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Not yet recruitingNCT07786311Updated Aug 25, 2026

University of Kentucky Markey Cancer Center Neuro-Oncology Multi-Disciplinary Tumor Board Protocol for the Treatment of Advanced Brain Metastases

An interventional study of Neuro-Oncology Multi-Disciplinary Tumor Board Review in Brain Metastases, sponsored by John L. Villano, MD, PhD. Not yet recruiting. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by John L. Villano, MD, PhD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
125
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
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Study summary

This study evaluates whether review by the University of Kentucky Markey Cancer Center Neuro-Oncology Multidisciplinary Tumor Board improves clinical outcomes for adults with advanced brain metastases. Participants receive standard-of-care treatment as determined by their treating physicians. The study assesses whether multidisciplinary tumor board review and implementation of its treatment recommendations are associated with improved overall survival, progression-free survival, treatment selection and other clinical outcomes compared with patients who do not adhere to the tumor board recommendations.

Read the detailed description

Brain metastases are a common complication of advanced cancer and are associated with substantial morbidity and mortality. Management is complex and often requires coordination among multiple specialties including medical oncology, radiation oncology, neurosurgery, neuroradiology, neuropathology, pharmacy, and supportive care. Despite advances in systemic therapies and radiation techniques, optimal treatment selection remains challenging, particularly because the biology of brain metastases may differ from that of the primary tumor.

This study evaluates the impact of the University of Kentucky Markey Cancer Center Neuro-Oncology Multidisciplinary Tumor Board on the management of adults with suspected or confirmed brain metastases. Eligible participants are presented to the multidisciplinary tumor board, where specialists review clinical, imaging, pathology, and molecular information, when available, to develop individualized treatment recommendations. Treating physicians determine the final treatment approach and implementation of the tumor board recommendation is documented.

Participants receive standard-of-care therapies as clinically indicated, which may include surgery, stereotactic radiosurgery, whole-brain radiation therapy, systemic therapy, immunotherapy, targeted therapy, or supportive care. No investigational treatment is assigned as part of this protocol. Clinical outcomes, including overall survival, progression-free survival, treatment patterns, time to treatment initiation, and adherence to multidisciplinary recommendations are collected and analyzed. The study also seeks to determine whether multidisciplinary review is associated with improved patient outcomes and more coordinated care for individuals with advanced brain metastases.

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Conditions studied

  • Brain Metastases

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03

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients must have a radiographic suspected or histologically confirmed malignancy with brain metastases involvement and be recommended to undergo review or already undergone review for treatment recommendation(s) by the MCC NO-MD TB. NOTE: Patient may be enrolled up to 4 weeks before Neuro-Oncology Tumor Board. Five disease cohorts are: GI, breast, renal, NSCLC and melanoma.
  • Patients may have either measurable or non-measurable disease regarding CNS (i.e., brain metastases) disease involvement, but this should be documented at baseline
  • ECOG performance status =3
  • Life expectancy of greater than 2 months
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

Exclusion Criteria:

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
125 participants (estimated)

Study arms

  • Experimental
    Neuro-Oncology Multi-Disciplinary Tumor Board Review

    Participants with brain metastases undergo review by the Markey Cancer Center Neuro-Oncology Multi-Disciplinary Tumor Board. Treatment recommendations may include surgery, radiation therapy, systemic therapy, observation, or referral to additional clinical trials. Outcomes including adherence to recommendations and overall survival will be assessed.

    Other: Neuro-Oncology Multi-Disciplinary Tumor Board Review

Interventions

  • OtherNeuro-Oncology Multi-Disciplinary Tumor Board Review

    Participants with brain metastases undergo review by the Markey Cancer Center Neuro-Oncology Multi-Disciplinary Tumor Board. Treatment recommendations may include surgery, radiation therapy, systemic therapy, observation, or referral to additional clinical trials. Outcomes including adherence to recommendations and overall survival will be assessed.

05

What researchers measure

Primary outcomes

  1. Adherence to Neuro-Oncology Multi-Disciplinary Tumor Board Treatment Recommendations

    Proportion of participants who follow treatment recommendations made by the Neuro-Oncology Multi-Disciplinary Tumor Board.

    Time frame: Up to 3 years

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Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07786311
Lead sponsor
John L. Villano, MD, PhD
Responsible party
John L. Villano, MD, PhD (Principal Investigator, University of Kentucky) — Sponsor-investigator
First posted
Aug 25, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2029 (estimated)
Completion
Mar 2030 (estimated)
Last update
Aug 25, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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