Accelerated Radiation Therapy for Glioblastoma
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Mayo Clinic
Must not be taking: Carbidopa/levodopa
Disqualifiers: Pregnancy, Nursing, IDH mutation, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This phase II trial compares the effect of short course radiotherapy (RT) to standard course RT for the treatment of patients diagnosed with glioblastoma (GBM). The researchers want to learn whether the shorter course treatment is non-inferior (not worse than the standard of care), for patients with GBM. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Short course radiotherapy delivers higher doses of radiation over a shorter period of time and may kill more tumor cells and have fewer side effects.
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking carbidopa/levodopa, you must stop at least 48 hours before an 18F-DOPA-PET scan.
What data supports the effectiveness of Accelerated Hypofractionated Radiation Therapy for glioblastoma?
Research shows that hypofractionated radiation therapy, which involves giving larger doses of radiation over a shorter period, can be effective for glioblastoma, especially in elderly or frail patients. It has been found to be as effective as traditional longer courses of radiation, with the added benefit of a shorter treatment time.
12345Is accelerated radiation therapy safe for humans?
Accelerated radiation therapy, also known as hypofractionated radiation therapy, has been found to be a safe treatment option for glioblastoma patients, including those who are elderly or have other health challenges. While there is a risk of increased toxicity in some cases, studies have shown that most patients tolerate the treatment well, and it is considered a feasible option.
14678How is Accelerated Hypofractionated Radiation Therapy different from other treatments for glioblastoma?
Accelerated Hypofractionated Radiation Therapy is unique because it delivers higher doses of radiation over a shorter period, which can be more convenient for patients and may reduce treatment time without compromising effectiveness or increasing side effects compared to standard radiation therapy.
12349Eligibility Criteria
This trial is for adults over 18 with confirmed glioblastoma, able to complete questionnaires and have an ECOG performance status of 3 or less. Participants must consent in writing, be willing to follow up at the enrolling institution, and have a postoperative tumor size ≤6 cm. Excluded are those with IDH mutation tumors, MRI/18F-DOPA-PET scan issues, certain medication use, not receiving radiation at specified locations, or unwilling to use contraception.Inclusion Criteria
Ability to complete questionnaire(s) by themselves or with assistance
Provide written informed consent
My diagnosis of glioblastoma has been confirmed through testing.
+4 more
Exclusion Criteria
Unable to undergo an 18F-DOPA-PET scan
Unable to undergo MRI scans with contrast
I am not using or willing to use birth control.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Patients undergo either short course RT for 5-10 fractions over 1-2 weeks or standard course RT for 15-30 fractions over 3-6 weeks, with concurrent temozolomide administration
1-6 weeks
Multiple visits (in-person) for radiation therapy
Adjuvant Therapy
Patients receive temozolomide on days 1-5 every 28 days for up to 5-6 cycles post-radiation
5-6 months
Monthly visits (in-person or virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment
5 years
Every 2 months for the first year, every 3 months for the second year, every 4 months for the third year, then annually
Participant Groups
The SAGA Study is testing if short course radiotherapy (RT) can be as effective as standard RT for glioblastoma treatment. It involves higher doses over fewer sessions which may reduce side effects while targeting tumor cells more aggressively than conventional methods.
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (short course RT)Experimental Treatment9 Interventions
Patients undergo short course RT for 5-10 fractions over 1-2 weeks on study. Patients also receive temozolomide PO on days 1-5 every 28 days during radiation therapy. Starting one month post-radiation, patients continue temozolomide on days 1-5 every 28 days for up to 5 adjuvant cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT with 18-F-DOPA administered IV prior to RT on study, and undergo MRI prior to RT and throughout the trial. Patients may optionally undergo blood sample collection during screening and on the trial.
Group II: Arm B (standard course RT)Active Control9 Interventions
Patients undergo standard course RT for 15-30 fractions over 3-6 weeks on study. Patients also receive temozolomide PO QD concurrently with radiation therapy and for up to 6 adjuvant cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT with 18-F-DOPA administered IV prior to RT on study, and undergo MRI prior to RT and throughout the trial. Patients may optionally undergo blood sample collection during screening and on the trial.
Accelerated Hypofractionated Radiation Therapy is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Accelerated Hypofractionated Radiation Therapy for:
- Glioblastoma
🇪🇺 Approved in European Union as Accelerated Hypofractionated Radiation Therapy for:
- Glioblastoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic Radiation Therapy - NorthfieldNorthfield, MN
Mayo Clinic Health System in Albert LeaAlbert Lea, MN
Mayo Clinic Health Systems-MankatoMankato, MN
Mayo Clinic Health System-Eau ClaireEau Claire, WI
More Trial Locations
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
Identification of Patients With Glioblastoma Who May Benefit from Hypofractionated Radiotherapy. [2023]Standard radiotherapy (RT) for glioblastoma lasts 6 weeks. We aimed to identify patients who would benefit from a hypofractionated approach.
[Radiation therapy of adult cerebral glioblastoma:]. [2013]For the past twenty years, 85 adult patients with cerebral glioblastoma were treated with postoperative radiation therapy (RT). Hypofractionated RT (5 Gy twice a week) was performed in 31 patients. The survival rate of the hypofractionated RT was superior to the conventionally fractionated RT, especially in the patients involved mainly in the frontal lobe. In the hypofractionation group, misonidazole proved of benefit to the survival. In future, hyperfractionation of RT seems reasonable to be explored for improving CNS tolerance.
