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)
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
Bellinzona, Lugano, Zürich
(BASEC)
Sponsor
EORTC, Belgique Swiss Group for Clinical Cancer Research (SAKK), Bern
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
K. Zackel
+41 31 389 91 91
trials@cluttersakk.chSwiss Group for Clinical Cancer Research (SAKK)
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
08.04.2025
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
EORTC-LEGATO Lomustine with or without reirradiation for first progression of glioblastoma: a randomized phase III study (BASEC)
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Öffentlicher Titel
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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