Status:
NOT_YET_RECRUITING
Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and/or Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial
Lead Sponsor:
University of Vermont Medical Center
Conditions:
Brain Metastases, Adult
Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 immunotherap...
Detailed Description
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 immunotherap...
Eligibility Criteria
Inclusion
- Pathologically (histologically or cytologically) proven diagnosis of a solid tumor malignancies within 5 years prior to registration. If the original histologic proof of malignancy is greater than 5 years, then more recent pathologic confirmation (e.g., from a systemic site or brain metastasis) or unequivocal imaging confirmation of extracranial metastatic disease (e.g. CT of the chest/abdomen/pelvis, PET/CT, etc.) is required. These scans are considered standard-of-care (SOC) and will not be ordered for research purposes.
- Initiation or planning for initiation of systemic therapy to include one or more of the following categories expected to cause an intracranial response:
- Brain penetrant targeted therapies (e.g. tyrosine kinase inhibitors, multikinase inhibitors, EGFR inhibitor, ALK inhibitor, BRAF/MEK inhibitor)
- Checkpoint inhibitor immunotherapy (e.g. PDL-1 inhibitors, PD1 inhibitors, CTLA-4 inhibitors)
- HER2 antibody-drug conjugate (e.g. TDM1, TDX-D)
- Anti-Hormone therapies for Breast Cancer
- Cytotoxic chemotherapy alone may be started initially, but with plan for immunotherapy or eligible targeted therapy noted above before the re-evaluation MRI head
- At least 1 brain metastasis that not planned for radiation therapy or surgery.
- All brain metastases not planned for resection much be ≤3 cm, with no minimum size required.
- Systemic therapy has started within 4 weeks of MRI brain showing new or progressive disease or plan to start systemic therapy within 4 weeks of MRI brain showing new or progressive disease.
- Ability to obtain MRI head scans with contrast. All MRI head scans must have slice thickness ≤1.5 mm.
- Age ≥ 18 years
- KPS \>60
- Ability to understand and the willingness to sign a written informed consent.
Exclusion
- No use of the planned new systemic therapy meeting 2.1.2 criteria to address brain metastases within the last 6 months.
- Prior radiotherapy to the active brain metastases (partial or whole brain irradiation, or prophylactic cranial irradiation \[PCI\])
- Patients pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. Negative urine pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.
- Serious medical comorbidities that in the opinion of the investigator would prevent participation in this study.
- Known leptomeningeal disease (LMD)
- \-
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06974370
Start Date
December 1 2025
End Date
December 1 2030
Last Update
May 15 2025
Active Locations (1)
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1
University of Vermont Medical Center
Burlington, Vermont, United States, 05401