NCT05904119Recrutement en cours
Lomustine With and Without Reirradiation for First Progression of Glioblastoma: a Randomized Phase III Study
Résumé
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.
Critères d'inclusion
• 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.
Critères d'exclusion
• 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.
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 3
- Type d'étude
- Interventionnelle
- Pays
- Suisse, France, Allemagne, Italie, Autriche, Belgique, Tchéquie, Danemark, Pays-Bas, Norvège, Espagne
- Promoteur
- European Organisation for Research and Treatment of Cancer - EORTC(Réseau / coopérateur)
- N° de protocole
- EORTC-2227-BTG
- Pathologies
- First Progression of Glioblastoma
- Interventions
- Médicament, Radiothérapie
Traitements évalués
- Lomustine
- Reirradiation
Collaborateurs
Swiss Cancer Institute
Lieux · 42
- Bellinzona, SuisseOncology Institute of Southern Switzerland (IOSI) - Ospedale San GiovanniRecrute dans ce centre
- Zurich, SuisseUniversitaetsSpital Zurich - Neurology ClinicRecrute dans ce centre
- Amiens, FranceCHU d'Amiens - CHU Amiens Picardie - Site SudRecrute dans ce centre
- Clermont-Ferrand, FranceCLCC - Jean PerrinRecrute dans ce centre
- Lille, FranceCHRU de LilleRecrute dans ce centre
- Lyon, FranceCHU de Lyon - CHU Lyon - Hopital neurologique Pierre WertheimerRecrute dans ce centre
- Montpellier, FranceInstitut du Cancer de MontpellierRecrute dans ce centre
- Nice, FranceCHU de Nice - Hôpital PasteurRecrute dans ce centre
- Paris, FranceAssistance Publique Hopitaux Paris- APHP - APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (233)Recrute dans ce centre
- Paris, FranceAssistance Publique Hopitaux Paris- APHP - APHP Nord - Univ De Paris Cite - Hop. Saint LouisRecrute dans ce centre
- Saint-Herblain, FranceInstitut de Cancerologie de l´Ouest (ICO) - Saint HerblainRecrute dans ce centre
- Strasbourg, FranceInstitut Public De Cancerologie Strauss Europe-Strauss InstituteRecrute dans ce centre
- Bochum, AllemagneUniv. Knappschaft Krankenhaus BochumRecrute dans ce centre
- Cologne, AllemagneUniversitaetsklinikum KoelnRecrute dans ce centre
- Essen, AllemagneUniversitaetsklinikum - EssenRecrute dans ce centre
- Heidelberg, AllemagneUniversitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head HospitalRecrute dans ce centre
- Munich, AllemagneLudwig-Maximilians-Universitaet Muenchen - Campus GrosshadernRecrute dans ce centre
- Tübingen, AllemagneUniversitaetsklinikum Tuebingen- Crona KlinikenRecrute dans ce centre
- Bologna, ItalieIRCCS-Ospedale Bellaria-BolognaRecrute dans ce centre
- Legnago, ItalieULSS 9 Scaligera Veneto - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis HospitalRecrute dans ce centre
- Milan, ItalieIstituto Clinico HumanitasRecrute dans ce centre
- Padova, ItalieIRCCS - Istituto Oncologico VenetoRecrute dans ce centre
- Roma, ItalieAzienda ospedaliero Univ Policlinico Umberto IRecrute dans ce centre
- Innsbruck, AutricheA.O Landeskrankenhaus - Innsbruck UniversitaetsklinikRecrute dans ce centre
- Linz, AutricheKepler University Hospital - Neuromed campusRecrute dans ce centre
- Vienna, AutricheUniversitaetsklinikum Wien - AKH uniklinikenRecrute dans ce centre
- Aalst, BelgiqueAZORGRecrute dans ce centre
- Brussels, BelgiqueCliniques Universitaires Saint-LucRecrute dans ce centre
- Ghent, BelgiqueUniversitair Ziekenhuis GentRecrute dans ce centre
- Gilly, BelgiqueGrand Hopital de Charleroi - Site Les ViviersRecrute dans ce centre
Au total, dans le monde, 42 des 45 centres listés au registre recrutent ; les 3 autres ne recrutent pas actuellement.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 8 juin 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
+ 12 autres lieux
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.