Personalized Radiation Therapy for Glioblastoma

Overseen By Michelle Alonso-Basanta, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Disqualifiers: Gliadel wafers, Other malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Personalized Radiation Therapy for Glioblastoma?

Research suggests that using advanced radiation techniques like hypofractionated radiotherapy and stereotactic radiosurgery can help improve local control of glioblastoma, which may lead to better outcomes. Additionally, combining full-dose external beam radiotherapy with other methods like brachytherapy or radiosurgery boosts has shown an increase in median survival for selected patients. ^{1 2 3 4 5}

Is Personalized Radiation Therapy safe for humans?

Research on different forms of radiation therapy for glioblastoma, like stereotactic radiosurgery and hypofractionated radiotherapy, suggests that while these treatments aim to improve outcomes, they also focus on maintaining quality of life and limiting side effects. However, the safety and effectiveness can vary, and it's important to discuss potential risks with your healthcare provider. ^{1 6 7 8 9}

How is Personalized Radiation Therapy different from other treatments for glioblastoma?

Personalized Radiation Therapy for glioblastoma is unique because it uses lower doses of radiation tailored to the individual, aiming to reduce damage to healthy brain tissue while still effectively targeting the tumor. This approach contrasts with standard treatments that use higher, uniform doses, which can lead to more side effects without improving survival. ^{2 8 10 11 12}

What is the purpose of this trial?

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.

Research Team

Michelle Alonso-Basanta

Principal Investigator

Abramson Cancer Center at Penn Medicine

Eligibility Criteria

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.

Inclusion Criteria

Ability to give signed informed consent

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

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

Exclusion Criteria

Participation in another investigational trial

I am currently being treated for another cancer.

I have had Gliadel wafers placed in my brain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive personalized dose-escalated radiation therapy

6-8 weeks

Follow-up

Participants are monitored for safety, toxicity, patterns of recurrence, and overall survival

12 months

Treatment Details

Interventions

• Personalized Radiation Therapy

Trial Overview 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.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

Dose-escalated radiation therapy

Personalized Radiation Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Personalized Radiation Therapy for:

• HPV-positive throat cancer

Approved in European Union as De-escalated Radiation Therapy for:

• HPV-positive oropharyngeal squamous cell carcinoma

Who Is Running the Clinical Trial?

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Findings from Research

Fractionated stereotactic re-irradiation shows a 12-month overall survival rate of 33.1% and a progression-free survival rate of 13.4% in patients with recurrent glioblastoma, based on a meta-analysis of eight studies involving 307 patients.

The treatment has a low incidence of radiation necrosis, indicating it is a relatively safe option for patients, with factors like age and radiation dose affecting survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractionated stereotactic re-irradiation for recurrent glioblastoma: A systematic review and meta-analysis. Luo, T., Feng, J., Sun, P.[2023]

Recent advances in radiation therapy for malignant glioma, such as stereotactic radiotherapy and charged particle therapy, aim to improve treatment efficacy while reducing damage to healthy tissues.

Combining these advanced radiation techniques with targeted biochemotherapies may enhance therapeutic outcomes for patients with malignant glioma, which has historically had a poor prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted radiotherapy for malignant gliomas. Oh, DS., Adamson, DC., Kirkpatrick, JP.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Stereotactic Radiosurgery and Hypofractionated Radiotherapy for Glioblastoma. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[Radiotherapy of glioblastoma]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Dose Escalated Radiation Therapy for Glioblastoma Multiforme: An International Systematic Review and Meta-Analysis of 22 Prospective Trials. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Novel radiation technologies for malignant gliomas. [2019]

5. Ireland pubmed.ncbi.nlm.nih.gov

Study protocol: PreOperative Brain Irradiation in Glioblastoma (POBIG) - A phase I trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Reevaluating stereotactic radiosurgery for glioblastoma: new potential for targeted dose-escalation. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Fractionated stereotactic re-irradiation for recurrent glioblastoma: A systematic review and meta-analysis. [2023]

8. Ireland pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy in newly diagnosed glioblastoma: a systematic review on clinical and technical issues. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

[Radiobiological problems in the radiotherapy of brain tumors (author's transl)]. [2006]

10. United States pubmed.ncbi.nlm.nih.gov

Radiation therapy of glioblastoma. [2018]

11. England pubmed.ncbi.nlm.nih.gov

External beam re-irradiation, combination chemoradiotherapy, and particle therapy for the treatment of recurrent glioblastoma. [2022]

12. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Targeted radiotherapy for malignant gliomas. [2019]