NCT04047602

Radiosurgery Dose Reduction for Brain Metastases on Immunotherapy (RADREMI): A Prospective Pilot Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a prospective, single arm, pilot study to determine the symptomatic radiation necrosis rate at 6 months utilizing dose-reduced stereotactic radiosurgery with immunotherapy for subjects with a diagnosis of 1-10 brain metastases from MRI and tissue diagnosis of primary malignancy. Primary end-point is 6 month symptomatic radiation necrosis, defined as a 6-month rate of clinical symptomatology requiring steroid administration (i.e. Decadron) and/or operative intervention concomitant with advanced and routine brain imaging findings consistent with radiation necrosis. Follow-up MRIs will be fused with the planning scan for this assessment.

Conditions

• Brain Tumor
• Brain Metastases
• Brain Cancer

Interventions

Type	Name	Description
RADIATION	Reduced Dose SRS	Subjects will receive SRS treatment at a reduced dose based on the brain tumor size

Timeline

• Start date: 2019-12-12
• Primary completion: 2023-07-25
• Completion: 2024-02-20
• First posted: 2019-08-07
• Last updated: 2025-02-13
• Results posted: 2024-09-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study