NCT02685605

Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: Universitätsmedizin Mannheim · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 radiotherapy (IORT) to standard radiochemotherapy.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
PROCEDURE	Standard surgery
RADIATION	Intraoperative radiotherapy	Dose to applicator surface: 20-30 Gy; Carl Zeiss INTRABEAM System. IORT with a surface dose of 30 Gy is recommended.Should the proximity to any risk structure not allow to apply 30 Gy, a dose reduction by up to 10 Gy (resulting in a surface dose of 20 Gy) is allowed.
RADIATION	Radiochemotherapy	EBRT to 60 Gy plus 75 mg/m2/d temozolomide
DRUG	Temozolomide	Adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).

Timeline

• Start date: 2016-12-09
• Primary completion: 2025-11-01
• Completion: 2026-06-01
• First posted: 2016-02-19
• Last updated: 2025-10-14

Locations

19 sites across 8 countries: United States, Brazil, Canada, China, Germany, South Korea, Spain, United Kingdom