The treatment of patients with glioblastoma, where the disease progresses for the first time, with lomustine and radiation or lomustine without radiation - a randomized phase III study (LEGATO)
Descrizione riassuntiva dello studio
There are various types of brain tumors, including glioblastoma. When diagnosed with glioblastoma, surgery, radiation therapy of the brain, and/or medication therapy typically follows. It is very common for a relapse (recurrence) to occur after the initial treatment of glioblastoma. This means that the tumor begins to grow again. Worldwide, individuals with a glioblastoma recurrence are most commonly treated with the substance lomustine, a chemotherapy drug. Sometimes, the affected individuals also receive radiation therapy a second time. However, it is still unknown whether the combination of lomustine and radiation is more effective than treatment with lomustine alone. Therefore, in this study, we investigate whether the combination of lomustine and radiation therapy is generally safe and more effective for a glioblastoma recurrence than lomustine alone.
(BASEC)
Intervento studiato
To determine whether and how the combination of lomustine and radiation therapy works, study participants will be randomly assigned to two groups:
• Participants in Group 1 (standard treatment) will receive chemotherapy with lomustine.
• Participants in Group 2 (experimental treatment) will receive chemotherapy with lomustine and additionally radiation therapy.
All participants will take lomustine in the form of a tablet every six weeks. Each six-week period is referred to as a 'cycle.' Lomustine will be taken every six weeks until it no longer works or causes severe side effects. Participants in Group 2 (experimental treatment) will also receive radiation in the tumor area for 10 days. The radiation treatments will take place in the first two weeks of the first cycle on five days each week.
(BASEC)
Malattie studiate
Glioblastoma
(BASEC)
- Patients with first-time progression or recurrence of glioblastoma after first-line treatment - Measurable disease according to RANO criteria with a maximum tumor diameter of 5 cm - Candidates for treatment with lomustine as assessed by the physician. (BASEC)
Criteri di esclusione
- Previous cancer treatment for recurrent glioblastoma (except surgery). - Significant reduction in platelet and/or white blood cell count - Severe kidney dysfunction as assessed by the investigator (BASEC)
Luogo dello studio
Bellinzona, Lugano, Zurigo
(BASEC)
Sponsor
EORTC, Belgique Swiss Group for Clinical Cancer Research (SAKK), Bern
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
K. Zackel
+41 31 389 91 91
trials@cluttersakk.chSwiss Group for Clinical Cancer Research (SAKK)
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
08.04.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
EORTC-LEGATO Lomustine with or without reirradiation for first progression of glioblastoma: a randomized phase III study (BASEC)
Titolo accademico
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Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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