RecruitingPhase 1NCT06344130

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

A Phase I Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma


Sponsor

National Cancer Institute (NCI)

Enrollment

28 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study tests a shortened course of re-irradiation (fewer, larger doses of radiation — called hypofractionation) in patients with glioblastoma (a serious brain cancer) that has come back after previous radiation treatment, and who still have a good functional status. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of glioblastoma or gliosarcoma (including grade 4 tumors that transformed from lower grade brain tumors) - You had previous radiation therapy for your brain tumor - Your general functional status is good (Karnofsky score of 70% or above) - Your blood counts are adequate - You are willing to use effective contraception if applicable **You may NOT be eligible if...** - Your blood counts or organ function are too low to safely receive radiation - Radiation dose limits to critical brain structures cannot be safely met - You are currently breastfeeding and unwilling to stop - You are unable to understand or sign the consent form Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiation Therapy

Radiation therapy will be administered via a linear accelerator using 6 megavoltage (MV) photons or greater.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT06344130


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