Phase III Study Comparing Lomustine Alone Versus Lomustine With Reirradiation for Treating First Recurrence of Glioblastoma

What this Trial Is About

Researchers are studying patients with first progression or recurrent glioblastoma, a type of brain tumor that often returns despite initial treatment. This study aims to compare the effectiveness of lomustine alone versus lomustine combined with reirradiation to see if the combination can improve overall survival without reducing quality of life. The study is a randomized Phase III trial sponsored by the European Organisation for Research and Treatment of Cancer and will include patients who have had prior standard chemoradiotherapy and meet specific health criteria. Participants will be randomly assigned to one of two groups one receiving lomustine alone and the other receiving lomustine plus reirradiation. Lomustine is given orally, while reirradiation is administered at least six months after the previous radiotherapy. The trial includes planned interim analyses to evaluate the effectiveness and safety of the treatments. During the study, participants will be closely monitored through overall survival assessments up to 40 months after enrollment. Researchers will also track progression-free survival, health-related quality of life, toxicity profiles, neurocognitive functioning, and treatment responses. Safety and quality of life will be assessed throughout the treatment and follow-up periods, ensuring comprehensive evaluation of the combined therapy compared to lomustine alone.

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