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

Project Information

LEGATO

Grant agreement ID: 101103655

DOI

10.3030/101103655

EC signature date 21 April 2023

Start date 1 June 2023

End date 31 May 2028

Funded under

• Health

Total cost

€ 5 214 733,75

EU contribution

€ 5 214 733,75

Coordinated by

EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER AISBL
Belgium

Periodic Reporting for period 2 - LEGATO (Lomustine with or without reirradiation for first progression of glioblastoma: a pragmatic randomized phase III study)

Reporting period: 2024-06-01 to 2025-11-30

Summary of the context and overall objectives of the project

Recurrent glioblastoma is an invariably fatal refractory cancer with dismal prognosis. Patients suffer from low quality of life and very burdensome symptoms. This project will conduct 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. If successful, this project 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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The LEGATO clinical trial is progressing according to plan. As of 30 November 2025, 132 patients (155 patients as of 16 February 2026, period 3) were recruited out of the total sample size of 411 patients. There are 41 clinical sites authorized to enrol patients from 11 countries as of 30th Nov 2025 (42 clinical sites as of 16 February 2026, period 3). Accrual is slightly slower than expected. Actions were taken and the accrual is going increasingly better. Accrual is expected to be completed by June 2027 instead of March 2027, as previously planned. There is still a possibility of completing the project in time, but it will need to be confirmed at a later stage. According to feedback from clinicians, the study is scientifically sound and there is a huge interest in the neurooncological community. Thus, we are confident about the contribution from the participating sites and we foresee to complete patient recruitment with limited delay. On the health economics side, as it was planned, the activities have been ongoing since project start. After constructing the conceptual value framework, which was submitted as the first deliverable from this work, the model development and the corresponding data collection were started. Finally, regarding communication and dissemination, all milestones and deliverables were completed in time. Project website, social media platforms and newsletters are regularly used, and a new article on health economics was published in open access format. The Plan for dissemination and exploitation deliverable is followed. Active communication is carried out on various platforms according to progress of the clinical trial.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

It is too early. We haven't completed the clinical trial. Data are not yet available

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