Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma
Status:
NOT_YET_RECRUITING
Trial end date:
2031-12-15
Target enrollment:
Participant gender:
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.
Phase:
PHASE3
Details
Lead Sponsor:
Vastra Gotaland Region
Collaborators:
Aarhus University Hospital Eskilstuna Lasarettet Gvle Hospital Haukeland University Hospital Helse Stavanger HF Kalmar County Hospital Karlstad Central Hospital Karolinska Institutet Oslo University Hospital Region rebro County Ryhov County Hospital Sahlgrenska University Hospital Skane University Hospital Sorlandet Hospital HF St. Olavs Hospital University Hospital, Ume