NCT07831772 · University of Minnesota
REMIND Maintenance Radiotherapy for Newly Diagnosed Glioblastoma
(REMIND)
What this study is about
REMIND is a single-center feasibility study testing maintenance radiotherapy in adult patients with newly diagnosed glioblastoma. Participants will be consented before starting standard-of-care concurrent temozolomide and radiotherapy. After enrollment, participants will enter an observational lead-in phase while receiving standard-of-care therapy off study.
View original scientific description
REMIND is a single-center feasibility study testing maintenance radiotherapy in adult patients with newly diagnosed glioblastoma. Participants will be consented before starting standard-of-care concurrent temozolomide and radiotherapy. After enrollment, participants will enter an observational lead-in phase while receiving standard-of-care therapy off study. Approximately 4 weeks after temozolomide, participants will receive one study-specific 2 Gy fraction of maintenance radiotherapy directed at the post-operative cavity and areas of prior enhancing disease. The study will evaluate the safety and feasibility of delivering maintenance radiotherapy. Blood samples will also be collected before and after maintenance radiotherapy to descriptively compare myeloid-derived suppressor cell frequency.
Interventions
RADIATION
Maintenance Radiotherapy
Maintenance radiotherapy consists of a single 2 Gy fraction of radiation delivered approximately 4 weeks after standard-of-care temozolomide. Intensity-modulated radiotherapy will be directed at the post-operative cavity and areas where previous enhancing disease was identified after surgical resection.
Primary outcome measures
Number and Percentage of Participants Who Complete the Single 2 Gy Fraction of Maintenance Radiotherapy
Time frame: From enrollment through completion of maintenance radiotherapy, approximately 4 weeks after standard-of-care temozolomide
Feasibility will be assessed by the number and percentage of enrolled participants who complete the study-specific single 2 Gy fraction of maintenance radiotherapy.
Occurrence of CTCAE Grade 4 or 5 Toxicities Related to the Single 2 Gy Maintenance Radiotherapy Fraction
Time frame: From maintenance radiotherapy through 28 days after study treatment
Safety will be assessed by the occurrence of CTCAE Grade 4 or 5 toxicities related to the experimental single 2 Gy maintenance radiotherapy fraction.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologically confirmed diagnosis of glioblastoma according to WHO classification criteria for which standard-of-care surgical resection, concurrent temozolomide and radiotherapy, and adjuvant temozolomide is planned
- Planning to receive standard-of-care radiotherapy with a biological effective dose of 60 Gy or less in 30 fractions
- Age 18 years or older at the time of consent
- Karnofsky performance status of 70 or higher
- Life expectancy of 3 months or longer
- Adequate organ function confirmed by laboratory values obtained within 14 days of study enrollment, defined as absolute neutrophil count at least 1.5 × 10\^9/L, platelets at least 50 × 10\^9/L, and hemoglobin at least 8 g/dL independent of transfusion within 14 days of screening
- Persons of childbearing potential or with partners of childbearing potential must be willing to use contraception during study treatment
- Concurrent use of other investigative treatment is permitted
- Voluntary written consent prior to the performance of any research-related activity
Exclusion criteria
- Pregnant or breastfeeding
- Presence of brain stem involvement within the planning target volume from the initial course of standard-of-care radiotherapy
- Prior radiation therapy to the brain
- Contraindication to MRI or CT
- Uncontrolled intercurrent illness, including ongoing or active infection, hypertension, serious cardiac arrhythmia requiring medication, acute cardiovascular disease or clinically manifested myocardial insufficiency, or psychiatric illness or social situations that would limit compliance with study requirements
- Any medical condition or clinical laboratory abnormality that, in the investigator's judgment, precludes safe participation in and completion of the study or could affect compliance with protocol conduct or interpretation of results
Where
- Minneapolis, Minnesota
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 21, 2026 · Source of record for eligibility and locations