Efficacy of pre-operative stereotactic radiosurgery followed by surgical resection and correlative radiobiological analysis for patients with 1-4 brain metastases

Study protocol for a phase II trial

Wei X. Huff, Namita Agrawal, Scott Shapiro, James Miller, Charles Kulwin, Mitesh Shah, Jesse J. Savage, Troy Payner, Alexander Vortmeyer, Gordon Watson, Mahua Dey

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background: Stereotactic radiosurgery (SRS) has emerged as a common adjuvant modality used with surgery for resectable brain metastases (BMs). However, the optimal sequence of the multi-modality therapy has not been established. The goal of the study is to evaluate 6-month local control utilizing pre-operative SRS followed by surgical resection for patients with 1-4 brain metastases. Methods: This prospective, single arm, phase II trial will recruit patients with up to 4 brain metastases and at least one resectable lesion. All lesions will be treated with SRS and symptomatic lesions will be resected within 1-4 days after SRS. Patients will be monitored for 6-month local control, in-brain progression free survival, distant in-brain failure, rate of leptomeningeal spread, radiation necrosis and overall survival. Additionally, we will also perform correlative radiobiological molecular studies to assess the effect of radiation dosing on the tumor tissue and clinical outcomes. We expect that pre-operative SRS to the gross tumor prior to surgical resection will improve local control and decrease leptomeningeal failure. Discussion: Our study is the second prospective trial to investigate the efficacy of pre-operative SRS in the treatment of multiple BMs. In addition, the correlative molecular studies will be the first to investigate early response of BMs at a cellular and genetic level in response to radiation doses and potentially provide molecular prognostic markers for local control and overall survival. Trial registration: Clinicaltrials.gov identifier: NCT03398694 (registration date: January 12, 2018).

Original languageEnglish (US)
Article number252
JournalRadiation Oncology
Volume13
Issue number1
DOIs
StatePublished - Dec 20 2018

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Radiosurgery
Neoplasm Metastasis
Brain
Radiation
Survival
Radiation Effects
Disease-Free Survival
Neoplasms
Necrosis
Therapeutics

Keywords

  • Brain metastases
  • Immune profiling
  • Metastases surgery
  • Molecular profiling
  • Stereotactic radiosurgery

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging

Cite this

Efficacy of pre-operative stereotactic radiosurgery followed by surgical resection and correlative radiobiological analysis for patients with 1-4 brain metastases : Study protocol for a phase II trial. / Huff, Wei X.; Agrawal, Namita; Shapiro, Scott; Miller, James; Kulwin, Charles; Shah, Mitesh; Savage, Jesse J.; Payner, Troy; Vortmeyer, Alexander; Watson, Gordon; Dey, Mahua.

In: Radiation Oncology, Vol. 13, No. 1, 252, 20.12.2018.

Research output: Contribution to journalArticle

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abstract = "Background: Stereotactic radiosurgery (SRS) has emerged as a common adjuvant modality used with surgery for resectable brain metastases (BMs). However, the optimal sequence of the multi-modality therapy has not been established. The goal of the study is to evaluate 6-month local control utilizing pre-operative SRS followed by surgical resection for patients with 1-4 brain metastases. Methods: This prospective, single arm, phase II trial will recruit patients with up to 4 brain metastases and at least one resectable lesion. All lesions will be treated with SRS and symptomatic lesions will be resected within 1-4 days after SRS. Patients will be monitored for 6-month local control, in-brain progression free survival, distant in-brain failure, rate of leptomeningeal spread, radiation necrosis and overall survival. Additionally, we will also perform correlative radiobiological molecular studies to assess the effect of radiation dosing on the tumor tissue and clinical outcomes. We expect that pre-operative SRS to the gross tumor prior to surgical resection will improve local control and decrease leptomeningeal failure. Discussion: Our study is the second prospective trial to investigate the efficacy of pre-operative SRS in the treatment of multiple BMs. In addition, the correlative molecular studies will be the first to investigate early response of BMs at a cellular and genetic level in response to radiation doses and potentially provide molecular prognostic markers for local control and overall survival. Trial registration: Clinicaltrials.gov identifier: NCT03398694 (registration date: January 12, 2018).",
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T2 - Study protocol for a phase II trial

AU - Huff, Wei X.

AU - Agrawal, Namita

AU - Shapiro, Scott

AU - Miller, James

AU - Kulwin, Charles

AU - Shah, Mitesh

AU - Savage, Jesse J.

AU - Payner, Troy

AU - Vortmeyer, Alexander

AU - Watson, Gordon

AU - Dey, Mahua

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