Lomustine with or without reirradiation for first progression of glioblastoma, LEGATO, EORTC-2227-BTG: study protocol for a randomized phase III study.
Glioblastoma
/ pathology
Humans
Lomustine
/ administration & dosage
Brain Neoplasms
/ radiotherapy
Disease Progression
Antineoplastic Agents, Alkylating
/ therapeutic use
Multicenter Studies as Topic
Progression-Free Survival
Quality of Life
Randomized Controlled Trials as Topic
Chemoradiotherapy
/ methods
Clinical Trials, Phase III as Topic
Pragmatic Clinical Trials as Topic
Time Factors
Glioblastoma
LEGATO
Lomustine
Progression
Randomized controlled trial
Reirradiation
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
07 Jun 2024
07 Jun 2024
Historique:
received:
02
05
2024
accepted:
30
05
2024
medline:
8
6
2024
pubmed:
8
6
2024
entrez:
7
6
2024
Statut:
epublish
Résumé
Chemotherapy with lomustine is widely considered as standard treatment option for progressive glioblastoma. The value of adding radiotherapy to second-line chemotherapy is not known. EORTC-2227-BTG (LEGATO, NCT05904119) is an investigator-initiated, pragmatic (PRECIS-2 score: 34 out of 45), randomized, multicenter phase III trial in patients with first progression of glioblastoma. A total of 411 patients will be randomized in a 1:1 ratio to lomustine (110 mg/m EORTC-2227-BTG (LEGATO) is a publicly funded pragmatic phase III trial designed to clarify the efficacy of adding reirradiation to chemotherapy with lomustine for the treatment of patients with first progression of glioblastoma. ClinicalTrials.gov NCT05904119. Registered before start of inclusion, 23 May 2023.
Sections du résumé
BACKGROUND
BACKGROUND
Chemotherapy with lomustine is widely considered as standard treatment option for progressive glioblastoma. The value of adding radiotherapy to second-line chemotherapy is not known.
METHODS
METHODS
EORTC-2227-BTG (LEGATO, NCT05904119) is an investigator-initiated, pragmatic (PRECIS-2 score: 34 out of 45), randomized, multicenter phase III trial in patients with first progression of glioblastoma. A total of 411 patients will be randomized in a 1:1 ratio to lomustine (110 mg/m
DISCUSSION
CONCLUSIONS
EORTC-2227-BTG (LEGATO) is a publicly funded pragmatic phase III trial designed to clarify the efficacy of adding reirradiation to chemotherapy with lomustine for the treatment of patients with first progression of glioblastoma.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT05904119. Registered before start of inclusion, 23 May 2023.
Identifiants
pubmed: 38849943
doi: 10.1186/s13063-024-08213-7
pii: 10.1186/s13063-024-08213-7
doi:
Substances chimiques
Lomustine
7BRF0Z81KG
Antineoplastic Agents, Alkylating
0
Banques de données
ClinicalTrials.gov
['NCT05904119']
Types de publication
Journal Article
Clinical Trial Protocol
Langues
eng
Sous-ensembles de citation
IM
Pagination
366Subventions
Organisme : Horizon 2020 Framework Programme
ID : 101103655
Informations de copyright
© 2024. The Author(s).
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