Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme
NCT ID: NCT02685605
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
314 participants
INTERVENTIONAL
2016-12-09
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Arm (A)
Standard surgery plus intraoperative radiotherapy (20-30 Gy) followed by radiochemotherapy (EBRT: 60 Gy, 75 mg/m2/d temozolomide) and adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
Standard surgery
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).
Control Arm (B)
Standard surgery followed by radiochemotherapy (EBRT: 60 Gy, 75 mg/m2/d temozolomide) and adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
Standard surgery
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).
Interventions
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Standard surgery
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
8. IORT must be technically feasible
9. Histology supports diagnosis of GBM
Exclusion Criteria
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
10. Active egress of fluids from a ventricular defect
11. In-field risk organs and/or IORT dose \>8 Gy to any risk organ
18 Years
80 Years
ALL
No
Sponsors
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Carl Zeiss Meditec AG
INDUSTRY
University of California, Los Angeles
OTHER
Universitätsmedizin Mannheim
OTHER
Responsible Party
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Frank A. Giordano
PI (Chair)
Principal Investigators
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Frank A. Giordano, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, Germany
Kevin Petrecca, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurosurgery, Montréal Neurological, Institute and Hospital, Montréal, Canada
Locations
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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
Countries
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References
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Giordano FA, Brehmer S, Abo-Madyan Y, Welzel G, Sperk E, Keller A, Schneider F, Clausen S, Herskind C, Schmiedek P, Wenz F. INTRAGO: intraoperative radiotherapy in glioblastoma multiforme-a phase I/II dose escalation study. BMC Cancer. 2014 Dec 22;14:992. doi: 10.1186/1471-2407-14-992.
Sarria GR, Sperk E, Han X, Sarria GJ, Wenz F, Brehmer S, Fu B, Min S, Zhang H, Qin S, Qiu X, Hanggi D, Abo-Madyan Y, Martinez D, Cabrera C, Giordano FA. Intraoperative radiotherapy for glioblastoma: an international pooled analysis. Radiother Oncol. 2020 Jan;142:162-167. doi: 10.1016/j.radonc.2019.09.023. Epub 2019 Oct 16.
Ayala Alvarez DS, Watson PGF, Popovic M, Heng VJ, Evans MDC, Panet-Raymond V, Seuntjens J. Evaluation of Dosimetry Formalisms in Intraoperative Radiation Therapy of Glioblastoma. Int J Radiat Oncol Biol Phys. 2023 Nov 1;117(3):763-773. doi: 10.1016/j.ijrobp.2023.04.031. Epub 2023 May 5.
Cifarelli CP, Jacobson GM. Intraoperative Radiotherapy in Brain Malignancies: Indications and Outcomes in Primary and Metastatic Brain Tumors. Front Oncol. 2021 Nov 11;11:768168. doi: 10.3389/fonc.2021.768168. eCollection 2021.
Sarria GR, Smalec Z, Muedder T, Holz JA, Scafa D, Koch D, Garbe S, Schneider M, Hamed M, Vatter H, Herrlinger U, Giordano FA, Schmeel LC. Dosimetric Comparison of Upfront Boosting With Stereotactic Radiosurgery Versus Intraoperative Radiotherapy for Glioblastoma. Front Oncol. 2021 Oct 28;11:759873. doi: 10.3389/fonc.2021.759873. eCollection 2021.
Giordano FA, Brehmer S, Murle B, Welzel G, Sperk E, Keller A, Abo-Madyan Y, Scherzinger E, Clausen S, Schneider F, Herskind C, Glas M, Seiz-Rosenhagen M, Groden C, Hanggi D, Schmiedek P, Emami B, Souhami L, Petrecca K, Wenz F. Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma (INTRAGO): An Open-Label, Dose-Escalation Phase I/II Trial. Neurosurgery. 2019 Jan 1;84(1):41-49. doi: 10.1093/neuros/nyy018.
Other Identifiers
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ARO-2016-1
Identifier Type: OTHER
Identifier Source: secondary_id
AG-NRO-03
Identifier Type: OTHER
Identifier Source: secondary_id
INTRAGO-II
Identifier Type: -
Identifier Source: org_study_id
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