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

Description

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

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Study Overview

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Study Details

Study overview

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.

Stereotactic Accelerated Radiotherapy in GlioblastomA (SAGA)

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

Condition
Glioblastoma
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Mayo Clinic in Arizona, Scottsdale, Arizona, United States, 85259

Jacksonville

Mayo Clinic in Florida, Jacksonville, Florida, United States, 32224-9980

Albert Lea

Mayo Clinic Health System in Albert Lea, Albert Lea, Minnesota, United States, 56007

Mankato

Mayo Clinic Health Systems-Mankato, Mankato, Minnesota, United States, 56001

Northfield

Mayo Clinic Radiation Therapy - Northfield, Northfield, Minnesota, United States, 55057

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Eau Claire

Mayo Clinic Health System-Eau Claire, Eau Claire, Wisconsin, United States, 54701

La Crosse

Mayo Clinic Health System-Franciscan Healthcare, La Crosse, Wisconsin, United States, 54601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age \>= 18 years
  • * Histological and/or molecular confirmation of glioblastoma
  • * Eastern Oncology Group (ECOG) performance status (PS) =\< 3
  • * Ability to complete questionnaire(s) by themselves or with assistance
  • * Provide written informed consent
  • * Willing to return to enrolling institution for follow-up either in-person or by video visit
  • * 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
  • * Unable to undergo MRI scans with contrast
  • * Unable to undergo an 18F-DOPA-PET scan (e.g., Parkinson's Disease, taking carbidopa/levodopa and/or less than 48 hours from discontinuance)
  • * Any of the following:
  • * Pregnant women
  • * Nursing women
  • * Men or women of childbearing potential who are unwilling to employ adequate contraception
  • * Tumors with IDH mutation
  • * Previous brain radiation therapy
  • * Patients who will not receive any radiation treatment or who will receive radiation treatment elsewhere (Note: radiotherapy can be given on the trial at Mayo Clinic facilities in Rochester, Arizona, or Florida, as well as at the Mayo Clinic Health System sites). Temozolomide, however, can be provided by another institution

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

William G. Breen, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Roman O. Kowalchuk, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

2028-03-02