GlioblastomaPhase 3INTRAGO-IINCT02685605
Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme
A Phase 3 study testing Standard surgery, Intraoperative radiotherapy and Radiochemotherapy in people with Glioblastoma, run by Universitätsmedizin Mannheim at 19 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Standard surgery, Intraoperative radiotherapy and Radiochemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 19 sitesin 8 countries
- Study dates
- 9 Dec 2016to Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
- IORT must be technically feasible
- Histology supports diagnosis of GBM
Who cannot join
- 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
Show all 11Show fewer
- 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
- Active egress of fluids from a ventricular defect
- In-field risk organs and/or IORT dose >8 Gy to any risk organ
Trial locations and contacts
19 sites in 8 countries.
19 sites in 8 countries
Germany7 sites
University Hospital Augsburg
Augsburg, 86156
Charité - Universitätsmedizin
Berlin, 13353
St. Georg Hospital
Leipzig
University Hospital Mannheim
Mannheim, 68167
Technical University of Munich (TUM), Department of Radiation Oncology
Munich, 81675
Klinikum Stuttgart
Stuttgart, 70174
Helios University Hospital Wuppertal
Wuppertal, 42283
United States5 sites
Long Island Jewish Medical Center, North Shore University Hospital
Lake Success, New York, 11042
Stritch School of Medicine Loyola University
Maywood, Illinois, 60153
West Virginia University
Morgantown, West Virginia, 26506-9260
Lenox Hill Hospital, Hofstra Northwell School of Medicine
New York, New York, 10028
Barrow Neurological Institute (SJHMC)
Phoenix, Arizona, 85013
Spain2 sites
Catalan Institute of Oncology (ICO)
Barcelona, 08908
Hospital Reina Sofia
Córdoba
Canada1 site
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4
China1 site
Beijing Tian Tan Hospital, Capital Medical University
Beijing, 100050
South Korea1 site
Gangnam Severance Hospital, Yonsei University College of Medicine
Seoul, 06273
About this study
Official title: A Multicenter Randomized Phase III Trial on INTraoperative RAdiotherapy in Newly Diagnosed GliOblastoma Multiforme (INTRAGO II)
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
- Being tested
- Standard surgery, Intraoperative radiotherapy, Radiochemotherapy, Temozolomide
- Keywords
- Glioblastoma, Intraoperative Radiotherapy, Radiotherapy Dose Escalation
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard surgeryProcedure or surgery
Intraoperative radiotherapyRadiation
Also called IORT
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.
RadiochemotherapyRadiation
EBRT to 60 Gy plus 75 mg/m2/d temozolomide
TemozolomideDrug
Adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm (A) | Experimental | 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). Receives: Procedure: Standard surgery; Radiation: Intraoperative radiotherapy; Radiation: Radiochemotherapy; Drug: Temozolomide |
| Control Arm (B) | Active comparator | 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). Receives: Procedure: Standard surgery; Radiation: Radiochemotherapy; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression-Free Survival
Determined according to modified Response Assessment in Neuro-Oncology (RANO) criteria and serial perfusion imaging
Measured: 24 Months
Secondary outcomes (15)
Median Overall Survival
Measured: 24 Months
PFS within a 1-2 cm margin around the cavity
Determined by serial contrast-enhanced MRI scans using modified RANO criteria and serial perfusion imaging
Measured: 24 Months
OS with respect to Age
Median overall survival of patients <65 vs. ≥ 65 years
Measured: 24 Months
PFS with respect to Age
Progression-free survival of patients <65 vs. ≥ 65 years; determined according to modified RANO criteria and serial perfusion imaging
Measured: 24 Months
OS with respect to KPS
Median overall survival of patients with KPS 80-100% vs. 60-70%
Measured: 24 Months
PFS with respect to KPS
Progression-free survival of patients with KPS 80-100% vs. 60-70%; determined according to modified RANO criteria and serial perfusion imaging
Measured: 24 Months
OS with respect to thickness of anticipated T1-Gd-enhancing (remaining) tumor margin
