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Brain tumor study aims to clear up scans by shifting chemo timing

NCT ID NCT07439172

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests giving chemotherapy before radiation for people with high-grade gliomas, a type of aggressive brain tumor. The goal is to see if this approach works well and makes MRI scans easier to read, since radiation can change how the brain looks. About 70 adults aged 18-80 with measurable tumor after surgery will take temozolomide, the standard chemo, before starting radiation. This is a screening method to help test new drugs in the future.

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 70 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Sep 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

18 to 80 years

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: 1. Pathologic diagnosis of high-grade glioma 2. Residual measurable post-operative contrast enhancing tumor 3. Lack of urgency in requiring immediate radiation or chemotherapy (mass effect, mid-line shift, herniation, etc.) 4. Ability to provide informed consent 5. Willingness to comply with all study procedures and availability for the duration of the study 6. Male or female, aged 18-80. 7. Karnofsky Performance Status ³70%. 8. Patients must have the following organ and marrow functions: Absolute neutrophil count ≥1,500/µL Platelets ≥100,000/µL Hemoglobin ≥ 9 g/dL Total bilirubin £ 1.5 × institutional upper limit of normal (ULN), (except for patients with known Gilbert's syndrome who must have normal direct bilirubin) AST (SGOT)/ALT (SGPT) £ 2.5 × ULN Creatinine £ 1.5 × ULN OR Creatinine clearance ≥ 60 mL/min/1.73m2 APTT/PTT ≤ 1.5 × ULN Sodium ≥ the institutional lower limit of normal 9. Ability to take oral medication and be willing to adhere to the pre-radiation temozolomide regimen 10. For females of reproductive potential: use of highly effective contraception for at least 1 week prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of pr-radiation temozolomide administration 11. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner 12. Patients must have measurable disease as defined by RANO criteria. Exclusion Criteria: 1. Patients receiving any other investigational agents are ineligible. 2. Patients who had Gliadel wafer or other local therapy placed in the tumor cavity during the tumor resection. 3. Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to TMZ are ineligible. 4. Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible. 5. Pregnant women are excluded from this study because TMZ has potential for teratogenic or abortifacients effects. Breastfeeding should be discontinued if the mother is treated with TMZ.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The official record

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