LEGATO · Lomustine with or without reirradiation for first progression of glioblastoma: a pragmatic randomized phase III study

Recurrent glioblastoma is an invariably fatal refractory cancer with dismal prognosis. Patients suffer from low quality of life and very burdensome symptoms. This project is proposing an investigator-initiated phase III randomised pragmatic clinical trial. We will assess whether the addition of radiation treatment to lomustine chemotherapy has superior efficacy as compared to lomustine chemotherapy alone for treatment of patients with recurrent glioblastoma. The study will apply minimal patient eligibility criteria, and thus be as close as possible to the routine clinical setting. Cost-effectiveness analysis will be performed to investigate the economic value of adding radiation treatment to lomustine chemotherapy in different countries to support evidence-informed policy decisions. If successful, the outcomes of the project will define a new evidence-based standard of care for recurrent glioblastoma. The proposed research could lead to improved patient survival and quality of life but also improving health system sustainability. This is a multidisciplinary and multistakeholder consortium involving clinical oncologists, radiation oncologists, health economists and patient representatives. The study design was successfully discussed with patients. This action is part of the Cancer Mission cluster of projects on ‘Diagnosis and treatment.”