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Protective VEGF Inhibition for Isotoxic Dose Escalation in Glioblastoma

ConditionGlioblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Hospital Tuebingen

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

IDH wild-type, MGMT unmethylated glioblastoma patients

Informed consent

Age ≥18 and ≤70 years, smoking or non-smoking, of any ethnic origin

ECOG 0-2

Disqualifiers

Evidence of significant hemorrhage on postoperative MRI of the brain. Patients with asymptomatic, minor hemosiderin deposition, resolving postsurgical hemorrhagic changes, or punctate intratumoral hemorrhage (e.g., related to biopsy or surgery) are not excluded

Subjects on any drug suspected to interfere with bevacizumab at the time of study inclusion

Immuno-compromised patients, including known seropositivity for human immunodeficiency virus (HIV)

Known hypersensitivity to any component of the investigational drugs or excipients (allergy to or other intolerability of bevacizumab or excipients)

Trial design

Design model

Single group

Treatments tested in this trial

  • Dose escalation of radiation dose beyond the therapeutic standard

    Radiation

    Dose escalation to 75 Gy with concomitant radioprotectant bevacizumab

Treatment groups

146 Participants
are divided into 1 treatment group
Group A: 75 Gy with two cycles of bevacizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

OS

Overall Survival

Time frame
Date of study inclusion (informed consent) to death or end of F/U

Secondary outcomes

1

Safety and tolerability

Safety and tolerability of dose escalation with bevacizumab according to CTCAE v5.0

Time frame
Date of study inclusion (informed consent) to death or end of F/U
2

PFS-6

6 months rate of progression-free survival

Time frame
6 months after the date of study inclusion (informed consent)
3

PFS

Progression-free survival

Time frame
Date of study inclusion (informed consent) to death or progression
4

QoL

Quality of life as determined by EORTC QLQ-C30/QLQ-BN 20

Time frame
Date of study inclusion (informed consent) to death or end of F/U

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Tuebingen

Lead sponsor

Source ClinicalTrials.gov
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