Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07476794
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT07476794
Study Brief:
Protocol Section:
NCT07476794