Study on Short Course Radiotherapy for Treating Glioblastoma: SAGA Study

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05781321

This clinical trial is comparing a shorter course of radiotherapy to the standard treatment for patients with glioblastoma, a type of brain cancer. The study aims to find out if the shorter treatment is just as effective and has fewer side effects.

Patient Parameters

Program Overview

This study is testing whether a shorter course of radiotherapy can be as effective as the standard treatment for glioblastoma, a type of brain cancer. Radiotherapy uses high-energy rays to kill cancer cells. The shorter course delivers higher doses over a shorter time, which might kill more cancer cells and cause fewer side effects.

Description

The main goal of this study is to see if patients with glioblastoma who receive a shorter, more intense course of radiotherapy live as long as those who receive the standard treatment. Researchers also want to check if the shorter treatment is safe and how it affects patients' quality of life.

Patients will be randomly assigned to one of two groups:

  • Group A: Will receive short course radiotherapy over 1-2 weeks, along with the drug temozolomide taken by mouth during and after radiation.
  • Group B: Will receive standard course radiotherapy over 3-6 weeks, with temozolomide taken daily during and after radiation.

All patients will have PET/CT and MRI scans to monitor the cancer. Blood samples may also be collected.

After treatment, patients will have follow-up visits every 2 months for the first year, every 3 months for the second year, and every 4 months for the third year. After 3 years, they will be checked at least once a year until 5 years after treatment.

Eligibility Criteria

Inclusion Criteria

  • Age 18 years or older
  • Confirmed diagnosis of glioblastoma
  • Able to perform daily activities with some help if needed
  • Able to complete questionnaires with or without help
  • Willing to provide written consent and return for follow-up visits
  • Tumor size after surgery or biopsy is 6 cm or smaller

Exclusion Criteria

  • Cannot have MRI scans with contrast
  • Cannot have 18F-DOPA-PET scans (e.g., due to Parkinson's Disease or certain medications)
  • Pregnant or nursing women, or those not using contraception
  • Tumors with a specific IDH mutation
  • Previous brain radiation therapy
  • Not receiving radiation treatment as part of the study

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