Actively Recruiting
Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma
Led by National Cancer Institute (NCI) · Updated on 2026-04-09
28
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy. Objective: To find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment. Eligibility: People aged 18 years and older with grade 4 GBM that returned after initial radiation treatment. Design: Participants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected. Participants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments. Participants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit. Participants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends. Participants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years.
CONDITIONS
Official Title
Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic diagnosis of primary glioblastoma or gliosarcoma of the brain, or secondary glioblastoma from lower grade tumor transformation
- Age 18 years or older
- Karnofsky performance scale (KPS) of 70% or higher
- Previous tumor irradiation to curative-intent doses
- Radiation dose constraints must be achievable based on MRI and treatment planning CT
- Adequate organ and marrow function with ANC >= 1,000/microL and platelets >= 100,000/microL
- Individuals able to use effective contraception from study entry through 6 months after last treatment
- Nursing participants willing to stop nursing from study treatment initiation through 6 months after last treatment
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Recent systemic therapy before study treatment: Bevacizumab within 2 weeks unless for tumor progression or symptoms
- Temozolomide within 2 weeks
- Cytotoxic chemotherapy within 3 weeks
- Any investigational agents within 2 weeks
- Unable to undergo MRI or receive gadolinium contrast
- Prior therapy after surgical re-resection or biopsy within 2 weeks
- Radiation therapy within 12 months prior to study treatment
- History of Novacure TTF, Gliadel wafers, or GammaTile therapy
- Positive pregnancy test in individuals of childbearing potential at screening
- Known or suspected radiation sensitivity syndromes
- Uncontrolled illnesses that increase risk to participant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
T
Theresa C Cooley Zgela, R.N.
CONTACT
P
Peter GK Mathen, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here