
==== Front
Neurooncol Adv
Neurooncol Adv
noa
Neuro-Oncology Advances
2632-2498
Oxford University Press US

10.1093/noajnl/vdae090.089
vdae090.089
Final Category: Ongoing Clinical Trials
AcademicSubjects/MED00300
AcademicSubjects/MED00310
OCTS-04 TRIAL IN PROGRESS: PHASE II STUDY OF PRE-OPERATIVE HYPOFRACTIONATED STEREOTACTIC RADIOSURGERY FOR RESECTABLE BRAIN METASTASES
Oliver Daniel H. Lee Moffitt Cancer Center, Tampa/FL, USA

Tran Nam H. Lee Moffitt Cancer Center, Tampa/FL, USA

Ahmed Kamran H. Lee Moffitt Cancer Center, Tampa/FL, USA

DeJesus Michelle H. Lee Moffitt Cancer Center, Tampa/FL, USA

Liu James H. Lee Moffitt Cancer Center, Tampa/FL, USA

Furlan Andre Beer H. Lee Moffitt Cancer Center, Tampa/FL, USA

Kim Jongphil H. Lee Moffitt Cancer Center, Tampa/FL, USA

Farinhas Joaquim H. Lee Moffitt Cancer Center, Tampa/FL, USA

Vogelbaum Michael H. Lee Moffitt Cancer Center, Tampa/FL, USA

Booth-Jones Margaret H. Lee Moffitt Cancer Center, Tampa/FL, USA

Etame Arnold H. Lee Moffitt Cancer Center, Tampa/FL, USA

Yu Michael H. Lee Moffitt Cancer Center, Tampa/FL, USA

8 2024
02 8 2024
02 8 2024
6 Suppl 1 2024 SNO/ASCO CNS Metastases Conference i27i27
© The Author(s) 2024. Published by Oxford University Press, the Society for Neuro-Oncology and the European Association of Neuro-Oncology.
2024
https://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

Abstract

BACKGROUND

The current standard of care for limited resectable brain metastases is surgical resection followed by post-operative single-fraction stereotactic radiosurgery (sfSRS) to the resection cavity. Recent retrospective studies showed that pre-operative SRS improves tumor bed control and nodular leptomeningeal disease, but prospective data are lacking. We hypothesize that hypofractionated stereotactic radiosurgery (hfSRS) delivered pre-operatively to resectable brain metastases will result in improved durable local control.

METHODS

This is a single institution phase II study to assess time to local failure in patients with resectable brain metastases (BM) who elect for hfSRS followed by resection. The intervention is hfSRS delivered to a BM designated for resection. The planned target volume for hfSRS is the enhancing tumor + 1-2 mm margin expansion. The dose prescription is 9 Gy per fraction for a total of 3 consecutive daily fractions, to a total of 27 Gy. Surgical resection is planned within 7 days following completion of hfSRS. Other BMs, if present, are treated concurrently with either sfSRS or hfSRS. Key eligibility criteria include patients with at least 1 BM between 1 cm and 6 cm in maximal dimension not previously treated with SRS, deemed resectable by neurosurgery, and are asymptomatic from BM with or without steroids. The primary endpoint is time to local failure at the resection cavity. Other endpoints include time to leptomeningeal disease, changes in neurocognitive function, changes in quality of life (QoL), intracranial distant control, and overall survival. Time-to event outcomes will be analyzed with Kaplan-Meier curves. Changes in neurocognitive function and QoL metrics will be analyzed using descriptive statistics. This study is currently open with 34 patients enrolled at the time of submission. Clinical trial information: NCT05267587
==== Body
pmc
