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临床试验/NCT07786311
NCT07786311尚未招募不适用

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

John L. Villano, MD, PhD0 个研究点目标入组 125 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
125
主要终点
Adherence to Neuro-Oncology Multi-Disciplinary Tumor Board Treatment Recommendations

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Neuro-Oncology Multi-Disciplinary Tumor Board Review

Experimental

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.

干预措施: Neuro-Oncology Multi-Disciplinary Tumor Board Review (Other)

结局指标

主要结局

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

时间窗: Up to 3 years

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

次要结局

未报告次要终点

研究者

发起方
John L. Villano, MD, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

John L. Villano, MD, PhD

Principal Investigator

University of Kentucky

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