GlioblastomaREMINDNCT07831772
REMIND Maintenance Radiotherapy for Newly Diagnosed Glioblastoma
A study testing Maintenance Radiotherapy in people with Glioblastoma and Newly Diagnosed Glioblastoma, run by University of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Newly Diagnosed Glioblastoma, Brain Tumor
- What is being tested?
- Maintenance Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2026to 20 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota Radiation Oncology
Minneapolis, Minnesota, 55455
Lindsey Sloan, MD, PhD, 612-273-6700, radoncresearch@umn.edu
Lindsey Sloan, MD, PhD
About this study
Official title: REMIND: An Investigator Initiated Study Testing the Feasibility of Maintenance Radiotherapy for Patients With Newly Diagnosed Glioblastoma
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.
Read the detailed description
Glioblastoma is an aggressive primary brain tumor with high rates of local recurrence despite standard treatment with surgical resection, concurrent temozolomide and radiotherapy, and adjuvant temozolomide. This study is designed to test whether an additional single fraction of maintenance radiotherapy can be delivered safely and feasibly after standard-of-care treatment.
REMIND is a single-center investigator-initiated study enrolling adult patients with newly diagnosed glioblastoma. Eligible participants will be consented before starting standard-of-care concurrent temozolomide and radiotherapy. Following enrollment, participants will enter an observational lead-in phase while receiving their prescribed standard-of-care therapy off study. During this lead-in phase, study data collection will be limited to routine electronic medical record abstraction to confirm standard-of-care treatment administration and monitor basic clinical status.
Active study participation begins approximately 2 weeks after standard-of-care treatment, when participants undergo simulation for maintenance radiotherapy. Approximately 4 weeks after temozolomide, participants will receive maintenance radiotherapy consisting of one 2 Gy fraction delivered using intensity-modulated radiotherapy directed at the post-operative cavity and areas where previous enhancing disease was identified after surgical resection.
The primary objective is to test the safety and feasibility of delivering maintenance radiotherapy. Safety will be evaluated by monitoring toxicities and adverse events, including Grade 4 or 5 toxicities related to the experimental 2 Gy radiotherapy fraction. Feasibility will be evaluated based on treatment completion. The secondary objective is to descriptively compare the frequency of myeloid-derived suppressor cells in peripheral blood before and after maintenance radiotherapy. Participants will be followed for disease response per standard of care every 2 to 4 months until death or for up to 5 years from maintenance radiotherapy.
- Conditions
- Glioblastoma, Newly Diagnosed Glioblastoma, Brain Tumor
- Being tested
- Maintenance Radiotherapy
- Keywords
- REMIND, Maintenance radiotherapy, Radiotherapy, Temozolomide
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintenance RadiotherapyRadiation
Also called 2 Gy Maintenance RT
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.
| Study group | Role | What they receive |
|---|---|---|
| Maintenance Radiotherapy | Experimental | Participants with newly diagnosed glioblastoma will receive standard-of-care therapy off study during an observational lead-in phase, followed by one study-specific 2 Gy fraction of maintenance radiotherapy approximately 4 weeks after temozolomide. Receives: Radiation: Maintenance Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Participants Who Complete the Single 2 Gy Fraction of Maintenance Radiotherapy
Feasibility will be assessed by the number and percentage of enrolled participants who complete the study-specific single 2 Gy fraction of maintenance radiotherapy.
Measured: From enrollment through completion of maintenance radiotherapy, approximately 4 weeks after standard-of-care temozolomide
Occurrence of CTCAE Grade 4 or 5 Toxicities Related to the Single 2 Gy Maintenance Radiotherapy Fraction
Safety will be assessed by the occurrence of CTCAE Grade 4 or 5 toxicities related to the experimental single 2 Gy maintenance radiotherapy fraction.
