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New hope for elderly brain cancer patients: modified chemo schedule shows promise

NCT ID NCT07476794

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 118 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

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

65 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, M4N3M5, Canada

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