Thickness of anticipated T1-Gd-enhancing (remaining) tumor margin as per the discretion of the surgeon (margin ≥0.5 cm or multiple spots of residual tumor within the cavity vs. <0.5 cm)
Measured: 24 Months
PFS with respect to thickness of anticipated T1-Gd-enhancing (remaining) tumor margin
Thickness of anticipated T1-Gd-enhancing (remaining) tumor margin as per the discretion of the surgeon (margin ≥0.5 cm or multiple spots of residual tumor within the cavity vs. <0.5 cm); determined according to modified RANO criteria and serial perfusion imaging
Measured: 24 Months
OS with respect to extent of resection
Early postoperative MRI scans must be used to determine the extent of resection (EoR). The EoR is given as sum of all maximum diameters of residual lesions in cm. OS will be calculated for the following groups:
- Max Diameter group 0: 0 cm (no residual tumor)
- Max Diameter group 1: >0 to ≤1.5 cm (cumulative if multiple residual lesions)
- Max Diameter group 2: >1.5 cm (cumulative if multiple residual lesions)
Measured: 24 Months
PFS with respect to extent of resection
Early postoperative MRI scans must be used to determine the extent of resection (EoR). The EoR is given as sum of all maximum diameters of residual lesions in cm. PFS will be determined according to modified RANO criteria and serial perfusion imaging for the following groups:
- Max Diameter group 0: 0 cm (no residual tumor)
- Max Diameter group 1: >0 to ≤1.5 cm (cumulative if multiple residual lesions)
- Max Diameter group 2: >1.5 cm (cumulative if multiple residual lesions)
Measured: 24 Months
OS with respect to MGMT promoter methylation status
OS in patients with promoter methylation vs. no promoter methylation
Measured: 24 Months
PFS with respect to MGMT promoter methylation status
PFS in patients with promoter methylation vs. no promoter methylation; determined according to modified RANO criteria and serial perfusion imaging
Measured: 24 Months
Quality of Life (QoL) questionnaire
Assessed by European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaires (QLQ C30/BN20)
Measured: 24 Months
Activities of daily living (ADL), assessed using the Barthel Index (Mahoney & Barthel, 1965).
Change in functional outcomes as measured by BI from its baseline value.
Measured: 24 Months
Radiation-related (acute / early delayed / late) neurotoxicity
Assessed by regular neurological examinations and serial MRI scans
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study start9 Dec 2016
- Primary completionNov 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- Carl Zeiss Meditec AG, University of California, Los Angeles
- Responsible party
- Principal investigator, Frank A. Giordano, Heidelberg University
- Investigators
- Frank A. Giordano, MD, Principal investigator, Department of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, GermanyKevin Petrecca, MD, Principal investigator, Department of Neurosurgery, Montréal Neurological, Institute and Hospital, Montréal, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685605
- Sponsor's protocol ID
- INTRAGO-II
- Other IDs
- ARO-2016-1, AG-NRO-03
- Acronym
- INTRAGO-II
- Status last verified
- Oct 2025
- First submitted
- 5 Feb 2016
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25535398Sarria 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.
PubMed 31629553Ayala 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.
PubMed 37150259Cifarelli 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.
PubMed 34858846Sarria 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.
PubMed 34778080Giordano FA, Ganslandt O, Munter MW, Combs SE, Diehl C, Meyer B, Herrlinger U, Schneider M, Kahl KH, Shiban E, Goenka A, Schulder M, Lucas A, Plans G, Brehmer S, Ruder AM, Garcia-Cabezas S, Solivera J, Cifarelli CP, Wenz F, Sarria GR, Pope WB, Layer JP, Tsien CI, Petrecca K; INTRAGO-II Study Group. Dose escalation with intraoperative radiotherapy in newly diagnosed glioblastoma (INTRAGO-II): an open-label, multicentre, randomised, controlled, phase 3 trial. Lancet Oncol. 2026 Jul;27(7):864-878. doi: 10.1016/S1470-2045(26)00235-4.
PubMed 42372746Giordano 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.
