Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma
Phase III Trial of Temozolomide/Lomustine (TMZ/LOM) Combination Therapy vs. Standard TMZ Therapy for Newly Diagnosed MGMT Promoter Methylated Glioblastoma (IDHwt) Patients +/- Tumor Treating Fields (Optune)
Vastra Gotaland Region
200 participants
Feb 1, 2025
INTERVENTIONAL
Conditions
Summary
Background: Glioblastoma (GBM) is notoriously difficult to treat, with current therapies often extending life by only a few months. The standard treatment involves surgery followed by radiation and chemotherapy with Temozolomide (TMZ). The efficacy of TMZ, however, is significantly enhanced when the tumor's o6-methylguanine-DNA-methyltransferase (MGMT) gene is methylated. Recent studies, such as the NOA-09 trial, have suggested that adding Lomustine (LOM) to TMZ could improve outcomes for patients with this specific tumor profile. Hypothesis: The investigators hypothesize that the addition of LOM to the TMZ regimen will lead to significantly improved survival rates among patients with newly diagnosed glioblastoma who have a methylated MGMT promoter compared to those receiving only TMZ. Treatment Plans: The study will randomly assign participants to two groups: * Control Group: Standard treatment with TMZ during and after radiation therapy. * Experimental Group: TMZ combined with LOM, starting on the first day of radiation therapy. Outcome Measures: The primary outcome measure will be survival. Other outcomes will include progression-free survival (time from randomization until tumor progression or death), safety profiles (adverse effects of the treatments), and quality of life measures as well as neurocognitive outcomes.
Eligibility
Inclusion Criteria4
- Newly diagnosed glioblastoma/gliosarcoma, IDH wild type
- Methylated MGMT promoter
- World Health Organization performance status 0-2
- Age 18-70
Exclusion Criteria4
- Previous malignancy within 3 y or malignancy treated non-curatively
- Previous chemotherapy or radiotherapy involving the head
- Off-protocol tumor-specific treatment
- Serious comorbidity
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Interventions
In the experimental treatment arm: a combination of Temozolomide and Lomustine, taken together, two separate pills
In the experimental treatment arm: a combination of Temozolomide and Lomustine, taken together, two separate pills
Locations(20)
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NCT06419946