Hyperfractionated and accelerated-hyperfractionated radiotherapy for glioblastoma multiforme. [2022]Because of promising radiobiological advantages allowing dose escalation and/or reduction of treatment time, hyperfractionated and accelerated-hyperfractionated radiotherapy (hf-rt, ahf-rt) were introduced as part of treatment of glioblastoma multiforme (gbm). In December 1988 we started a prospective study of hf-rt (total dose 78 Gy, two daily fractions of 1.3 Gy, interval between daily fractions 6 hr, treatment time 6 weeks, n = 34 patients). The results were compared with our previous regimen of conventionally fractionated radiotherapy (cf-rt: total dose 60 Gy, single dose 2 Gy, treatment time 6 weeks, n = 32 patients). In June 1990, the protocol was modified in order to reduce treatment time (ahf-rt: total dose 60 Gy, two daily fractions of 1.5 Gy, interval 6 hr, treatment time 4 weeks, n = 92 patients until December 1996). No chemotherapy was given. Entry criteria were: age > or = 17 years, pathological diagnosis of supratentorial gbm, and no previous treatment other than surgery. The ahf-rt group included significantly more patients with previous surgical resection instead of biopsy only. Compared with the cf-rt group, both the hf-rt and the ahf-rt group included significantly more patients with frontal tumor location. We found no significant survival difference between the groups (median survival 7-10 months, 1-year survival rate 19%-29%). Progression-free survival, clinical course, and toxicity were also not significantly different. Karnofsky performance status, age, and corticosteroid dose during radiotherapy were the most important prognostic factors. The results of this trial are in large agreement with most previous publications. It demonstrated no improved survival. However, it showed that treatment time can be reduced by ahf-rt without loss of survival benefit or intolerable toxicity. A short radiotherapy course might be appropriate for many patients with gbm who are not suitable for rather aggressive investigational therapies.
Hypofractionated radiation therapy and temozolomide in patients with glioblastoma and poor prognostic factors. A prospective, single-institution experience. [2020]Hypofractionated radiation therapy is a feasible and safe treatment option in elderly and frail patients with glioblastoma. The aim of this study was to evaluate the effectiveness of hypofractionated radiation therapy with concurrent temozolomide in terms of feasibility and disease control in primary glioblastoma patients with poor prognostic factors other than advanced age, such as post-surgical neurological complications, high tumor burden, unresectable or multifocal lesions, and potential low treatment compliance due to social factors or rapidly progressive disease.
Hypo-fractionated Radiotherapy (HF-RT) Versus Conventionally Fractionated Radiotherapy (CF-RT) for Glioblastoma. [2023]Hypo-fractionated radiotherapy (HF-RT) is increasingly used for elderly and frail glioblastoma patients. In countries with limited radiotherapy capacities, HF-RT is more widely applied. This allowed us to compare conventional fractionation (CF-RT) vs. HF-RT in patients of any age and performance status.
[Hypofractionated radiotherapy for glioblastoma: changing the radiation treatment paradigm]. [2018]Hypofractionation has the dual advantage of increased cell death with a higher dose per fraction and a reduced effect of accelerated tumor cell repopulation due to a shorter overall treatment time. However, the potential advantage may be offset by increased toxicity in the late-responding neural tissues. Recently, investigators have attempted delivering radical doses of HFRT by escalating the dose in the immediate vicinity of the enhancing tumor and postoperative surgical cavity and reported reasonable outcomes with acceptable toxicity levels. Three different studies of high-dose HFRT have reported on the paradoxical phenomenon of improved survival in patients developing radiation necrosis at the primary tumor site. The toxicity criteria of RTOG and EORTC have defined clinically or radiographically suspected radionecrosis as Grade 4 toxicity. However, most patients diagnosed with radiation necrosis in the above studies remained asymptomatic. Furthermore, the probable association with improved survival would strongly argue against adopting a blind approach for classifying radiation necrosis as Grade 4 toxicity. The data emerging from the above studies is encouraging and strongly argues for further research. However, the majority of these studies are predominantly retrospective or relatively small single-arm prospective series that add little to the overall quality of evidence. Notwithstanding the above limitations, HFRT appears to be a safe and feasible strategy for glioblastoma patients.
Accelerated hyperfractionation plus temozolomide in glioblastoma. [2018]Hyperfractionated (HFRT) or accelerated hyperfractionated radiotherapy (AHFRT) have been discussed as a potential treatment for glioblastoma based on a hypothesized reduction of late radiation injury and prevention of repopulation. HFRT and AHFRT have been examined extensively in the pre-Temozolomide era with inconclusive results. In this study we examined the role of accelerated hyperfractionation in the Temozolomide era.
The use of hypofractionated intensity-modulated irradiation in the treatment of glioblastoma multiforme: preliminary results of a prospective trial. [2019]Despite major advances in treatment modalities, the prognosis of patients with glioblastoma multiforme (GBM) remains poor. Exploring hypofractionated regimens to replace the standard 6-week radiotherapy schedule is an attractive strategy as an attempt to prevent accelerated tumor cell repopulation. There is equally interest in dose escalation to the gross tumor volume where the majority of failures occur. We report our preliminary results using hypofractionated intensity-modulated accelerated radiotherapy regimen in the treatment of patients with GBM.
Moderately hypofractionated versus conventionally fractionated radiation therapy with temozolomide for young and fit patients with glioblastoma: an institutional experience and meta-analysis of literature. [2022]Shorter hypofractionated radiation therapy (HF-RT) schedules may have radiobiological, patient convenience and healthcare resource advantages over conventionally fractionated radiation therapy (CF-RT) in glioblastoma (GBM). We report outcomes of young, fit GBM patients treated with HF-RT and CF-RT during the COVID-19 pandemic, and a meta-analysis of HF-RT literature in this patient subgroup.