ACTIVE_NOT_RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Stereotactic Accelerated Radiotherapy in GlioblastomA (SAGA)

Quick Facts

Study Start:2023-03-23
Study Completion:2028-07-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05781321

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>= 18 years
  2. * Histological and/or molecular confirmation of glioblastoma
  3. * Eastern Oncology Group (ECOG) performance status (PS) =\< 3
  4. * Ability to complete questionnaire(s) by themselves or with assistance
  5. * Provide written informed consent or have a legally authorized representative (LAR) who is responsible for the care and well-being of the potential study participant, provide consent
  6. * Willing to return to enrolling institution for follow-up either in-person or by video visit
  7. * 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
  1. * Unable to undergo MRI scans with contrast
  2. * Unable to undergo an 18F-DOPA-PET scan (e.g., Parkinson's Disease, taking carbidopa/levodopa and/or less than 48 hours from discontinuance)
  3. * Any of the following:
  4. * Pregnant women
  5. * Nursing women
  6. * Men or women of childbearing potential who are unwilling to employ adequate contraception
  7. * Tumors with IDH mutation
  8. * Previous brain radiation therapy
  9. * 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

Contacts and Locations

Principal Investigator

William G. Breen, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Roman O. Kowalchuk, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001
United States
Mayo Clinic Radiation Therapy - Northfield
Northfield, Minnesota, 55057
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
Mayo Clinic Health System-Eau Claire
Eau Claire, Wisconsin, 54701
United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-23
Study Completion Date2028-07-02

Study Record Updates

Study Start Date2023-03-23
Study Completion Date2028-07-02

Terms related to this study

Additional Relevant MeSH Terms

  • Glioblastoma