RecruitingPhase 2NCT05871021

Protective VEGF Inhibition for Isotoxic Dose Escalation in Glioblastoma

A Phase IIa, Open-label, Multicenter Study of Radiochemotherapy With Isotoxic Dose Escalation and Protective VEGF Inhibition Using Bevacizumab in the Treatment of Patients With First Diagnosis of IDH Wild-type, MGMT Unmethylated Glioblastoma


Sponsor

University Hospital Tuebingen

Enrollment

146 participants

Start Date

Apr 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Glioblastoma is the most aggressive brain tumor and often recurs locally despite intensive treatment. Standard chemoradiotherapy with 60 Gy may not be sufficient to control the tumor, and dose escalation seems to be warranted, but causes more toxicity. To address this, the multicentric PRIDE trial employs two cycles of bevacizumab to achieve dose escalation isotoxically. The goal is improved survival without significantly increasing side effects. The study uses a simultaneous integrated boost with a total dose of 75 Gy in 2.5 Gy per fraction.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug that blocks tumour blood vessel growth (a VEGF inhibitor) can allow doctors to safely deliver higher doses of radiation to glioblastoma — the most aggressive form of brain cancer — while reducing damage to surrounding healthy brain tissue. **You may be eligible if...** - You have been diagnosed with IDH wild-type, MGMT unmethylated glioblastoma (a specific type of aggressive brain tumour) - You are between 18 and 70 years old - Your overall health is good enough (ECOG 0–2) - Your blood counts and organ function are adequate **You may NOT be eligible if...** - Your glioblastoma has different genetic features (IDH-mutant or MGMT-methylated) - You have significant kidney problems or high levels of protein in your urine - You are not able to use adequate contraception - You have certain blood-clotting disorders or uncontrolled high blood pressure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONDose escalation of radiation dose beyond the therapeutic standard

Dose escalation to 75 Gy with concomitant radioprotectant bevacizumab


Locations(9)

Department of Radiation Oncology, University Hospital Augsburg

Augsburg, Germany

Department of Radiation Oncology, University Hospital Köln

Cologne, Germany

Department of Radiation Oncology, University Hospital Frankfurt

Frankfurt, Germany

Department of Radiation Oncology, University Hospital Freiburg

Freiburg im Breisgau, Germany

Department of Radiation Oncology, University Hospital Leipzig

Leipzig, Germany

Department of Radiation Oncology, Medical Faculty Mannheim

Mannheim, Germany

Department of Radiation Oncology, University Hospital, LMU Munich

Munich, Germany

Department of Neurology, University Hospital Regensburg

Regensburg, Germany

Department of Radiation Oncology

Tübingen, Germany

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NCT05871021


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