Lomustine With and Without Reirradiation for First Progression of Glioblastoma: a Randomized Phase III Study

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.

NCT Number	NCT05904119
Lead Sponsor	European Organisation for Research and Treatment of Cancer - EORTC Collaborators: Swiss Cancer Institute
Conditions	First Progression of Glioblastoma
Enrollment	411 participants
Start Date	2024-03-15
Primary Completion	2027-09 (estimated)
Study Completion	2028-02 (estimated)
Updated on ClinicalTrials.gov	2026-06-08