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Radiation Therapy

Accelerated Radiation Therapy for Glioblastoma

Phase 2

Recruiting

Led By Roman O. Kowalchuk, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients alive [overall survival (OS)] at 12 months

Secondary study objectives

Lymphocyte count

Proportion of patients whose radiation oncologist reported a grade 3+ toxicity

Quality of life: EORTC QLQ-BN20

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 prior to RT and 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 prior to RT and 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

Temozolomide

2010

Completed Phase 3

~1880

Positron Emission Tomography

2011

Completed Phase 2

~2200