Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma

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 Criteria:

* Newly diagnosed glioblastoma/gliosarcoma, IDH wild type
* Methylated MGMT promoter
* World Health Organization performance status 0-2
* Age 18-70

Exclusion Criteria:

* Previous malignancy within 3 y or malignancy treated non-curatively
* Previous chemotherapy or radiotherapy involving the head
* Off-protocol tumor-specific treatment
* Serious comorbidity

Conditions3

Interventions2

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