REMIND Maintenance Radiotherapy for Newly Diagnosed Glioblastoma

NCT07831772 | Recruiting

• 1 other identifier: 2024LS207
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Keywords

REMIND; Maintenance radiotherapy; Radiotherapy; Temozolomide

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From maintenance radiotherapy through 28 days after study treatment

Secondary Outcomes (1)

• Change in Peripheral Blood Myeloid-Derived Suppressor Cell Frequency

  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.

Other Outcomes (1)

• Percentage Change in Peripheral Blood Myeloid-Derived Suppressor Cell Frequency After Maintenance Radiotherapy

  Within 2 weeks before maintenance radiotherapy and within 1 week after maintenance radiotherapy

Study Arms (1)

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.

Radiation: Maintenance Radiotherapy

Interventions

Maintenance Radiotherapy RADIATION

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

Maintenance Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Radiation Oncology

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Lindsey Sloan, MD, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsey Sloan

CONTACT

612-273-6700; radoncresearch@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 21, 2026
• Study Start: August 24, 2026
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): September 20, 2028
• Last Updated: September 21, 2026

Record last verified: 2026-09

Locations

US (1)