Periodic Reporting for period 1 - LEGATO (Lomustine with or without reirradiation for first progression of glioblastoma: a pragmatic randomized phase III study)
Okres sprawozdawczy: 2023-06-01 do 2024-05-31
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. 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.
The activation of the LEGATO clinical trial is progressing according to plan. All partners have contributed with their expertise to the development of the clinical trial protocol. The clinical trial is open for patient recruitment in the first clinical site since March 2024. The first patient was recruited in April 2024.
On the health economics side, as it was planned, the activities have been initiated at project start. The explorative work was carried out, input for the clinical trial protocol was provided and input from the clinical experts was collected. These resulted in the conceptual value framework, which was submitted as the first deliverable from this work.
Finally, regarding communication and dissemination, all milestones and deliverables were completed in time. Project website, social media platforms and newsletters were launched, and the study protocol published in open access format. The deliverable of Plan for dissemination and exploitation was prepared. The first webinar was released. Active communication is carried out according to progress of the clinical trial.
In conclusion, the project is progressing well and according to the planed timelines.
On the health economics side, as it was planned, the activities have been initiated at project start. The explorative work was carried out, input for the clinical trial protocol was provided and input from the clinical experts was collected. These resulted in the conceptual value framework, which was submitted as the first deliverable from this work.
Finally, regarding communication and dissemination, all milestones and deliverables were completed in time. Project website, social media platforms and newsletters were launched, and the study protocol published in open access format. The deliverable of Plan for dissemination and exploitation was prepared. The first webinar was released. Active communication is carried out according to progress of the clinical trial.
In conclusion, the project is progressing well and according to the planed timelines.
It is too early. We haven't completed the clinical trial. Data are not yet available