Precision radiation boosts fight against deadly brain tumors
NCT ID NCT04574856
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether giving a higher, more targeted dose of radiation—guided by advanced MRI scans—along with standard chemotherapy (temozolomide) can improve survival in 30 people with newly diagnosed glioblastoma, an aggressive brain cancer. The radiation is adapted during treatment to hit the most resistant parts of the tumor. The main goal is to see if more people are alive at 12 months compared to usual care.
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 and dose-intensified radiotherapy
- What this could lead to
- If successful, this approach could extend survival for people with newly diagnosed glioblastoma by targeting treatment-resistant tumor areas more precisely.
- What could go wrong
- This is a small, early-phase study (30 participants) without a comparison group, so results may not apply broadly. The intensified radiation also carries risks of increased side effects.
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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30 people
The number who actually took part.
- Started
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Nov 2020
- Expected to finish
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Nov 2027
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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18 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: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Newly diagnosed, histologically-confirmed supratentorial WHO grade IV gliomas including glioblastoma (all variants) and gliosarcoma. Prior low-grade glioma without prior RT, now with malignant progression are eligible. * Karnofsky performance status \>=70 * Minimal life expectancy of 12 weeks * Adequate bone marrow reserve (Hemoglobin ≥ 10 g/dL, absolute neutrophils ≥ 1500/mm3, platelet count ≥ 100,000/mm3), acceptable liver function (total bilirubin ≤ 2 x upper limit of normal (ULN) (unless elevated bilirubin is related to Gilbert syndrome), and ALT/AST ≤ 5 x ULN) and renal function (serum creatinine ≤ 2.0 mg/dL) within 14 day prior to registration. Eligibility level for hemoglobin may be reached by transfusion. * Maximal contiguous diameter of tumor based on high b-value diffusion MRI and DCE perfusion MRI ≤5 cm * Patients must be registered within 6 weeks of most recent resection * Females of child-bearing potential must have a negative pregnancy test within 14 days prior to registration. Patients with reproductive potential must agree to use an effective contraceptive method during treatment and study participation. Exclusion Criteria: * Recurrent glioma, or tumor involving the brainstem or cerebellum * Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment is not permitted. Prior chemotherapy for a different cancer is allowable if interval since last treatment cycle completion is \>3 years. * Evidence of CSF dissemination (positive CSF cytology for malignancy or MRI findings consistent with CSF dissemination) * Evidence of severe concurrent disease requiring treatment * Prior invasive malignancy (except non-melanoma skin cancer or non-life limiting invasive malignancy that may not require treatment, such as low-risk prostate cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of breast, oral cavity or cervix are all permissible) * Patients unable to undergo MRI exams (i.e. patients with non-compatible devices such as cardiac pacemakers, other implanted electronic devices, metallic prostheses, or ferromagnetic prostheses \[e.g. pins in artificial joints and surgical pins/clips\], or unable to receive gadolinium for MRI, as per the standard Department of Radiology MRI screening criteria) * Patients treated with previous cranial or head/neck radiotherapy leading to significant radiation field overlap as determined by treating physician * Multifocal disease (\>1 lobe of involvement) of discontiguous contrast enhancing disease as seen on conventional MRI * Pregnancy or lactation
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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.
Contacts and locations
Locations
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University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
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Other studies related to the condition(s) this trial covers.
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