Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma (NCT06344130) | Clinical Trial Compass
RecruitingPhase 1
Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma
United States28 participantsStarted 2024-10-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Histologic diagnosis of primary glioblastoma or gliosarcoma of the brain, or secondary glioblastoma of the brain due to transformation from a lower grade to a grade 4 tumor.
* Age \>= 18.
* KPS \>= 70%.
* Previous tumor irradiation to curative-intent doses.
* Radiation dose constraints must be achievable based on assessment with MRI and treatment planning CT.
* Participants must have adequate organ and marrow function as defined below:
* Absolute neutrophil count (ANC) \>= 1,000/microL
* Platelets \>= 100,000/microL
* Individuals of child-bearing potential (IOCBP) and individuals who can father children must agree to use effective contraception (barrier, hormonal, intrauterine device, surgical sterilization, abstinence) from study entry and through 6 months after the last study treatment (restricted period). Individuals who can father children must not freeze or donate sperm within the same period.
* Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last study treatment.
* The ability of a participant to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
* Recent systemic therapy prior to the initiation of the study therapy as follows:
* Bevacizumab used for reasons other than tumor progression or symptomatic management within 2 weeks.
* Temozolomide within 2 weeks.
* Cytotoxic chemotherapy within 3 weeks.
* Any investigatio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MTD of daily re-irradiation in participants with recurrent grade 4 gliomas