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Could a second round of radiation boost survival in returning brain tumors?

NCT ID NCT05904119

Disease control Sponsor: European Organisation for Research and Treatment of Cancer - EORTC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether adding a second round of radiation to the chemotherapy drug lomustine helps people with recurrent glioblastoma live longer. About 411 adults whose brain tumor has returned after standard treatment will be randomly assigned to get lomustine alone or lomustine plus targeted radiation. The goal is to see if the combination improves overall survival without harming quality of life.

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

About 411 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

18 years and older

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: * Before patient's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations. * Patients with first progression or recurrent glioblastoma after standard chemoradiotherapy (any treatment other than use of nitroureas) having occurred at least 6 months after the end of prior radiotherapy * Measurable disease according to RANO criteria with a maximum tumour diameter of 5 cm (local investigator assessment) * In case of surgery for recurrence: fully recovered from surgery, confirmation of recurrence by histology, and patient fit for treatment as per local investigator assessment. * Histologically proven diagnosis of glioblastoma, IDH wildtype per WHO 2021 classification and local assessment of tissue from diagnosis or recurrence * Initial treatment of newly diagnosed glioblastoma by maximal safe resection and postsurgical concurrent conventionally fractionated or abbreviated (minimum 15 fractions) chemoradiotherapy with or without maintenance chemotherapy with temozolomide (patient must have received at least one dose) * Stable or decreasing dose of steroids for 7 days prior to enrolment * Age ≥ 18 years * WHO Performance status of 0-2 * Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of study treatment. * Patients of childbearing / reproductive potential must agree to use adequate birth control measures during the study treatment period and for at least 6 months after the last dose of study treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. * Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment. * Non-sterile males must use contraception during treatment and for 6 months after the last dose. * Non-sterile males must avoid sperm donation for the duration of the study and for at least 6 months after the last dose of study treatment. Exclusion Criteria: * Any prior anticancer treatment for recurrent glioblastoma (except surgery) * Significant reduction in thrombocyte and/or leukocyte counts as well as severe renal impairment according to investigator's opinion * History or present acute leukaemia or any myeloid disease * Known hypersensitivity to the active components or excipients of lomustine * Known coeliac disease or wheat allergy * Live attenuated vaccine in the 3 months prior to lomustine initiation * Any serious or uncontrolled medical condition (e.g., infections, chronic alcoholism, drug addiction) or abnormality, in the judgment of the investigator that prohibits obtaining informed consent, safe participation and study completion * Known contraindication to imaging tracer or any product of contrast media and Magnetic Resonance Imaging (MRI) contraindications * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial.

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Conditions

The condition(s) this trial relates to.

glioblastoma

As listed by the trial registrant

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

First progression of glioblastoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    42 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.O Landeskrankenhaus - Innsbruck Universitaetsklinik

    RECRUITING

    Innsbruck, 6020, Austria

  • AZORG

    RECRUITING

    Aalst, 9300, Belgium

  • Aarhus University Hospitals - Region Midtjylland - Aarhus University Hospital-Skejby

    RECRUITING

    Aarhus, 8200, Denmark

  • Assistance Publique Hopitaux Paris- APHP - APHP Nord - Univ De Paris Cite - Hop. Saint Louis

    RECRUITING

    Paris, France

  • Assistance Publique Hopitaux Paris- APHP - APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (233)

    RECRUITING

    Paris, 75013, France

  • Azienda ospedaliero Univ Policlinico Umberto I

    RECRUITING

    Roma, 00161, Italy

  • CHRU de Lille

    RECRUITING

    Lille, 59037, France

  • CHU d'Amiens - CHU Amiens Picardie - Site Sud

    RECRUITING

    Amiens, 80054, France

  • CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer

    RECRUITING

    Lyon, France

  • CHU de Nice - Hôpital Pasteur

    RECRUITING

    Nice, 06000, France

  • CLCC - Jean Perrin

    RECRUITING

    Clermont-Ferrand, 63000, France

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • ETZ Tilburg - ETZ - St. Elisabethziekenhuis

    RECRUITING

    Tilburg, 5022, Netherlands

  • Erasmus MC

    RECRUITING

    Rotterdam, Netherlands

  • Grand Hopital de Charleroi - Site Les Viviers

    RECRUITING

    Gilly, 6060, Belgium

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)

    RECRUITING

    L'Hospitalet de Llobregat, 08908, Spain

  • IRCCS - Istituto Oncologico Veneto

    RECRUITING

    Padova, 35128, Italy

  • IRCCS-Ospedale Bellaria-Bologna

    RECRUITING

    Bologna, 40139, Italy

  • Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (381)

    RECRUITING

    Badalona, 08916, Spain

  • Institut Public De Cancerologie Strauss Europe-Strauss Institute

    RECRUITING

    Strasbourg, 67200, France

  • Institut de Cancerologie de l´Ouest (ICO) - Saint Herblain

    RECRUITING

    Saint-Herblain, 44805, France

  • Institut du Cancer de Montpellier

    RECRUITING

    Montpellier, France

  • Istituto Clinico Humanitas

    RECRUITING

    Milan, 20089, Italy

  • Kepler University Hospital - Neuromed campus

    RECRUITING

    Linz, 4020, Austria

  • Leiden University Medical Centre

    RECRUITING

    Leiden, Netherlands

  • Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern

    RECRUITING

    Munich, 81377, Germany

  • Masaryk Memorial Cancer Institute

    RECRUITING

    Brno, Czechia

  • Oncology Institute of Southern Switzerland (IOSI) - Ospedale San Giovanni

    RECRUITING

    Bellinzona, 6500, Switzerland

  • Oslo University Hospital - Radiumhospitalet

    RECRUITING

    Oslo, NO 0379, Norway

  • St Olavs University Hospital - St. Olavs Hospital, Trondheim University Hospital

    RECRUITING

    Trondheim, NO 7030, Norway

  • U.Z. Leuven - Campus Gasthuisberg

    RECRUITING

    Leuven, 3000, Belgium

  • ULSS 9 Scaligera Veneto - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital

    RECRUITING

    Legnago, 37045, Italy

  • Univ. Knappschaft Krankenhaus Bochum

    RECRUITING

    Bochum, 44892, Germany

  • UniversitaetsSpital Zurich - Neurology Clinic

    RECRUITING

    Zurich, 8091, Switzerland

  • Universitaetskliniken Regensburg - Universitaetsklinikum Regensburg

    TERMINATED

    Regensburg, 93053, Germany

  • Universitaetsklinikum - Essen

    RECRUITING

    Essen, 45147, Germany

  • Universitaetsklinikum Erlangen-Schwabachanlage

    TERMINATED

    Erlangen, Germany

  • Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital

    RECRUITING

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Koeln

    RECRUITING

    Cologne, 50937, Germany

  • Universitaetsklinikum Tuebingen- Crona Kliniken

    RECRUITING

    Tübingen, 72076, Germany

  • Universitaetsklinikum Wien - AKH unikliniken

    RECRUITING

    Vienna, Austria

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, 9000, Belgium

  • Universitätsklinikum Leipzig-Klinik für Strahlentherapie und Radioonkologie

    TERMINATED

    Leipzig, 04103, Germany

  • Ziekenhuis aan de Stroom (ZAS) - ZAS Augustinus (previous GZA)

    RECRUITING

    Wilrijk, 2610, Belgium