PubMed 29528443
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Phase III Trial on INTraoperative RAdiotherapy in Newly Diagnosed GliOblastoma Multiforme (INTRAGO II)
- ClinicalTrials.gov ID
- NCT02685605
- Acronym / sponsor ID
- INTRAGO-II / INTRAGO-II
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, Intraoperative Radiotherapy, Radiotherapy Dose Escalation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Collaborators
- Carl Zeiss Meditec AG, University of California, Los Angeles
- Study start
- 9 Dec 2016 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm (A) | Experimental | Procedure: Standard surgery, Radiation: Intraoperative radiotherapy, Radiation: Radiochemotherapy, Drug: TemozolomideStandard 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). |
| Control Arm (B) | Active comparator | Procedure: Standard surgery, Radiation: Radiochemotherapy, Drug: TemozolomideStandard 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard surgery | Procedure or surgery | Control Arm (B), Experimental Arm (A) |
| Intraoperative radiotherapyAlso: IORTDose 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 | Experimental Arm (A) |
| RadiochemotherapyEBRT to 60 Gy plus 75 mg/m2/d temozolomide | Radiation | Control Arm (B), Experimental Arm (A) |
| TemozolomideAdjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days). | Drug | Control Arm (B), Experimental Arm (A) |
Primary outcome
Median Progression-Free Survival
Time frame: 24 Months
Determined according to modified Response Assessment in Neuro-Oncology (RANO) criteria and serial perfusion imaging
15 secondary outcomes
Median Overall Survival
Time frame: 24 Months
PFS within a 1-2 cm margin around the cavity
Time frame: 24 Months
OS with respect to Age
Time frame: 24 Months
PFS with respect to Age
Time frame: 24 Months
OS with respect to KPS
Time frame: 24 Months
PFS with respect to KPS
Time frame: 24 Months
OS with respect to thickness of anticipated T1-Gd-enhancing (remaining) tumor margin
Time frame: 24 Months
PFS with respect to thickness of anticipated T1-Gd-enhancing (remaining) tumor margin
Time frame: 24 Months
OS with respect to extent of resection
Time frame: 24 Months
PFS with respect to extent of resection
Time frame: 24 Months
OS with respect to MGMT promoter methylation status
Time frame: 24 Months
PFS with respect to MGMT promoter methylation status
Time frame: 24 Months
Quality of Life (QoL) questionnaire
Time frame: 24 Months
Activities of daily living (ADL), assessed using the Barthel Index (Mahoney & Barthel, 1965).
Time frame: 24 Months
Radiation-related (acute / early delayed / late) neurotoxicity
Time frame: 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Background: PubMed 25535398Giordano 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.
- Background: PubMed 31629553Sarria 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.
- Background: PubMed 37150259Ayala 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.
- Background: PubMed 34858846Cifarelli 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.
- Background: PubMed 34778080Sarria 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.
- Derived from this study: PubMed 42372746Giordano FA, Ganslandt O, Munter MW, Combs SE, Diehl C, Meyer B, Herrlinger U, Schneider M, Kahl KH, Shiban E, Goenka A, Schulder M, Lucas A, Plans G, Brehmer S, Ruder AM, Garcia-Cabezas S, Solivera J, Cifarelli CP, Wenz F, Sarria GR, Pope WB, Layer JP, Tsien CI, Petrecca K; INTRAGO-II Study Group. Dose escalation with intraoperative radiotherapy in newly diagnosed glioblastoma (INTRAGO-II): an open-label, multicentre, randomised, controlled, phase 3 trial. Lancet Oncol. 2026 Jul;27(7):864-878. doi: 10.1016/S1470-2045(26)00235-4.
- Derived from this study: PubMed 29528443Giordano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank A. Giordano, MD principal investigator
Department of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, Germany
Kevin Petrecca, MD principal investigator
Department of Neurosurgery, Montréal Neurological, Institute and Hospital, Montréal, Canada
19 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard surgery, Intraoperative radiotherapy and Radiochemotherapy in people with Glioblastoma, run by Universitätsmedizin Mannheim at 19 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, United States, Spain, Brazil, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Progression-Free Survival (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02685605, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.