← Back to Search

Radiation Therapy

Accelerated Radiation Therapy for Glioblastoma

Phase 2
Recruiting
Led By William G. Breen, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histological and/or molecular confirmation of glioblastoma
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to 3 years
Awards & highlights

Study Summary

This trial will compare a shorter course of radiation therapy to the standard of care for brain cancer patients. It hopes to find a more effective treatment with fewer side effects.

Who is the study for?
This trial is for adults over 18 with confirmed glioblastoma, able to complete questionnaires and have an ECOG performance status of 3 or less. Participants must consent in writing, be willing to follow up at the enrolling institution, and have a postoperative tumor size ≤6 cm. Excluded are those with IDH mutation tumors, MRI/18F-DOPA-PET scan issues, certain medication use, not receiving radiation at specified locations, or unwilling to use contraception.Check my eligibility
What is being tested?
The SAGA Study is testing if short course radiotherapy (RT) can be as effective as standard RT for glioblastoma treatment. It involves higher doses over fewer sessions which may reduce side effects while targeting tumor cells more aggressively than conventional methods.See study design
What are the potential side effects?
Potential side effects from accelerated hypofractionated radiation therapy could include skin irritation at the treatment site, fatigue, headaches, nausea and potential cognitive changes due to high-dose exposure in a short timeframe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My diagnosis of glioblastoma has been confirmed through testing.
Select...
My tumor and surgery area are less than 6 cm wide combined.
Select...
I am 18 years old or older.
Select...
I can take care of myself but may not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients alive (overall survival [OS]) at 12 months
Secondary outcome measures
Lymphocyte count
Proportion of patients whose physician reported a grade 3+ toxicity
Quality of life: EORTC QLQ-BN20 Questionnaire
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (short course RT)Experimental Treatment9 Interventions
Patients undergo short course RT for 5-10 fractions over 1-2 weeks on study. Patients also receive temozolomide PO on days 1-5 every 28 days during radiation therapy. Starting one month post-radiation, patients continue temozolomide on days 1-5 every 28 days for up to 5 adjuvant cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT with 18-F-DOPA administered IV prior to RT on study, and undergo MRI throughout the trial. Patients may optionally undergo blood sample collection during screening and on the trial.
Group II: Arm B (standard course RT)Active Control9 Interventions
Patients undergo standard course RT for 15-30 fractions over 3-6 weeks on study. Patients also receive temozolomide PO QD concurrently with radiation therapy and for up to 6 adjuvant cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT with 18-F-DOPA administered IV prior to RT on study, and undergo MRI throughout the trial. Patients may optionally undergo blood sample collection during screening and on the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1920
Positron Emission Tomography
2008
Completed Phase 2
~2260
Temozolomide
2010
Completed Phase 3
~1930
Fluorodopa F 18
2019
Completed Phase 2
~50
Computed Tomography
2017
Completed Phase 2
~2790
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,190 Previous Clinical Trials
3,758,931 Total Patients Enrolled
14 Trials studying Glioblastoma
629 Patients Enrolled for Glioblastoma
William G. Breen, M.D.Principal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
20 Total Patients Enrolled
William G BreenPrincipal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Accelerated Hypofractionated Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05781321 — Phase 2
Glioblastoma Research Study Groups: Arm B (standard course RT), Arm A (short course RT)
Glioblastoma Clinical Trial 2023: Accelerated Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT05781321 — Phase 2
Accelerated Hypofractionated Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05781321 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial currently recruiting participants?

"Per information held on clinicaltrials.gov, the aforementioned medical trial is no longer searching for patients. Initially posted in March 27th 2023, with its last update dated March 19th 23rd; however 458 other studies are still recruiting participants as of now."

Answered by AI

Does the Food and Drug Administration recognize Arm A (short course RT) as being an acceptable therapeutic approach?

"Our team at Power has ascribed a score of 2 to Arm A (short course RT) on the basis that this is Phase 2 trial, which implies there are some data suggesting safety but no evidence supporting efficacy."

Answered by AI
~113 spots leftby Mar 2027