Actively Recruiting
Lomustine With and Without Reirradiation for First Progression of Glioblastoma: a Randomized Phase III Study
Led by European Organisation for Research and Treatment of Cancer - EORTC · Updated on 2026-02-17
411
Participants Needed
43
Research Sites
202 weeks
Total Duration
On this page
Sponsors
E
European Organisation for Research and Treatment of Cancer - EORTC
Lead Sponsor
S
Swiss Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Despite comprehensive multimodal treatment of newly diagnosed glioblastoma, almost all patients suffer from tumour relapse. Currently, no standard of care exists to treat these tumour relapses. Treatment options include repeated surgery (if feasible), systemic therapy (bevacizumab, lomustine, temozolomide re-challenge), reirradiation and best supportive care. Currently, the superiority of combined chemoradiation versus chemotherapy alone remains unproven. Given that lomustine is the standard chemotherapeutic agent for the treatment of recurrent glioblastoma in Europe and the unclear efficacy of reirradiation, we want to explore whether combining lomustine and reirradiation may be a better treatment than lomustine alone. The results of the prospective randomized trial proposed here should demonstrate a significant improvement in overall survival when lomustine is combined with reirradiation in patients with recurrent glioblastoma compared to lomustine alone without adversely affecting quality of survival. The trial will be stopped based on overall survival in a preplanned futility and efficacy interim analysis.
CONDITIONS
Official Title
Lomustine With and Without Reirradiation for First Progression of Glioblastoma: a Randomized Phase III Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 43 locations
1
A.O Landeskrankenhaus - Innsbruck Universitaetsklinik
Innsbruck, Austria, 6020
Actively Recruiting
2
Kepler University Hospital - Neuromed campus
Linz, Austria, 4020
Actively Recruiting
3
Universitaetsklinikum Wien - AKH unikliniken
Vienna, Austria
Actively Recruiting
4
AZORG
Aalst, Belgium, 9300
Actively Recruiting
5
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
6
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
7
Grand Hopital de Charleroi - Site Les Viviers
Gilly, Belgium, 6060
Actively Recruiting
8
U.Z. Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Actively Recruiting
9
Masaryk Memorial Cancer Institute
Brno, Czechia
Actively Recruiting
10
Aarhus University Hospitals - Region Midtjylland - Aarhus University Hospital-Skejby
Aarhus, Denmark, 8200
Actively Recruiting
11
CHU d'Amiens - CHU Amiens Picardie - Site Sud
Amiens, France, 80054
Actively Recruiting
12
CLCC - Jean Perrin
Clermont-Ferrand, France, 63000
Actively Recruiting
13
CHRU de Lille
Lille, France, 59037
Actively Recruiting
14
CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer
Lyon, France
Actively Recruiting
15
Institut du Cancer de Montpellier
Montpellier, France
Actively Recruiting
16
CHU de Nice - Hôpital Pasteur
Nice, France, 06000
Actively Recruiting
17
Assistance Publique Hopitaux Paris- APHP - APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (233)
Paris, France, 75013
Actively Recruiting
18
Assistance Publique Hopitaux Paris- APHP - APHP Nord - Univ De Paris Cite - Hop. Saint Louis
Paris, France
Actively Recruiting
19
Institut de Cancerologie de l´Ouest (ICO) - Saint Herblain
Saint-Herblain, France, 44805
Actively Recruiting
20
Univ. Knappschaft Krankenhaus Bochum
Bochum, Germany, 44892
Actively Recruiting
21
Universitaetsklinikum Koeln
Cologne, Germany, 50937
Actively Recruiting
22
Universitaetsklinikum Erlangen-Schwabachanlage
Erlangen, Germany
Actively Recruiting
23
Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital
Heidelberg, Germany, 69120
Actively Recruiting
24
Universitätsklinikum Leipzig-Klinik für Strahlentherapie und Radioonkologie
Leipzig, Germany, 04103
Actively Recruiting
25
Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern
Munich, Germany, 81377
Actively Recruiting
26
Universitaetsklinikum Regensburg
Regensburg, Germany
Actively Recruiting
27
Universitaetsklinikum Tuebingen- Crona Kliniken
Tübingen, Germany, 72076
Actively Recruiting
28
IRCCS-Ospedale Bellaria-Bologna
Bologna, Italy, 40139
Actively Recruiting
29
ULSS 9 Scaligera Veneto - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital
Legnago, Italy, 37045
Actively Recruiting
30
Istituto Clinico Humanitas
Milan, Italy, 20089
Actively Recruiting
31
IRCCS - Istituto Oncologico Veneto
Padova, Italy, 35128
Actively Recruiting
32
Azienda ospedaliero Univ Policlinico Umberto I
Roma, Italy, 00161
Actively Recruiting
33
Medisch Spectrum Twente
Enschede, Netherlands, 7512 KZ
Actively Recruiting
34
Leiden University Medical Centre
Leiden, Netherlands
Actively Recruiting
35
Erasmus MC
Rotterdam, Netherlands
Actively Recruiting
36
ETZ Tilburg - ETZ - St. Elisabethziekenhuis
Tilburg, Netherlands, 5022
Actively Recruiting
37
Oslo University Hospital - Radiumhospitalet
Oslo, Norway, NO 0379
Actively Recruiting
38
St Olavs University Hospital - St. Olavs Hospital, Trondheim University Hospital
Trondheim, Norway, NO 7030
Actively Recruiting
39
Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
Badalona, Barcelona, Spain
Actively Recruiting
40
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (381)
Badalona, Spain, 08916
Actively Recruiting
41
ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)
L'Hospitalet de Llobregat, Spain, 08908
Actively Recruiting
42
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
43
Oncology Institute of Southern Switzerland (IOSI) - Ospedale San Giovanni
Bellinzona, Switzerland, 6500
Actively Recruiting
Research Team
E
EORTC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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