Recruiting

Maintenance Radiotherapy

Sponsor:

University of Minnesota

Code:

NCT07831772

Conditions

Glioblastoma

Newly Diagnosed Glioblastoma

Brain Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Maintenance Radiotherapy

Study Details

Brief 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. 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.

Conditions

Glioblastoma

Newly Diagnosed Glioblastoma

Brain Tumor

Study ID

NCT07831772

Start date

Aug 24, 2026

Status verified date

Sep, 2026

Completion date

Sep 20, 2028

Anticipated

Primary completion date

Sep 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

4 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Maintenance Radiotherapy

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.

Interventions

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 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Lindsey Sloan

612-273-6700radoncresearch@umn.edu

Locations

University of Minnesota Radiation Oncology

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Lindsey Sloan, MD, PhD

612-273-6700radoncresearch@umn.edu

Principal Investigator:

Lindsey Sloan, MD, PhD

More Information

Sponsor

University of Minnesota

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Keywords

  • REMIND
  • Maintenance radiotherapy
  • Radiotherapy
  • Temozolomide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.