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Glioblastoma is an aggressive type of brain cancer. Standard treatment usually includes three weeks of radiation therapy alone or combined with chemotherapy using Temozolomide. After a four- to six-week break, more Temozolomide chemotherapy is usually given. However, some tumors have a marker ("unmethylated MGMT") that predicts the usual chemotherapy won't work. Because of this, this project will explore other treatment options to help slow the disease and improve survival. In this study, the same chemotherapy (Temozolomide) normally given after radiation therapy for glioblastoma. The only difference is that it will be given with a modified regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Daily TMZ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily TMZ | Drug | Following completion of radiation therapy, temozolomide will be administered daily for 5 days each of a 28-day cycle, for a maximum of 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | How long the participant survives following initial diagnosis | From initial diagnosis until date of death from any cause (assessed up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | From initial diagnosis until disease progression | From initial diagnosis until disease progression (assessed up to 24 months) |
| Toxicities | The side effects that participants experience while on study treatment |
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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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N3M5 | Canada |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| From treatment start through study completion (estimated up to 5 years) |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |