Preoperative stereotactic radiosurgery for patients with 1-4 brain metastases: A single-arm phase 2 trial outcome analysis (NCT03398694).

brain metastases phase II clinical trial stereotactic radiosurgery

Journal

Neuro-oncology practice
ISSN: 2054-2577
Titre abrégé: Neurooncol Pract
Pays: England
ID NLM: 101640528

Informations de publication

Date de publication:
Oct 2024
Historique:
pmc-release: 08 05 2025
medline: 16 9 2024
pubmed: 16 9 2024
entrez: 16 9 2024
Statut: epublish

Résumé

Stereotactic radiosurgery (SRS) following surgical resection is the standard of care for patients with symptomatic oligo brain metastasis (BM), however, it is associated with 10-15% local failure. Targeting a resection cavity is imprecise, thus preoperative radiosurgery where the target is well-defined may be superior, however, the efficacy of preoperative SRS has not yet been tested in a clinical trial. We conducted a phase 2, single-arm trial of preoperative SRS followed by surgical resection in patients with 1-4 symptomatic oligo BMs (NCT03398694) with the primary objective of measuring 6-month local control (LC). SRS was delivered to all patients utilizing a gamma knife or linear accelerator as per RTOG-9005 dosing criteria [Shaw E, Scott C, Souhami L, et al. Single dose radiosurgical treatment of recurrent previously irradiated primary brain tumors and brain metastases: final report of RTOG protocol 90-05. The trial screened 50 patients, 48 patients were treated under the protocol and 32 patients completed the entire follow-up period. Of all the patients who completed the follow-up period, the primary endpoint of 6-month LC was 100% (95% CI: 0.891-1.000; Our data confirms superior local control in patients who received preoperative SRS when compared to historical controls. Further study with a larger randomized cohort of patients is warranted to fully understand the benefits of preoperative SRS.

Sections du résumé

Background UNASSIGNED
Stereotactic radiosurgery (SRS) following surgical resection is the standard of care for patients with symptomatic oligo brain metastasis (BM), however, it is associated with 10-15% local failure. Targeting a resection cavity is imprecise, thus preoperative radiosurgery where the target is well-defined may be superior, however, the efficacy of preoperative SRS has not yet been tested in a clinical trial.
Methods UNASSIGNED
We conducted a phase 2, single-arm trial of preoperative SRS followed by surgical resection in patients with 1-4 symptomatic oligo BMs (NCT03398694) with the primary objective of measuring 6-month local control (LC). SRS was delivered to all patients utilizing a gamma knife or linear accelerator as per RTOG-9005 dosing criteria [Shaw E, Scott C, Souhami L, et al. Single dose radiosurgical treatment of recurrent previously irradiated primary brain tumors and brain metastases: final report of RTOG protocol 90-05.
Results UNASSIGNED
The trial screened 50 patients, 48 patients were treated under the protocol and 32 patients completed the entire follow-up period. Of all the patients who completed the follow-up period, the primary endpoint of 6-month LC was 100% (95% CI: 0.891-1.000;
Conclusions UNASSIGNED
Our data confirms superior local control in patients who received preoperative SRS when compared to historical controls. Further study with a larger randomized cohort of patients is warranted to fully understand the benefits of preoperative SRS.

Identifiants

pubmed: 39279766
doi: 10.1093/nop/npae043
pii: npae043
pmc: PMC11398945
doi:

Types de publication

Journal Article

Langues

eng

Pagination

593-603

Informations de copyright

© The Author(s) 2024. Published by Oxford University Press on behalf of the Society for Neuro-Oncology and the European Association of Neuro-Oncology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.

Déclaration de conflit d'intérêts

The authors declare no conflict of interest.

Auteurs

Namita Agrawal (N)

Department of Radiation Oncology, Indiana University School of Medicine, Indianapolis, Indianapolis, USA.

Jack M Shireman (JM)

Department of Neurosurgery, University of Wisconsin Madison School of Medicine and Public Health, Madison, Wisconsin, USA.

Kevin Shiue (K)

Department of Radiation Oncology, Indiana University School of Medicine, Indianapolis, Indianapolis, USA.

Aaron Kamer (A)

Department of Clinical Radiology and Imaging Sciences, Indiana University School of Medicine, Indianapolis, Indianapolis, USA.

LaKeisha Boyd (L)

Department of Biostatistics and Health Data Science, Indiana University School of Medicine and Richard M. Fairbanks School of Public Health, Indianapolis, Indianapolis, USA.

Yong Zang (Y)

Department of Biostatistics and Health Data Science, Indiana University School of Medicine and Richard M. Fairbanks School of Public Health, Indianapolis, Indianapolis, USA.

Neel Mukherjee (N)

Department of Neurosurgery, University of Wisconsin Madison School of Medicine and Public Health, Madison, Wisconsin, USA.

James Miller (J)

Department of Neurological Surgery, Indiana University School of Medicine, Indianapolis, Indianapolis, USA.

Charles Kulwin (C)

Goodman Campbell Brain and Spine Neurological Surgery, Indianapolis, Indianapolis, USA.

Aaron Cohen-Gadol (A)

Department of Neurological Surgery, Indiana University School of Medicine, Indianapolis, Indianapolis, USA.

Troy Payner (T)

Goodman Campbell Brain and Spine Neurological Surgery, Indianapolis, Indianapolis, USA.

Chih-Ta Lin (CT)

Department of Neurological Surgery, Indiana University School of Medicine, Indianapolis, Indianapolis, USA.

Jesse J Savage (JJ)

Department of Neurological Surgery, Indiana University School of Medicine, Indianapolis, Indianapolis, USA.

Brandon Lane (B)

Department of Neurological Surgery, Indiana University School of Medicine, Indianapolis, Indianapolis, USA.

Bradley Bohnstedt (B)

Department of Neurological Surgery, Indiana University School of Medicine, Indianapolis, Indianapolis, USA.

Tim Lautenschlaeger (T)

Department of Radiation Oncology, Indiana University School of Medicine, Indianapolis, Indianapolis, USA.

Naoyuki Saito (N)

Department of Radiation Oncology, Indiana University School of Medicine, Indianapolis, Indianapolis, USA.

Mitesh Shah (M)

Department of Neurological Surgery, Indiana University School of Medicine, Indianapolis, Indianapolis, USA.

Gordon Watson (G)

Department of Radiation Oncology, Indiana University School of Medicine, Indianapolis, Indianapolis, USA.

Mahua Dey (M)

Department of Neurosurgery, University of Wisconsin Madison School of Medicine and Public Health, Madison, Wisconsin, USA.

Classifications MeSH