Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study

• Status: Not yet recruiting
• Trial end date: 2028-03-02
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial compares the effect of short course radiotherapy (RT) to standard course RT for the treatment of patients diagnosed with glioblastoma (GBM). The researchers want to learn whether the shorter course treatment is non-inferior (not worse than the standard of care), for patients with GBM. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Short course radiotherapy delivers higher doses of radiation over a shorter period of time and may kill more tumor cells and have fewer side effects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Fluorides; Levodopa; Temozolomide

Criteria

Inclusion Criteria:

• Age >= 18 years

• Histological and/or molecular confirmation of glioblastoma

• Eastern Oncology Group (ECOG) performance status (PS) =< 3

• Ability to complete questionnaire(s) by themselves or with assistance

• Provide written informed consent

• Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

• Postoperative/post-biopsy tumor plus surgical bed size =< 6 cm in maximum diameter. This measurement includes both the enhancing region identified via T1 MRI with contrast, as well as the surgical cavity

Exclusion Criteria:

• Unable to undergo MRI scans with contrast

• Unable to undergo an 18F-DOPA-PET scan

• Concurrent use of anti-dopaminergic medications or dopamine agonists

• Any of the following:

• Pregnant women

• Nursing women

• Men or women of childbearing potential who are unwilling to employ adequate contraception

• Tumors with IDH mutation are excluded

• Patients who will not receive any radiation treatment or who will receive radiation treatment elsewhere (Note: radiotherapy can be given on the trial at Mayo Clinic facilities in Rochester, Arizona, or Florida, as well as at the Mayo Clinic Health System sites). Temozolomide, however, can be provided by another institution