New hope for elderly brain cancer patients: modified chemo schedule shows promise
NCT ID NCT07476794
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is for people aged 65 and older with a newly diagnosed, aggressive brain cancer called glioblastoma that has a specific genetic marker (unmethylated MGMT) making standard treatment less effective. Researchers are testing a different way of giving the chemotherapy drug temozolomide after radiation, giving it daily for 5 days every 28 days for up to 6 cycles. The goal is to see if this modified schedule can help patients live longer and slow the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- temozolomide (chemotherapy)
- What this could lead to
- If successful, this modified dosing schedule could offer a better way to slow tumor growth and extend survival for elderly patients with this hard-to-treat brain cancer.
- What could go wrong
- This is a small, early-phase trial (118 participants) testing a different schedule of an existing drug, so the benefit may be modest. Side effects from chemotherapy remain a risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 118 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sunnybrook Health Sciences Centre
RECRUITINGToronto, Ontario, M4N3M5, Canada
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