Intraoperative Radiation Therapy in Newly Diagnosed Glioblastoma Multiforme

Official Title

A Multicentre Randomized Phase III Trial on INTraoperative RAdiotherapy in Newly Diagnosed GliOblastoma Multiforme (INTRAGO II)

Summary:

INTRAGO II resembles 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 radiation therapy (IORT) to standard radiochemotherapy.

Trial Description

Primary Outcome:

• Median Progression-Free Survival

• Median Overall Survival
• PFS within a 1-2 cm margin around the cavity
• OS with respect to Age
• PFS with respect to Age
• OS with respect to KPS
• PFS with respect to KPS
• OS with respect to thickness of anticipated T1-Gd-enhancing (remaining) tumour margin
• PFS with respect to thickness of anticipated T1-Gd-enhancing (remaining) tumour margin
• OS with respect to extent of resection
• PFS with respect to extent of resection
• OS with respect to MGMT promoter methylation status
• PFS with respect to MGMT promoter methylation status
• Quality of Life (QoL) questionnaire
• Activities of daily living (ADL), assessed using the Barthel Index (Mahoney & Barthel, 1965).
• Radiation-related (acute / early delayed / late) neurotoxicity

View this trial on ClinicalTrials.gov