Comparing Single vs Multiple Dose Radiation for Cancer Patients With Brain Metastasis and Receiving Immunotherapy (NCT05703269)

🧪 Interventions in This Study

• single fraction stereotactic radiosurgery (SSRS) (RADIATION)
• fractionated stereotactic radiosurgery (FSRS) (RADIATION)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. At least one intact brain metastasis or resection cavity ≥ 2 cm in diameter or ≥ 4 cc volume.
2. Patients at initial diagnosis of brain metastases and patients with known brain metastasis treated with systemic therapy alone are eligible.
3. Patients who have previously undergone SRS for brain metastases are eligible if all MRIs and DICOM-RT files from prior SRS courses are available for upload to TRIAD and there are no lesions requiring re-irradiation. Prior SRS data upload is NOT required prior to enrollment and randomization. Both SSRS and FSRS are acceptable.
4. Lesion volume will be approximated by measuring the lesion's three perpendicular diameters on contrast-enhanced, T1-weighted MRI and the product of those diameters will be divided by 2 to estimate the lesion volume (e.g., xyz/2). Alternatively, direct volumetric measurements via slice-by-slice contouring on a treatment planning software package can be used to calculate the total tumor volume.
5. Any extent of non-CNS disease is allowed. There is no requirement for non-CNS disease to be controlled prior to study entry.
6. For patients considered to be borderline or potentially eligible by size or volume criteria, sites have the option to send in DICOM films for central review screening.
7. Age ≥ 18 years at the time of enrollment.
8. Total number of brain metastases (including resection cavities) ≤ 15 on diagnostic MRI; all lesions must be amenable to SSRS and FSRS as determined by the treating radiation oncologist. Treatment must take place at a facility credentialed by the Imaging and Radiation Oncology Core (IROC) for SRS and that offers both SSRS and FSRS as treatment options.
9. Total gross tumor volume must be ≤ 30 cc. Lesion volume will be approximated by measuring each lesion's three perpendicular diameters on contrast-enhanced T1 MRI and the product of those diameters will be divided by 2 (V = xyz/2). Direct volumetric measurements by contouring all lesions on all visible slices on treatment planning software is also acceptable. If there is a cavity, only gross residual disease within or adjacent to the cavity is counted toward the 30 cc total volume.
10. Ability to tolerate MRI brain with gadolinium-based contrast.
11. Pathologically confirmed melanoma, renal cell carcinoma, non-small cell lung cancer, small cell lung cancer, or breast cancer.
12. Has received, is currently receiving, or is planned to receive immune checkpoint inhibitor therapy (defined as agent targeted to PD-1/PD-L1 axis) within 30 days of the planned first day of SSRS/FSRS. Dual ICI therapy with PD-1/PD-L1 and CTLA-4 targeted agents are allowed, but patients treated with a single agent CTLA-4 targeted agent only are ineligible. o It is not mandatory to wait for the results of next generation sequencing (NGS) or other molecular tumor testing to determine if the patient is planned to receive ICI if the enrolling physician feels that identification of a mutation that would preclude ICI therapy (such as an EGFR mutation in a patient with NSCLC) is unlikely to be identified.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (34 Sites)

Showing the first 25 of 34 sites.

• Lewis Cancer and Research Pavilion at Saint Joseph's/Candler — Savannah, Georgia
• Decatur Memorial Hospital — Decatur, Illinois
• Crossroads Cancer Center — Effingham, Illinois
• HSHS Saint Elizabeth's Hospital — O'Fallon, Illinois
• OSF Saint Francis Medical Center — Peoria, Illinois
• Trinity Health Saint Joseph Mercy Hospital Ann Arbor — Ann Arbor, Michigan
• Trinity Health IHA Medical Group Hematology Oncology - Brighton — Brighton, Michigan
• Genesys Hurley Cancer Institute — Flint, Michigan
• Trinity Health Saint Mary Mercy Livonia Hospital — Livonia, Michigan
• Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus — Ypsilanti, Michigan
• Mercy Hospital Springfield — Springfield, Missouri
• Mercy Hospital South — St Louis, Missouri
• Lovelace Medical Center-Saint Joseph Square — Albuquerque, New Mexico
• Lovelace Radiation Oncology — Albuquerque, New Mexico
• Carolinas Medical Center/Levine Cancer Institute — Charlotte, North Carolina
• Atrium Health Cabarrus/LCI-Concord — Concord, North Carolina
• Wake Forest University Health Sciences — Winston-Salem, North Carolina
• Sanford Broadway Medical Center — Fargo, North Dakota
• Sanford Roger Maris Cancer Center — Fargo, North Dakota
• Mercy Health - Perrysburg Hospital — Perrysburg, Ohio
• Saint Joseph's/Candler - Bluffton Campus — Bluffton, South Carolina
• Saint Francis Hospital — Greenville, South Carolina
• Prisma Health Cancer Institute - Faris — Greenville, South Carolina
• Saint Francis Cancer Center — Greenville, South Carolina
• Gibbs Cancer Center-Pelham — Greer, South Carolina

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.