Short course radiotherapy for glioblastoma treatment
Stereotactic Accelerated Radiotherapy in GlioblastomA (SAGA)
This study is testing whether a shorter course of radiotherapy is just as effective as the standard treatment for people with glioblastoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation |
| Locations | 8 sites (Scottsdale, Arizona and 7 other locations) |
| Trial ID | NCT05781321 on ClinicalTrials.gov |
What this trial studies
This phase II trial compares the effectiveness of short course radiotherapy to standard course radiotherapy in patients diagnosed with glioblastoma. The primary goal is to demonstrate that the shorter treatment duration is not worse than the standard care in terms of overall survival at 12 months. Secondary objectives include assessing the safety of the treatment, exploring patient-reported outcomes related to quality of life, and analyzing the impact on the immune system and treatment-related lymphopenia. The study also aims to evaluate the cost-effectiveness of the new treatment regimen.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically or molecularly confirmed glioblastoma and an ECOG performance status of 3 or lower.
Not a fit: Patients who are unable to undergo MRI or PET scans, or those who are pregnant or nursing, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide glioblastoma patients with a more effective treatment option that may lead to improved survival and quality of life.
How similar studies have performed: Other studies have shown promising results with hypofractionated radiotherapy approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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 or have a legally authorized representative (LAR) who is responsible for the care and well-being of the potential study participant, provide consent * Willing to return to enrolling institution for follow-up either in-person or by video visit * 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 (e.g., Parkinson's Disease, taking carbidopa/levodopa and/or less than 48 hours from discontinuance) * 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 * Previous brain radiation therapy * 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
Where this trial is running
Scottsdale, Arizona and 7 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Active_not_recruiting)
- Mayo Clinic Health System in Albert Lea — Albert Lea, Minnesota, United States (Recruiting)
- Mayo Clinic Health Systems-Mankato — Mankato, Minnesota, United States (Recruiting)
- Mayo Clinic Radiation Therapy - Northfield — Northfield, Minnesota, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
- Mayo Clinic Health System-Eau Claire — Eau Claire, Wisconsin, United States (Recruiting)
- Mayo Clinic Health System-Franciscan Healthcare — La Crosse, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: William G. Breen, MD — Mayo Clinic in Rochester
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.