Measured: From maintenance radiotherapy through 28 days after study treatment
Secondary outcomes (1)
Change in Peripheral Blood Myeloid-Derived Suppressor Cell Frequency
Within 2 weeks before maintenance radiotherapy and within 1 week after maintenance radiotherapy
Measured: The frequency of myeloid-derived suppressor cells in peripheral blood will be descriptively compared before and after maintenance radiotherapy. The percentage change from pre-maintenance radiotherapy will be recorded for each participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start24 Aug 2026
- Primary completion20 Sep 2027 (estimated)
- Study completion20 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Eligible participants with newly diagnosed glioblastoma will receive standard-of-care surgical resection, concurrent temozolomide and radiotherapy, and adjuvant temozolomide off study during an observational lead-in phase. 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.
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lindsey Sloan, MD, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831772
- Sponsor's protocol ID
- 2024LS207
- Acronym
- REMIND
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REMIND: An Investigator Initiated Study Testing the Feasibility of Maintenance Radiotherapy for Patients With Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT07831772
- Acronym / sponsor ID
- REMIND / 2024LS207
- Conditions
- Glioblastoma, Newly Diagnosed Glioblastoma, Brain Tumor
- Keywords
- REMIND, Maintenance radiotherapy, Radiotherapy, Temozolomide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- 20 Sep 2027 (estimated)
- Study completion
- 20 Sep 2028 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Glioblastoma is an aggressive primary brain tumor with high rates of local recurrence despite standard treatment with surgical resection, concurrent temozolomide and radiotherapy, and adjuvant temozolomide. This study is designed to test whether an additional single fraction of maintenance radiotherapy can be delivered safely and feasibly after standard-of-care treatment.
REMIND is a single-center investigator-initiated study enrolling adult patients with newly diagnosed glioblastoma. Eligible participants will be consented before starting standard-of-care concurrent temozolomide and radiotherapy. Following enrollment, participants will enter an observational lead-in phase while receiving their prescribed standard-of-care therapy off study. During this lead-in phase, study data collection will be limited to routine electronic medical record abstraction to confirm standard-of-care treatment administration and monitor basic clinical status.
Active study participation begins approximately 2 weeks after standard-of-care treatment, when participants undergo simulation for maintenance radiotherapy. Approximately 4 weeks after temozolomide, participants will receive maintenance radiotherapy consisting of one 2 Gy fraction delivered using intensity-modulated radiotherapy directed at the post-operative cavity and areas where previous enhancing disease was identified after surgical resection.
The primary objective is to test the safety and feasibility of delivering maintenance radiotherapy. Safety will be evaluated by monitoring toxicities and adverse events, including Grade 4 or 5 toxicities related to the experimental 2 Gy radiotherapy fraction. Feasibility will be evaluated based on treatment completion. The secondary objective is to descriptively compare the frequency of myeloid-derived suppressor cells in peripheral blood before and after maintenance radiotherapy. Participants will be followed for disease response per standard of care every 2 to 4 months until death or for up to 5 years from maintenance radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Eligible participants with newly diagnosed glioblastoma will receive standard-of-care surgical resection, concurrent temozolomide and radiotherapy, and adjuvant temozolomide off study during an observational lead-in phase. 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.
| Arm | Type | Receives |
|---|---|---|
| Maintenance Radiotherapy | Experimental | Radiation: Maintenance RadiotherapyParticipants with newly diagnosed glioblastoma will receive standard-of-care therapy off study during an observational lead-in phase, followed by one study-specific 2 Gy fraction of maintenance radiotherapy approximately 4 weeks after temozolomide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maintenance RadiotherapyAlso: 2 Gy Maintenance RTMaintenance 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. | Radiation | Maintenance Radiotherapy |
Primary outcome
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.
1 secondary outcome
Change in Peripheral Blood Myeloid-Derived Suppressor Cell Frequency
Time frame: The frequency of myeloid-derived suppressor cells in peripheral blood will be descriptively compared before and after maintenance radiotherapy. The percentage change from pre-maintenance radiotherapy will be recorded for each participant.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lindsey Sloan, MD, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maintenance Radiotherapy in people with Glioblastoma and Newly Diagnosed Glioblastoma, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsey Sloan (612-273-6700, radoncresearch@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.