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Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme

NCT02685605 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2025-10-14

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • Frank A. Giordano, MD · Department of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, Germany

  • Kevin Petrecca, MD · Department of Neurosurgery, Montréal Neurological, Institute and Hospital, Montréal, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-09
Primary Completion
2025-11-30
Completion
2026-06-30

Countries

  • United States
  • Brazil
  • Canada
  • China
  • Germany
  • South Korea
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02685605 on ClinicalTrials.gov