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

Related trials

• Lomustine With and Without Reirradiation for First Progression of Glioblastoma: a Randomized Phase III Study — European Organisation for Research and Treatment of Cancer - EORTC
• A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss — Children's Oncology Group
• A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma — Global Coalition for Adaptive Research
• Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM — CarThera
• Laser Interstitial Thermal Therapy (LITT) and Lomustine (CCNU) for Recurrent Glioblastoma — University of California, Davis
• The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302) — Jasper Gerritsen
• Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma — The University of Texas Health Science Center at San Antonio
• 5FU/LV, Irinotecan, Temozolomide and Bevacizumab for MGMT Silenced, Microsatellite Stable Metastatic Colorectal Cancer. — Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Browse More Trials