Maintenance radiotherapy after standard glioblastoma treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

REMIND is a single-center, investigator-initiated feasibility study in adults with newly diagnosed glioblastoma. After consenting to standard-of-care temozolomide and radiotherapy, participants enter an observational lead-in phase with routine care data collection. About four weeks after completing temozolomide, participants receive one 2 Gy fraction of maintenance radiotherapy targeted to the post-operative cavity and prior enhancing areas, using intensity-modulated radiotherapy. The primary goal is to assess safety and feasibility of delivering this maintenance dose, with descriptive analysis of immune cell changes in blood pre- and post-radiotherapy. Active data collection occurs during standard treatment before maintenance therapy begins.

Why it matters

Who can join: the full rules

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 it's running

• University of Minnesota Radiation Oncology
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Lindsey Sloan, MD, PhD — University of Minnesota
• Study coordinator: Lindsey Sloan
• Email: radoncresearch@umn.edu
• Phone: 612-273-6700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.