NCT07476794 Daily Temozolomide for Elderly Patients With Unmethylated MGMT- Promoter Newly Diagnosed GliOblatoma
| NCT ID | NCT07476794 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 118 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 118 participants in total. It began in 2025-11-01 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Frequently Asked Questions
Who can join the NCT07476794 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07476794 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07476794 currently recruiting?
Yes, NCT07476794 is actively recruiting participants. Visit ClinicalTrials.gov or contact Sunnybrook Health Sciences Centre to inquire about joining.
Where is the NCT07476794 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07476794 clinical trial?
NCT07476794 is sponsored by Sunnybrook Health Sciences Centre. The trial plans to enroll 118 participants.
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