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.

Interventions

• Temozolomide · DRUG

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

• Lomustine · DRUG

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

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (20)

• University Hospital Graz, Graz, Austria · Not yet recruiting
• Medizinische Universität Innsbruck, Innsbruck, Austria · Not yet recruiting
• Kepler University Hospital, Linz, Austria · Recruiting
• University Hospital St. Pölten, Sankt Pölten, Austria · Enrolling by invitation
• Aarhus University Hospital, Aarhus, Denmark · Recruiting
• Haukeland University Hospital, Bergen, Norway · Recruiting
• Sorlandet Sykehus, Kristiansand, Norway · Recruiting
• Oslo University Hospital, Oslo, Norway · Recruiting
• Stavanger University Hospital, Stavanger, Norway · Not yet recruiting
• St Olavs Hospital, Trondheim, Norway · Not yet recruiting
• Gävle Hospital, Gävle, Sweden · Recruiting
• Sahlgrenska University Hospital, Gothenburg, Sweden · Recruiting
• Ryhov County Hospital, Jönköping, Sweden · Recruiting
• Kalmar Country Hospital, Kalmar, Sweden · Recruiting
• Skåne University Hospital, Lund, Sweden · Not yet recruiting
• Örebro University Hospital, Örebro, Sweden · Recruiting
• Karolinska Institutet, Stockholm, Sweden · Enrolling by invitation
• Sundsvall Hospital, Sundsvall, Sweden · Enrolling by invitation
• Norrlands Universitetssjukhus, Umea, Sweden, Umeå, Sweden · Recruiting
• Uppsala University Hospital, Uppsala, Sweden · Recruiting