Actively Recruiting
Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and/or Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial (ACTION-Brain Metastases: Pilot Pragmatic Trial)
Led by University of Vermont Medical Center · Updated on 2026-05-26
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the possibility of avoiding radiation therapy in patients with brain metastases who respond to systemic treatments like immunotherapy, targeted therapy, or chemotherapy. This pilot pragmatic trial focuses on 45 patients divided into two groups: 30 with non-small cell lung cancer (NSCLC) receiving immunotherapy, and 15 with brain metastases from other solid tumors. Eligible patients must have at least one brain metastasis not scheduled for radiation or surgery and be starting or planning to start systemic therapy expected to work within the brain. Participants will receive standard systemic therapy expected to reach the brain, such as immunotherapy or targeted agents. A brain MRI will be done 4 to 8 weeks after starting treatment to check the metastases. If the tumors are stable or shrinking, patients will continue on their systemic therapy with brain MRI scans every three months for up to two years. Radiation therapy will only be given if the tumors show progression, based on the treating physician's decision. This approach applies to all participants regardless of their primary cancer type. During the study, participants will undergo regular brain MRI scans and clinical assessments to monitor tumor response and neurological function. Researchers will track outcomes like radiation therapy-free survival at 6 months, intracranial progression, overall survival, radiation necrosis rates, and quality of life using specific questionnaires and scales. The study aims to collect information that will help design future trials and identify patients who might safely avoid brain radiation. The total follow-up for MRI surveillance can last up to two years.
CONDITIONS
Brief Title
Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and/or Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed diagnosis of solid tumor malignancy within 5 years or recent confirmation of metastatic disease
- Planning to start or have started systemic therapy expected to cause intracranial response, including brain-penetrant targeted therapies, checkpoint inhibitor immunotherapy, HER2 antibody-drug conjugates, anti-hormone therapies, or chemotherapy with planned immunotherapy or targeted therapy
- At least one brain metastasis not planned for radiation or surgery
- Brain metastases not planned for resection must be 3 cm or smaller
- Systemic therapy started within 4 weeks before or after MRI showing new or progressive brain disease
- Ability to obtain brain MRI with contrast and slice thickness of 1.5 mm or less
- Age 18 years or older
- Karnofsky Performance Status greater than 60
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- No use of planned systemic therapy to address brain metastases within last 6 months
- Prior radiotherapy to active brain metastases, including whole brain or prophylactic cranial irradiation
- Pregnant or nursing individuals; negative pregnancy test required for those of childbearing potential
- Serious medical conditions preventing study participation as judged by investigator
- Known leptomeningeal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 8 weeks
Participants start systemic therapy expected to have intracranial activity and undergo a re-evaluation brain MRI 4 to 8 weeks after starting therapy to assess the response of brain metastases.
1 visit for re-evaluation MRI
Duration - Up to 2 years
Participants with stable or responding brain metastases continue systemic therapy and undergo MRI surveillance every 3 months to monitor brain metastases. Radiation therapy is only given if disease progression is observed.
MRI visits every 3 months
Trial Site Locations
Total: 1 location
1
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
Research Team
C
Christopher Anker, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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