Intensified Radiation Therapy for Brain Cancer
(ELITE-GBM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new radiation treatments for older adults with newly diagnosed glioblastoma, a type of brain cancer. Researchers aim to determine if higher doses of radiation over a shorter period (dose-escalated hypofractionation) are more effective and safe compared to the standard lower-dose radiation schedule (standard hypofractionated radiation). Participants will randomly receive either the standard or increased radiation treatment over three weeks. Suitable candidates have been diagnosed with glioblastoma within the last eight weeks and are age 65 or older. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must be on a stable or decreasing dose of corticosteroids for at least 14 days before joining. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that a new type of radiation therapy for brain cancer, called dose-escalated hypofractionated radiation therapy, is safe. Studies found that patients who received this treatment did not experience radiation-induced necrosis, a serious side effect where radiation damages brain tissue. This indicates the treatment is generally well-tolerated.
In these studies, patients with glioblastoma, a type of brain cancer, had a 50% overall response rate, meaning half responded well to the treatment. Additionally, 65% of patients were alive, and their disease had not worsened six months after treatment. These results surpass those of traditional treatments.
For those considering joining a trial, these findings offer reassurance about the safety of this new radiation therapy. While discussing potential risks with a healthcare provider is always important, current evidence suggests this treatment is safe.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the intensified radiation therapy for brain cancer because it uses dose-escalated hypofractionated radiation, which offers a more potent radiation dose over a shorter period compared to standard treatments. Unlike the typical approach that spreads radiation over many weeks, this method compresses the treatment into just three weeks, potentially increasing its effectiveness and convenience for patients. This intensified approach might also improve outcomes by delivering higher radiation doses directly to the tumor, potentially enhancing tumor control while minimizing damage to surrounding healthy tissue.
What evidence suggests that this trial's treatments could be effective for glioblastoma?
This trial will compare dose-escalated hypofractionated radiation therapy with standard hypofractionated radiation therapy for brain cancer. Research has shown that dose-escalated hypofractionated radiation therapy may extend the lives of older adults with glioblastoma. In some studies, patients who received this treatment lived for about 12 months on average. Approximately half of the patients responded well, and 65% did not experience disease progression after six months. This treatment has demonstrated good results compared to traditional methods. The side effects are generally manageable and not too severe for most patients.12367
Are You a Good Fit for This Trial?
This trial is for individuals aged 65 or older who have been newly diagnosed with a specific brain cancer called glioblastoma. They should be relatively active and able to care for themselves, with major organs functioning well. Participants must not have started treatment yet and should be within 8 weeks of their diagnosis.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either standard or dose-escalated hypofractionated radiation therapy over 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall survival and long-term outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Dose-escalated radiation therapy
- Standard hypofractionated radiation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor