Protocol digest of a phase III randomized trial of gross total resection versus possible resection of fluid-attenuated inversion recovery-hyperintense lesion on MRI for newly diagnosed supratentorial glioblastoma: JCOG2209 (FLAMINGO)

Jpn J Clin Oncol. 2025 Jan 8;55(1):75-79. doi: 10.1093/jjco/hyae130.

Abstract

The goal of surgery for patients with newly diagnosed glioblastoma (GBM) is maximum safe resection of the contrast-enhancing (CE) lesion on magnetic resonance imaging. However, there is no consensus on the efficacy of FLAIRectomy, which is defined as the possible resection of fluid-attenuated inversion recovery (FLAIR)-hyperintense lesions surrounding the CE lesion. Although retrospective analyses suggested the potential benefits of FLAIRectomy, such outcomes have not been confirmed by prospective studies. Therefore, we planned a multicenter, open-label, randomized controlled phase III trial to evaluate the efficacy of FLAIRectomy compared with gross total resection of CE lesions in patients with newly diagnosed GBM. The primary endpoint is overall survival. In total, 130 patients will be enrolled from 47 institutions over 5 years. This trial has been registered at the Japan Registry of Clinical Trials (study number jRCT1031230245).

Keywords: FLAIRectomy; glioblastoma; gross tumor resection; supratotal resection.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Clinical Trial Protocol

MeSH terms

  • Adult
  • Aged
  • Brain Neoplasms / diagnostic imaging
  • Brain Neoplasms / pathology
  • Brain Neoplasms / surgery
  • Clinical Trials, Phase III as Topic
  • Female
  • Glioblastoma* / diagnostic imaging
  • Glioblastoma* / pathology
  • Glioblastoma* / surgery
  • Humans
  • Japan
  • Magnetic Resonance Imaging* / methods
  • Male
  • Middle Aged
  • Randomized Controlled Trials as Topic
  • Supratentorial Neoplasms / diagnostic imaging
  • Supratentorial Neoplasms / pathology
  • Supratentorial Neoplasms / surgery