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.
What data supports the idea that Radiation Therapy for Recurrent Brain Tumors is an effective treatment?The available research shows that Radiation Therapy for Recurrent Brain Tumors, specifically using methods like Hypofractionated Stereotactic Radiotherapy (HFSRT) and Fractionated Stereotactic Radiotherapy (FSRT), is effective in treating recurrent malignant gliomas. One study involving 172 patients found that FSRT was effective for both low- and high-grade gliomas. Another study highlighted that HFSRT could be a good option for patients who have already received radiation, as it helps manage the tumor without needing more surgery. These studies suggest that this treatment can be a valuable option for patients with recurrent brain tumors.12346
Is the treatment Hypofractionation Trial of Re-irradiation promising for recurrent brain tumors?Yes, the treatment is promising. Hypofractionated stereotactic radiotherapy (HFSRT) and similar methods have shown to be effective for treating recurrent brain tumors, like gliomas and brain metastases. They offer a way to target tumors precisely, which can help reduce the need for more surgeries and manage the disease better.12356
What safety data exists for radiation therapy in recurrent brain tumors?The safety data for hypofractionated stereotactic radiotherapy (HFSRT) and related treatments like re-irradiation and stereotactic radiosurgery (SRS) indicate that these methods are being explored to increase efficacy while managing toxicity. Phase I and II trials have been conducted to evaluate the safety and side effects of HFSRT in recurrent malignant gliomas and brain metastases. These studies suggest that HFSRT can be a safe salvage treatment option, with toxicity levels comparable to single-fraction SRS, especially for lesions unsuitable for single-fraction treatment. Retrospective analyses also support the safety of hypofractionated approaches, showing comparable toxicity to single-fraction SRS for small lesions.12457
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you must stop taking your current medications. However, you cannot have had certain treatments like Bevacizumab, Temozolomide, cytotoxic chemotherapy, or investigational agents within 2-3 weeks before starting the trial. It's best to discuss your current medications with the trial team.
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.Treatment Details
The study is testing different schedules of re-irradiation (radiation therapy) on patients whose glioblastoma has recurred. The goal is to find the safest way to administer this treatment by varying the frequency and duration over one, two, or three weeks.
2Treatment groups
Experimental Treatment
Group I: 2/Arm 2Experimental Treatment1 Intervention
MTD of re-irradiation dose.
Group II: 1/Arm 1Experimental Treatment1 Intervention
Fraction size escalation of 3 planned re-irradiation dose levels.
Hypofractionation Trial of Re-irradiation is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Re-irradiation for:
- Recurrent glioblastoma multiforme (GBM)
🇺🇸 Approved in United States as Re-irradiation for:
- Recurrent glioblastoma multiforme (GBM)
Find a clinic near you
Research locations nearbySelect from list below to view details:
National Institutes of Health Clinical CenterBethesda, MD
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Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
References
A phase I dose escalation study of hypofractionated stereotactic radiotherapy as salvage therapy for persistent or recurrent malignant glioma. [2022]A phase I dose escalation of hypofractionated stereotactic radiotherapy (H-SRT) in recurrent or persistent malignant gliomas as a means of increasing the biologically effective dose and decreasing the high rate of reoperation due to toxicity associated with single-fraction stereotactic radiosurgery (SRS) and brachytherapy.
Hypofractionated stereotactic re-irradiation: treatment option in recurrent malignant glioma. [2022]Hypofractionated stereotactic radiotherapy (HFSRT) is one salvage treatment option in previously irradiated patients with recurrent malignant glioma. We analyzed the results of HFSRT and prognostic factors in a single-institution series.
Efficacy of fractionated stereotactic reirradiation in recurrent gliomas: long-term results in 172 patients treated in a single institution. [2022]To evaluate the efficacy of fractionated stereotactic radiotherapy (FSRT) performed as reirradiation in 172 patients with recurrent low- and high-grade gliomas.
Phase II trial of hypofractionated stereotactic radiotherapy for brain metastases: results and toxicity. [2022]To prospectively evaluate efficacy and side effects of hypofractionated stereotactic radiotherapy (hfSRT) for irresectable brain metastases not amenable to radiosurgery (SRS).
Hypofractionated stereotactic radiotherapy of limited brain metastases: a single-centre individualized treatment approach. [2022]We retrospectively report treatment results of our single-centre experience with hypofractionated stereotactic radiotherapy (hfSRT) of limited brain metastases in primary and recurrence disease situations. Our aim was to find the most effective and safe dose concept.
Stereotactic radiosurgery and stereotactic radiotherapy for brain metastases. [2022]Stereotactic radiosurgery (SRS) and hypofractionated stereotactic radiotherapy (HFSRT) have become important treatment modalities for brain metastases. While effective, there are still areas of extensive debate on its appropriate use in patients with life-limiting diseases. This review provides an overview of the indications and challenges of SRS and HFSRT in the management of brain metastases.
The use of Hypofractionated Radiosurgery for the Treatment of Intracranial Lesions Unsuitable for Single-Fraction Radiosurgery. [2019]Stereotactic radiosurgery (SRS) is commonly used in the treatment of brain metastases, benign tumors, and arteriovenous malformations (AVM). Single-fraction radiosurgery, though ubiquitous, is limited by lesion size and location. In these cases, hypofractionated radiosurgery (hfSRS) offers comparable efficacy and toxicity. We review the recent literature concerning hfSRS in the treatment of brain metastases, benign tumors, and AVMs that are poorly suited for single-fraction SRS. Published retrospective analyses suggest that local control rates for brain metastases and benign tumors, as well as the rates of AVM obliteration, following hfSRS treatment are comparable to those reported for single-fraction SRS. Additionally, the toxicities from hypofractionated treatment appear comparable to those seen with single-fractioned SRS to small lesions.