University of Kentucky Markey Cancer Center Neuro-Oncology Multi-Disciplinary Tumor Board Protocol for the Treatment of Advanced Brain Metastases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 125
- Primary Endpoint
- Adherence to Neuro-Oncology Multi-Disciplinary Tumor Board Treatment Recommendations
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- 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
- •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
Arms & Interventions
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.
Intervention: Neuro-Oncology Multi-Disciplinary Tumor Board Review (Other)
Outcomes
Primary Outcomes
Adherence to Neuro-Oncology Multi-Disciplinary Tumor Board Treatment Recommendations
Time Frame: Up to 3 years
Proportion of participants who follow treatment recommendations made by the Neuro-Oncology Multi-Disciplinary Tumor Board.
Secondary Outcomes
No secondary outcomes reported
Investigators
John L. Villano, MD, PhD
Principal Investigator
University of Kentucky