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)
Summary description of the study
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 under investigation
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)
Disease under 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)
Exclusion criteria
- 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)
Trial sites
Bellinzona, Lugano, Zurich
(BASEC)
Sponsor
EORTC, Belgique Swiss Group for Clinical Cancer Research (SAKK), Bern
(BASEC)
Contact
Contact Person Switzerland
K. Zackel
+41 31 389 91 91
trials@cluttersakk.chSwiss Group for Clinical Cancer Research (SAKK)
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
08.04.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
EORTC-LEGATO Lomustine with or without reirradiation for first progression of glioblastoma: a randomized phase III study (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
not available
Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available