REMIND Maintenance Radiotherapy for Newly Diagnosed Glioblastoma

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.

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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (1)

• University of Minnesota Radiation Oncology, Minneapolis, Minnesota · Recruiting