Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme

Running, not enrolling · Phase 3

Conditions studied: Glioblastoma

In brief

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.

Key facts

Study ID

NCT02685605

Run by

Universitätsmedizin Mannheim

People needed

314

Starts

2016-12-09

Expected to finish

2026-06-01

Last updated by the study team

2025-10-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 and ≤ 80 years
• Karnofsky Performance Score (KPS) ≥ 60%
• Supratentorial T1-Gd enhancing lesion(s) amenable to total resection
• Legal capacity and ability of subject to understand character and individual consequences of the clinical trial
• Patient's written IC obtained at least 24h prior to surgery
• For women with childbearing potential: adequate contraception
• Patients must have adequate organ functions
• Bone marrow function:
• Platelets ≥ 75.000/μL
• WBC ≥ 3.000/μL
• Hemoglobin ≥ 10.0 g/dL
• Liver Function:
• ASAT and ALAT ≤ 3.0 times ULN
• ALP ≤ 2.5 times ULN
• Total Serum Bilirubin < 1.5 times ULN
• Renal Function:
• Serum Creatinine ≤ 1.5 times ULN
• Inclusion Criteria Related to Surgery:
• IORT must be technically feasible
• Histology supports diagnosis of GBM

You may not qualify if…

• Multicentric disease (e.g. in both hemispheres) or non-resectable satellite lesions
• Previous cranial radiation therapy
• Cytostatic therapy / chemotherapy for cancer within the past 5 years
• History of cancers or other comorbidities that limit life expectancy to less than five years
• Previous therapy with anti-angiogenic substances (such as bevacizumab)
• Technical impossibility to use MRI or known allergies against MRI and/or CT contrast agents
• Participation in other clinical trials testing cancer-derived investigational agents/procedures.
• Pregnant or breast feeding patients
• Fertile patients refusing to use safe contraceptive methods during the study
• Exclusion Criteria Related to Surgery:
• Active egress of fluids from a ventricular defect
• In-field risk organs and/or IORT dose >8 Gy to any risk organ

Where it is running

• Barrow Neurological Institute (SJHMC) — Phoenix, Arizona, United States
• Stritch School of Medicine Loyola University — Maywood, Illinois, United States
• Long Island Jewish Medical Center, North Shore University Hospital — Lake Success, New York, United States
• Lenox Hill Hospital, Hofstra Northwell School of Medicine — New York, New York, United States
• West Virginia University — Morgantown, West Virginia, United States
• Hospital Alemão Oswaldo Cruz — São Paulo, Brazil
• Montreal Neurological Institute and Hospital — Montreal, Quebec, Canada
• Beijing Tian Tan Hospital, Capital Medical University — Beijing, China
• University Hospital Augsburg — Augsburg, Germany
• Charité - Universitätsmedizin — Berlin, Germany
• St. Georg Hospital — Leipzig, Germany
• University Hospital Mannheim — Mannheim, Germany
• Technical University of Munich (TUM), Department of Radiation Oncology — Munich, Germany
• Klinikum Stuttgart — Stuttgart, Germany
• Helios University Hospital Wuppertal — Wuppertal, Germany
• Gangnam Severance Hospital, Yonsei University College of Medicine — Seoul, South Korea
• Catalan Institute of Oncology (ICO) — Barcelona, Spain
• Hospital Reina Sofia — Córdoba, Spain
• The London Clinic — London, United Kingdom

Full record on ClinicalTrials.gov

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