Rmtc-10 Defining Symptomatic Versus Asymptomatic Brain Metastases for Clinical Trial Eligibility: a Delphi Consensus Initiative
Year: 2026
Type: article
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.
Source: Neuro-Oncology Advances
Authors: Katarzyna J Jerzak, Amanda E D Vanswearingen, Frances Chow, Mariza Daras, Faisal Fa’ak, David Kamson, Mustafa Khasraw, Lianne Kraemer, Sunil Krishnan, Emilie LeRhun, Stefania Maraka, Nelson Moss, Seema Nagpal, Joshua Palmer, Yolanda Pina, Solmaz Sahebjam, Soma Sengupta, Riccardo Soffietti, Carey K Anders, Hussein Tawbi
Institutions: Sunnybrook Health Science Centre, University of Toronto, Odette Cancer Centre, Duke University, University of Southern California, USC Norris Comprehensive Cancer Center, Virginia Commonwealth University, Johns Hopkins University, SHARE, The University of Texas Health Science Center at Houston, University of Zurich, Memorial Sloan Kettering Cancer Center, Stanford University, The Ohio State University, Moffitt Cancer Center, Tufts University, University of Turin, The University of Texas MD Anderson Cancer Center
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,615
OpenAlex ID: W7201847183
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