An interventional study of Maintenance Radiotherapy in Glioblastoma, Newly Diagnosed Glioblastoma and Brain Tumor, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
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.
Also known as: 2 Gy Maintenance RT
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.
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
Safety will be assessed by the occurrence of CTCAE Grade 4 or 5 toxicities related to the experimental single 2 Gy maintenance radiotherapy fraction.
Time frame: From maintenance radiotherapy through 28 days after study treatment
Change in Peripheral Blood Myeloid-Derived Suppressor Cell Frequency
Within 2 weeks before maintenance radiotherapy and within 1 week after maintenance radiotherapy
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.
Percentage Change in Peripheral Blood Myeloid-Derived Suppressor Cell Frequency After Maintenance Radiotherapy
The frequency of myeloid-derived suppressor cells in peripheral blood will be measured within 2 weeks before maintenance radiotherapy and within 1 week after maintenance radiotherapy. The percentage change from pre-maintenance radiotherapy will be recorded for each participant.
Time frame: Within 2 weeks before maintenance radiotherapy and within 1 week after maintenance radiotherapy
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