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)
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
- 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)
Lieu de l’étude
Bellinzona, Lugano, Zurich
(BASEC)
Sponsor
EORTC, Belgique Swiss Group for Clinical Cancer Research (SAKK), Bern
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
K. Zackel
+41 31 389 91 91
trials@cluttersakk.chSwiss Group for Clinical Cancer Research (SAKK)
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
08.04.2025
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
EORTC-LEGATO Lomustine with or without reirradiation for first progression of glioblastoma: a randomized phase III study (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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