RecruitingPhase 3NCT06419946

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)


Sponsor

Vastra Gotaland Region

Enrollment

200 participants

Start Date

Feb 1, 2025

Study Type

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

Min Age: 18 YearsMax Age: 70 Years

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

DRUGTemozolomide

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

DRUGLomustine

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


Locations(20)

University Hospital Graz

Graz, Austria

Medizinische Universität Innsbruck

Innsbruck, Austria

Kepler University Hospital

Linz, Austria

University Hospital St. Pölten

Sankt Pölten, Austria

Aarhus University Hospital

Aarhus, Denmark

Haukeland University Hospital

Bergen, Norway

Sorlandet Sykehus

Kristiansand, Norway

Oslo University Hospital

Oslo, Norway

Stavanger University Hospital

Stavanger, Norway

St Olavs Hospital

Trondheim, Norway

Gävle Hospital

Gävle, Sweden

Sahlgrenska University Hospital

Gothenburg, Sweden

Ryhov County Hospital

Jönköping, Sweden

Kalmar Country Hospital

Kalmar, Sweden

Skåne University Hospital

Lund, Sweden

Örebro University Hospital

Örebro, Sweden

Karolinska Institutet

Stockholm, Sweden

Sundsvall Hospital

Sundsvall, Sweden

Norrlands Universitetssjukhus, Umea, Sweden

Umeå, Sweden

Uppsala University Hospital

Uppsala, Sweden

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NCT06419946


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