At a glance
ClinicalIndex Comparison Record- ✓First progression or recurrent glioblastoma after standard chemoradiotherapy
- ✓Progression occurred at least 6 months after end of prior radiotherapy
- ✓Measurable disease per RANO criteria with maximum tumor diameter 5 cm
- ✓If surgery for recurrence: fully recovered, recurrence confirmed by histology, fit for treatment
- ✕Any prior anticancer treatment for recurrent glioblastoma except surgery
- ✕Significant reduction in thrombocyte and/or leukocyte counts or severe renal impairment
- ✕History or present acute leukemia or any myeloid disease
- ✕Known hypersensitivity to lomustine components or excipients
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Lomustine With and Without Reirradiation for First Progression of Glioblastoma: a Randomized Phase III Study
In Brief
A Phase 3 clinical trial evaluating Lomustine and Reirradiation for First Progression of Glioblastoma. Currently recruiting, targeting 411 participants across 45 sites in 11 countries.
Signals
Detailed 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.
Study Details
Timeline
Interventions
Oral administration of Lomustine
Given at least 6 months after the end of prior radiotherapy