Standard surgeryIntraoperative radiotherapyRadiochemotherapyTemozolomide
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.
Radiochemotherapy: EBRT to 60 Gy plus 75 mg/m2/d temozolomide
Temozolomide: Adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria
1. Age ≥18 and ≤ 80 years
2. Karnofsky Performance Score (KPS) ≥ 60%
3. Supratentorial T1-Gd enhancing lesion(s) amenable to total resection
4. Legal capacity and ability of subject to understand character and individual consequences of the clinical trial
5. Patient's written IC obtained at least 24h prior to surgery
6. For women with childbearing potential: adequate contraception
7. 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:
8. IORT must be technically feasible
9. Histology supports diagnosis of GBM
Exclusion Criteria
1. Multicentric disease (e.g. in both hemispheres) or non-resectable satellite lesions
2. Previous cranial radiation therapy
3. Cytostatic therapy / chemotherapy for cancer within the past 5 years
4. History of cancers or other comorbidities that limit life expectancy to less than five years
5. Previous therapy with anti-angiogenic substances (such as bevacizumab)
6. Technical impossibility to use MRI or known allergies against MRI and/or CT contrast agents
7. Participation in other clinical trials testing cancer-derived investigational agents/procedures.
8. Pregnant or breast feeding patients
9. Fertile patients refusing to use safe contraceptive methods during the study
Exclusion Criteria Related to Surgery:
10. Active egress of fluids from a ventricular defect
11. In-field risk organs and/or IORT dose \>8 Gy to any risk organ
Primary outcome measure(s)
Median Progression-Free Survival — 24 Months Determined according to modified Response Assessment in Neuro-Oncology (RANO) criteria and serial perfusion imaging
Trial sites (19)
Facility
City
Region
Status
Barrow Neurological Institute (SJHMC)
Phoenix
Arizona
Stritch School of Medicine Loyola University
Maywood
Illinois
Long Island Jewish Medical Center, North Shore University Hospital
Lake Success
New York
Lenox Hill Hospital, Hofstra Northwell School of Medicine
New York
New York
West Virginia University
Morgantown
West Virginia
Hospital Alemão Oswaldo Cruz
São Paulo
Brazil
Montreal Neurological Institute and Hospital
Montreal
Quebec
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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