Intrago II V2.4

• Research type

  Research Study

• Full title

  A multicenter randomized phase III trial on Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme (INTRAGO-II)

• IRAS ID

  246455

• Contact name

  Keyoumars Ashkan

• Contact email

  k.ashkan@nhs.net

• Sponsor organisation

  Department of Radiation Oncology, University Medical Center Mannheim

• Clinicaltrials.gov Identifier

  NCT02685605

• Clinicaltrials.gov Identifier

  ARO-2016-1 , Working Party for Radiation Oncology (ARO) of the German Cancer Society (DKG)

• Duration of Study in the UK

  3 years, 10 months, 30 days

• Research summary

  INTRAGO II is a multicentric, prospective, randomized, 2-arm, open-label clinical phase III trial which tests if the median progression-free survival (PFS) of patients with newly diagnosed glioblastoma multiforme (GBM) can be improved by the addition of intraoperative radiotherapy (IORT) to standard radiochemotherapy.

  Indication: Glioblastoma Multiforme (WHO Grade IV)
  Procedure: Standard surgery (neuronavigation-guided)
  Radiation: Intraoperative radiotherapy
  Radiation: Radiochemotherapy
  Drug: Temozolomide

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  18/LO/2145

• Date of REC Opinion

  20 Dec 2018

• REC opinion

  Favourable Opinion