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

Condition(s) studied

Investigational drug(s) / intervention(s)

Temozolomide: In the experimental treatment arm: a combination of Temozolomide and Lomustine, taken together, two separate pills

Lomustine: In the experimental treatment arm: a combination of Temozolomide and Lomustine, taken together, two separate pills

Study 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

Primary outcome measure(s)

• overall survival — Assessed from day of randomization to event or last day of follow-up (FU). Aanlyzed 36 months after last inclusion ensures that all patients have a potential of minimum 36 months FU
  visualized with Kaplan-Meier plot, tested with log-rank test

Trial sites (20)

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