MR-Guided Adaptive Radiotherapy + Temozolomide for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a new approach to radiation therapy, combined with the chemotherapy drug Temozolomide, can extend survival for individuals with glioblastoma, an aggressive brain cancer. The trial targets more precise radiation delivery to difficult-to-treat tumor areas, aiming to improve survival compared to standard treatments. It seeks participants recently diagnosed with glioblastoma who have not yet undergone radiation. Those diagnosed with this type of brain cancer, without spread to areas like the brainstem, may find this trial suitable. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
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. Please consult with the study team for guidance.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that temozolomide (TMZ) is generally safe for treating glioblastoma, a type of brain cancer. Studies indicate that TMZ can help patients, including older ones, live longer. However, some individuals might experience blood-related side effects, such as anemia or low white blood cell counts.
The dose-intensified radiotherapy is currently in a Phase 2 trial, which means researchers are still studying its safety. Phase 2 trials have suggested some safety in earlier research, but more information is needed to fully understand its effects.
In summary, TMZ has a strong safety record, while the intensified radiotherapy is still under investigation for its safety in humans.12345Why are researchers excited about this study treatment for glioblastoma?
Researchers are excited about dose-intensified radiotherapy for glioblastoma because it combines advanced imaging and targeted radiation in a way that current treatment options do not. Unlike standard therapies that use fixed radiation plans, this approach is adaptive, meaning it can adjust to changes in the tumor's size and shape in real-time, guided by MRI. This precision aims to maximize the radiation dose to the cancer cells while minimizing damage to surrounding healthy tissue, potentially improving outcomes and reducing side effects.
What evidence suggests that dose-intensified radiotherapy and temozolomide could be effective for glioblastoma?
Research shows that adding temozolomide to radiation therapy helps glioblastoma patients live longer. Studies have found that this combination increases the average survival time compared to using radiation alone. Specifically, one study revealed that 70% of patients who received both treatments were alive after 10 years, compared to 47% of those who only had radiation. Additionally, using temozolomide for a longer period has been linked to better survival without causing more severe side effects. In this trial, patients will receive dose-intensified, adaptive photon radiation therapy. Although research on MR-guided adaptive radiotherapy is still developing, this method aims to more accurately target high-risk tumor areas, potentially enhancing treatment effectiveness.13467
Who Is on the Research Team?
Michelle Kim, MD
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for adults with newly diagnosed glioblastoma who can give informed consent, follow study procedures, and have a life expectancy of at least 12 weeks. They should be in good physical condition (Karnofsky score ≥70), have adequate organ function, and agree to use contraception if applicable. The tumor must be ≤5 cm in diameter and patients must enroll within 6 weeks post-surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants receive dose-intensified, adaptive photon radiation therapy
Chemotherapy
Concurrent administration of Temozolomide with radiation therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall survival and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Dose-Intensified Radiotherapy
- Temozolomide
Dose-Intensified Radiotherapy is already approved in United States, European Union for the following indications:
- Glioblastoma
- Anaplastic astrocytomas
- Glioblastoma
- Anaplastic astrocytomas
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor