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

Project description

Randomised clinical trial to improve glioblastoma treatment

Glioblastoma is a highly aggressive form of brain cancer, and at present, it is generally considered to be incurable. The EU-funded LEGATO project aims to explore a new treatment. It will conduct a phase III randomised clinical trial to determine whether adding radiation therapy to lomustine chemotherapy is more effective than lomustine alone. The study will include a wide range of patients so the results better reflect how treatments work in everyday clinical practice. If successful, the project could become a new standard of care, helping patients live longer and improving their quality of life while making healthcare more efficient. It is part of the EU Cancer Mission cluster Diagnosis & Treatment.

Objective

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.”

Fields of science (EuroSciVoc)

Keywords

Programme(s)

Topic(s)

Funding Scheme

HORIZON-RIA - HORIZON Research and Innovation Actions

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Call for proposal

(opens in new window) HORIZON-MISS-2022-CANCER-01

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Coordinator

ORGANISATION EUROPEENNE POUR LA RECHERCHE ET LE TRAITEMENT DU CANCER AISBL
Net EU contribution
€ 4 492 233,75
Address
Avenue E. Mounier 83
1200 Bruxelles / Brussel
Belgium
Region
Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
Activity type
Research Organisations
Links
Total cost
€ 4 492 233,75

Participants (3)

Partners (2)