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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 belowSelect...
My diagnosis of glioblastoma has been confirmed through testing.
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My tumor and surgery area are less than 6 cm wide combined.
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I am 18 years old or older.
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I can take care of myself but may not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 3 years
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diagnosis of glioblastoma has been confirmed through testing.My tumor and surgery area are less than 6 cm wide combined.I am not using or willing to use birth control.I am currently breastfeeding.I can take care of myself but may not be able to do heavy physical work.I am currently taking medication that affects dopamine levels.My tumor does not have an IDH mutation.I am 18 years old or older.I will not have radiation or will get it outside of Mayo Clinic, except for Temozolomide.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (standard course RT)
- Group 2: Arm A (short course RT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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