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Brain cancer breakthrough? trial adds radiation during surgery to fight glioblastoma

NCT ID NCT02685605

Disease control Sponsor: Universitätsmedizin Mannheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether giving a dose of radiation directly to the tumor site during surgery (intraoperative radiotherapy) can help people with a newly diagnosed aggressive brain cancer called glioblastoma live longer without their cancer growing. The study involves 314 adults aged 18 to 80 who are healthy enough for surgery. The goal is to see if adding this extra radiation to the usual treatment plan improves outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

314 people

The number who actually took part.

Started

Dec 2016

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

glioblastoma glioma susceptibility 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glioblastoma

Contacts and locations

Locations

  • Barrow Neurological Institute (SJHMC)

    Phoenix, Arizona, 85013, United States

  • Beijing Tian Tan Hospital, Capital Medical University

    Beijing, 100050, China

  • Catalan Institute of Oncology (ICO)

    Barcelona, 08908, Spain

  • Charité - Universitätsmedizin

    Berlin, 13353, Germany

  • Gangnam Severance Hospital, Yonsei University College of Medicine

    Seoul, 06273, South Korea

  • Helios University Hospital Wuppertal

    Wuppertal, 42283, Germany

  • Hospital Alemão Oswaldo Cruz

    São Paulo, 01323-020, Brazil

  • Hospital Reina Sofia

    Córdoba, Spain

  • Klinikum Stuttgart

    Stuttgart, 70174, Germany

  • Lenox Hill Hospital, Hofstra Northwell School of Medicine

    New York, New York, 10028, United States

  • Long Island Jewish Medical Center, North Shore University Hospital

    Lake Success, New York, 11042, United States

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec, H3A 2B4, Canada

  • St. Georg Hospital

    Leipzig, Germany

  • Stritch School of Medicine Loyola University

    Maywood, Illinois, 60153, United States

  • Technical University of Munich (TUM), Department of Radiation Oncology

    Munich, 81675, Germany

  • The London Clinic

    London, W1G 6BW, United Kingdom

  • University Hospital Augsburg

    Augsburg, 86156, Germany

  • University Hospital Mannheim

    Mannheim, 68167, Germany

  • West Virginia University

    Morgantown, West Virginia, 26506-9260, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.