy in subjects with metastatic brain cancer. Subjects will be treated with the standard of care immunotherapy followed by radiation therapy via stereotactic radiosurgery at a reduced dose.
Key facts
- Study ID
- NCT04047602
- Run by
- Indiana University
- People needed
- 18
- Starts
- 2019-12-12
- Expected to finish
- 2024-02-20
- Last updated by the study team
- 2025-02-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Brain MRI-confirmed 1-10 solid tumor brain metastases
- Biopsy-confirmed primary malignancy
- 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
- Stereotactic radiosurgery candidate per treating Radiation Oncologist
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA (Health Insurance Portability and Accountability Act) authorization.
- ALC > 800/ul (Ku et al., 2010)
- Patients currently on cytotoxic chemotherapy are eligible
- Patients receiving ICI up to 30 days prior to delivery of SRS are eligible
- Patients having undergone operative resection for metastatic brain disease within 30 days of immune checkpoint inhibitor (ICI) administration are eligible.
You may not qualify if…
- 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
- Patients unable to receive MRI Brain
- Patients with more than 10 brain metastases on MRI Brain imaging
- Any lesion > 4 centimeter maximum diameter
- Total volume of metastatic disease more than 30 cubic centimeters
- Previous whole brain radiation therapy
- For Cohort 1: Previous stereotactic radiosurgery where the 50% isodose line overlaps with current treatment field
- For Cohort 2: Patients whose treatment will have a dose overlap within the target from prior treatments of 20% or greater
- Already receiving chronic dexamethasone (chronic = > 2 weeks) prior to SRS
- Not a radiosurgical candidate per Radiation Oncology discretion
- Existing autoimmune disease
- Patients who have an unknown primary cancer
- Histology not amenable for SRS (i.e. lymphoma). (Small Cell Lung Cancer IS amenable.)
Where it is running
- Indiana University Health Hospital — Indianapolis, Indiana, United States
- Indiana University Methodist Hospital — Indianapolis, Indiana, United States
- Oregon Health and Sciences — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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