Daily Temozolomide for Elderly Patients With Unmethylated MGMT- Promoter Newly Diagnosed GliOblatoma

Inclusion criteria

• Age ≥65 years.
• Histopathologically confirmed newly diagnosed WHO grade 4, IDH wild-type GBM
• Unmethylated MGMT promoter, according to local assessment
• Completed treatment with 40 Gy in 15 fractions over three weeks, with concurrent TMZ, within six weeks prior to enrollment
• Eastern Cooperative Oncology Group (ECOG) performance status scale of 0, 1, or 2.
• Karnofsky Performance Status (KPS) ≥60.
• Adequate organ function, as defined by the following laboratory values obtained within 28 days prior to enrollment:

• Absolute neutrophil count (ANC) >1.5 × 10⁹/L (1,500 cells/mm³).
• Platelet count >100 × 10⁹/L (100,000 cells/mm³).
• Serum creatinine <1.5 times the upper limit of normal.
• Total serum bilirubin <1.5 times the upper limit of normal.
• ALT (SGPT) <2.5 times the upper limit of normal and/or AST (SGOT) <2.5 times the upper limit of normal.
• Signed informed consent (and assent, if applicable) must be obtained from the participant or their legal representative, ensuring the participant's ability to adhere to the study requirements.

Exclusion criteria

• Diffuse leptomeningeal involvement at the time of diagnosis.
• Inability to undergo contrast-enhanced magnetic resonance imaging (MRI)
• Known hypersensitivity to TMZ components or Dacarbazine
• Severe myelosuppression
• Active hepatitis B infection
• Severe or uncontrolled medical conditions (e.g., active systemic infection, diabetes, hypertension, coronary artery disease, or psychiatric disorders) that, in the investigator's judgment, could compromise patient safety or impede study completion.
• History of prior or second invasive malignancy, except for:

• Non-melanoma skin cancer.
• Completely resected cervical carcinoma in situ.
• Low risk prostate cancer or under active surveillance.
• Other cancers for which the subject has completed potentially curative treatment more than 3 years prior to study entry are allowed.