NCT05904119

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 411 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• First Progression of Glioblastoma

Interventions

Type	Name	Description
DRUG	Lomustine	Oral administration of Lomustine
RADIATION	Reirradiation	Given at least 6 months after the end of prior radiotherapy

Timeline

• Start date: 2024-03-15
• Primary completion: 2027-09-01
• Completion: 2028-02-01
• First posted: 2023-06-15
• Last updated: 2026-02-17

Locations

43 sites across 11 countries: Austria, Belgium, Czechia, Denmark, France, Germany, Italy, Netherlands, Norway, Spain, Switzerland