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NCT06974370 · ClinicalTrials.gov registry record · Phase 2
Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and/or Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial
A Phase 2 study, sponsored by University of Vermont Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT06974370 is a Phase 2 study that is actively recruiting participants, run by University of Vermont Medical Center. The registered enrollment target is 45 participants.
The verdict
NCT06974370, a Phase 2 study, is actively recruiting participants, sponsored by University of Vermont Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
This pilot pragmatic trial evaluates the feasibility of avoiding radiation therapy in patients with brain metastases who demonstrate an intracranial response to systemic therapy-including immunotherapy, targeted therapy, and/or chemotherapy. The study will prospectively enroll 45 patients, divided into two cohorts: 30 with non-small cell lung cancer (NSCLC) receiving immunotherapy, and 15 with brain metastases from other solid tumors. Eligible participants must have at least one brain metastasis not planned for radiation or surgery and must be initiating or planning to initiate a systemic therapy regimen expected to penetrate the blood-brain barrier and achieve intracranial activity. All patients will undergo a re-evaluation brain MRI 4-8 weeks after initiating systemic therapy. If lesions are stable or regressing, patients will continue surveillance without radiation. If progression is noted, standard-of-care radiation may be administered at the discretion of the treating physician. The primary objective is to assess 6-month radiation therapy-free survival (RTFS) in NSCLC patients based on PD-L1 expression status. Secondary endpoints include intracranial progression-free survival, overall survival, radiation necrosis rate, and quality of life. This study seeks to inform future trial design and identify patients who may safely avoid brain radiation.
Interventions
- RADIATION Active Surveillance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2025-06-05 |
| Est. Completion | 2030-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06974370
The ClinicalTrials.gov registry entry for NCT06974370 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Vermont Medical Center, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Active Surveillance is the first listed.
NCT06974370 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06974370 about?
NCT06974370 is a clinical study titled "Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and/or Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial". This pilot pragmatic trial evaluates the feasibility of avoiding radiation therapy in patients with brain metastases who demonstrate an intracranial response to systemic therapy-including immunotherapy, targeted therapy, and/or chemotherapy. The study will prospectively enroll 45 patients, divided i...
What is the current status of trial NCT06974370?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2025-06-05. Estimated completion is 2030-12.
What interventions are being tested in trial NCT06974370?
The interventions under investigation include: Active Surveillance (RADIATION).
Who is sponsoring clinical trial NCT06974370?
This trial is sponsored by University of Vermont Medical Center, which has 27 total clinical trials registered on ClinicalTrials.gov.
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