What side effects are associated with this type of intervention?

The most common treatments for Glioblastoma, such as radiation therapy and chemoradiation with temozolomide, are associated with several side effects. Radiation therapy can cause fatigue, hair loss, skin changes, and cognitive deficits, particularly when higher doses are used. Chemoradiation with temozolomide may add side effects like nausea, vomiting, loss of appetite, and increased risk of infection due to bone marrow suppression. Personalized dose-escalation radiation therapy aims to tailor the radiation dose to individual patients, potentially increasing the risk of these side effects but also aiming to improve progression-free survival.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma, including the use of radiation therapy and the chemotherapy drug temozolomide. Standard treatment often involves surgical resection followed by radiation therapy and concurrent temozolomide, which has been shown to improve survival. Additionally, the Optune device, which uses tumor-treating fields, has been approved for use in combination with temozolomide. Personalized dose-escalation radiation therapy, as studied in recent trials, aims to tailor radiation doses to individual patients to potentially improve progression-free survival, building on the established use of radiation in Glioblastoma treatment.

What other types of research exist?

Promising novel alternatives to Personalized Dose-Escalation Radiation Therapy for Glioblastoma patients include: 1) Targeted therapies such as Bevacizumab combined with Temozolomide, which have shown efficacy in recurrent gliomas. 2) Immunotherapy approaches, including checkpoint inhibitors and CAR-T cell therapy, which are being actively researched for their potential to improve outcomes. 3) Advanced radiation techniques like Proton Craniospinal Irradiation, which may offer better targeting of tumors with reduced side effects. These alternatives are being explored for their potential to improve progression-free survival and overall outcomes in Glioblastoma patients.

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Radiation Therapy

Personalized Radiation Therapy for Glioblastoma

N/A

Waitlist Available

Led By Robert Lustig, MD

Research Sponsored by Abramson Cancer Center of the University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or older

Karnofsky Performance Status (KPS) at least 70

Must not have

Active treatment of another malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if giving customized higher doses of radiation can help patients with aggressive brain cancer live longer without their disease getting worse. The study will also look at side effects and overall survival.

Who is the study for?

This trial is for adults over 18 with a confirmed diagnosis of WHO Grade IV glioblastoma who have had most of their tumor surgically removed and are set to receive chemoradiation. Participants must be able to consent and have a Karnofsky Performance Status (KPS) score of at least 70, indicating they can care for themselves.

What is being tested?

The study tests personalized dose-escalation radiation therapy in glioblastoma patients. It aims to see how well it works by looking at the time before the cancer worsens, side effects, where and when the cancer might come back, and overall survival rates.

What are the potential side effects?

While specific side effects aren't listed here, radiation therapy can generally cause fatigue, skin reactions in treated areas, headaches or swelling due to brain inflammation, nausea or vomiting. Long-term effects may include memory loss or cognitive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am able to care for myself but may not be able to do active work.

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I have a high-grade brain tumor and am receiving chemotherapy and radiation after surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for another cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Dose-escalated radiation therapy

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Glioblastoma treatments typically involve surgery, radiation therapy, and chemotherapy. Surgery aims to remove the tumor bulk, while radiation therapy, including personalized dose-escalation, targets residual cancer cells with high-energy rays to prevent recurrence. Chemotherapy, often using temozolomide, damages cancer cell DNA to inhibit replication. Personalized dose-escalation radiation therapy is crucial as it customizes the radiation dose to individual patients, potentially enhancing progression-free survival by more precisely targeting tumor cells and sparing healthy tissue.