Radiation Therapy for Recurrent Brain Tumors
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but you cannot have had certain treatments like Bevacizumab, Temozolomide, or cytotoxic chemotherapy within 2-3 weeks before starting the study. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the treatment Hypofractionation Trial of Re-irradiation for recurrent brain tumors?
Research shows that hypofractionated stereotactic radiotherapy (HFSRT) and fractionated stereotactic radiotherapy (FSRT) are effective in treating recurrent malignant gliomas and brain metastases, providing a viable option for patients who have previously undergone radiation. These treatments help manage tumor growth and can reduce the need for additional surgeries.12345
Is radiation therapy for recurrent brain tumors safe?
Research shows that hypofractionated stereotactic radiotherapy (HFSRT) and hypofractionated radiosurgery (hfSRS) are generally safe for treating brain tumors, with side effects similar to those of single-fraction treatments. These methods have been used for various brain conditions, and studies suggest they have manageable toxicity levels.13567
How is the treatment Hypofractionation Trial of Re-irradiation different from other treatments for recurrent brain tumors?
This treatment uses hypofractionated stereotactic radiotherapy (HFSRT), which delivers radiation in larger doses over fewer sessions, making it a quicker option compared to traditional methods. It is designed to minimize the need for reoperation by reducing toxicity, unlike single-fraction stereotactic radiosurgery (SRS) and brachytherapy.12346
Research Team
Peter GK Mathen, M.D.
Principal Investigator
National Cancer Institute (NCI)
Eligibility Criteria
This trial is for adults over 18 with a type of brain cancer called grade 4 glioblastoma, which has returned after initial radiation therapy. Participants must have completed their first round of treatment and be in good enough health to undergo further radiation.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Re-irradiation Treatment
Participants undergo re-irradiation treatment 4 times per week for 1, 2, or 3 weeks, depending on the assigned dose level.
Follow-up
Participants are monitored for safety and effectiveness after treatment with follow-up visits 1 month after treatment, then every 2 months for 6 months, and every 3 months up to 3 years. Remote follow-up continues for an additional 2 years.
Treatment Details
Interventions
- Hypofractionation Trial of Re-irradiation (Radiation)
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Dr. Douglas R. Lowy
National Cancer Institute (NCI)
Chief Executive Officer since 2023
MD from New York University School of Medicine
Dr. Monica Bertagnolli
National Cancer Institute (NCI)
Chief Medical Officer since 2022
MD from Harvard Medical School