RMTC-10 DEFINING SYMPTOMATIC VERSUS ASYMPTOMATIC BRAIN METASTASES FOR CLINICAL TRIAL ELIGIBILITY: A DELPHI CONSENSUS INITIATIVE

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Abstract Background Brain metastases are common in patients with metastatic solid tumors, particularly among those with breast cancer, lung cancer and melanoma. Although clinical trials increasingly include patients with brain metastases, the presence of neurological symptoms and/or use of supportive medications to control symptoms (e.g. steroids, anti-seizure medications) remain common exclusion criteria, limiting generalizability of trial results. Methods In 2024, the Consortium for Intracranial Metastasis Academic Research (CIMARa) group convened a multi-disciplinary panel of expert clinicians to identify opportunities to expand clinical trial eligibility criteria for patients with solid tumors and brain metastases. The Working Group consisted of 18 members, including medical oncologists, radiation oncologists, neurosurgeons and neuro-oncologists. Through regular meetings, the panel examined nuances in the inclusion and exclusion of patients with brain metastases from clinical trials and developed strategies to safely increase enrollment of patients with symptomatic disease. Additional input, including from patient advocates, was obtained at the 2025 Society for Neuro-Oncology (SNO)/American Society of Clinical Oncology (ASCO) Brain Metastases “Think Tank” and a meeting of the National Cancer Institute’s Brain Metastases Interest Group. Results The working group developed 12 candidate consensus statements in the pre-Delphi preparation phase. Eighty-two voters, including the 18 working group members, agreed to participate in a Delphi process. Consensus is defined a priori as ≥ 75% agreement after up to 3 rounds of online voting. Round 1 is currently ongoing. Conclusion The initiative will generate consensus recommendations defining symptomatic versus asymptomatic brain metastases for clinical trial eligibility, informed by an international multidisciplinary group of clinicians, researchers, and advocates. The resulting language will provide guidance for investigators and sponsors when developing clinical trial eligibility criteria to broaden enrollment, improve consistency across studies, and inform selection of clinically relevant trial endpoints.

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