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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

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Phase
Not applicable
Study type
Interventional
Enrollment
125
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

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.

02

Conditions studied

  • Brain Metastases

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03

In context

Brain Neoplasms

2,441 studies on the registry are indexed under Brain Neoplasms; 541 are open to participants now.

This study's planned enrollment of 125 is above the median of 40 across 1,832 interventional studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

John L. Villano, MD, PhD is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must have a radiographic suspected or confirmed with 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- regarding CNS (i.e., brain metastases) disease involvement, but this should be documented at baseline
  • performance status =3
  • of greater than 2 months
  • Ability to understand and the willingness to sign a written 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
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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.

06

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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2029, 36 months later.

Of 306 non-industry interventional studies with no phase under Brain Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 125. This study's planned 36 months is below that.

Counting every sponsor, half of 317 studies reached it within 64 months; a quarter within 35 and three quarters within 125.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 21, 2026
First posted
Aug 25, 2026
StartEst.
Sep 2026
Primary completionEst.
Sep 2029
CompletionEst.
Mar 2030
Last update
Aug 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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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Discussion

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