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

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.

Conditions

• Glioblastoma

Interventions

OTHER

Questionnaire Administration

Complete questionnaires

RADIATION

Radiation Therapy

Undergo standard course RT

DRUG

Temozolomide

Given PO

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET

OTHER

Quality-of-Life Assessment

Ancillary studies

RADIATION

Accelerated Hypofractionated Radiation Therapy

Undergo short course RT

PROCEDURE

Computed Tomography

Undergo CT simulation

DRUG

Fluorodopa F 18

Given IV

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• William G. Breen, MD · Mayo Clinic in Rochester

• Roman O. Kowalchuk, MD · Mayo Clinic in Rochester

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-23

Primary Completion

2026-07-02

Completion

2028-07-02

FDA Drug

Yes

Countries

• United States

Study Locations