GlioblastomaPhase 2PRIDENCT05871021
Protective VEGF Inhibition for Isotoxic Dose Escalation in Glioblastoma
A Phase 2 study testing Dose escalation of radiation dose beyond the therapeutic standard in people with Glioblastoma, run by University Hospital Tuebingen at 9 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Dose escalation of radiation dose beyond the therapeutic standard
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 9 sitesGermany
- Study dates
- 10 Apr 2024to 15 Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Neutrophil counts >1500/µl, Platelet counts >100.000/µl, Hemoglobin > 8 g/dl, Serum creatinine <1.5-fold upper limit of normal (ULN), Bilirubin, AST or ALT <2.5-fold ULN unless attributed to anticonvulsants, Alkaline phosphatase <2.5-fold ULN
- Adequate contraception
- Serum creatinine ≤ 1.5 x ULN AND patients with urine dipstick for proteinuria < 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should show urine protein to creatinine ratio ≤ 1
Who cannot join
- 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)
- Any other significant medical illness or medically significant laboratory finding that would, in the investigator's judgement, make the patient inappropriate for this study, or would increase the risk associated with the patients' participation in the study
- Incapability to undergo MRI
Show all 19Show fewer
- Prior treatment with bevacizumab for any indication
- Contraindication and/or hypersensitivity to bevacizumab or its excipients. For details check the Summary of Product Characteristics Aybintio®
- Significant cardiovascular disease defined as congestive heart failure (NYHA Class II, III, IV), unstable angina pectoris, or myocardial infarction within 6 months prior to enrolment
- Inadequately controlled hypertension (defined as a blood pressure of > 150 mmHg systolic and/or >100 mmHg diastolic on medication), or any prior history of hypertensive crisis or hypertensive encephalopathy
- History of clinically significant cerebrovascular events within 6 months prior to enrolment. This includes ischemic stroke or transient ischemic attack. Small, clinically silent perioperative ischemic changes are not exclusionary.
- Significant vascular disease (e.g. aortic aneurysm, aortic dissection or recent peripheral arterial thrombosis) within 6 months prior to enrolment
- Evidence or history of recurrent thromboembolism (> 1 episode of deep venous thrombosis / peripheral embolism) during the past 2 years
- Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
- Chronic daily intake of aspirin > 325 mg/day or clopidogrel > 75 mg /day
- History of intracranial abscess within 6 months prior to inclusion
- History of abdominal or tracheo-oesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrolment
- History of ≥ grade 2 hemoptysis according to NCI-CTC criteria within 1 month prior to inclusion
- Serious non-healing wound, ulcer or bone fracture
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Department of Radiation Oncology, University Hospital Augsburg
Augsburg
Department of Radiation Oncology, University Hospital Köln
Cologne
Department of Radiation Oncology, University Hospital Frankfurt
Frankfurt
Department of Radiation Oncology, University Hospital Freiburg
Freiburg im Breisgau
Department of Radiation Oncology, University Hospital Leipzig
Leipzig
Department of Radiation Oncology, Medical Faculty Mannheim
Mannheim
Department of Radiation Oncology, University Hospital, LMU Munich
Munich
Department of Neurology, University Hospital Regensburg
Regensburg
Department of Radiation Oncology
Tübingen, 72076
About this study
Official title: A Phase IIb, 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
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.
- Conditions
- Glioblastoma
- Being tested
- Dose escalation of radiation dose beyond the therapeutic standard
- Keywords
- Dose escalation, bevacizumab, VEGF inhibition, FET PET, VMAT
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose escalation of radiation dose beyond the therapeutic standardRadiation
Also called bevacizumab
Dose escalation to 75 Gy with concomitant radioprotectant bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| 75 Gy with two cycles of bevacizumab | Experimental | Not described Receives: Radiation: Dose escalation of radiation dose beyond the therapeutic standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall Survival
Measured: Date of study inclusion (informed consent) to death or end of F/U
Secondary outcomes (6)
Safety and tolerability
Safety and tolerability of dose escalation with bevacizumab according to CTCAE v5.0
Measured: Date of study inclusion (informed consent) to death or end of F/U
PFS-6
6 months rate of progression-free survival
Measured: 6 months after the date of study inclusion (informed consent)
PFS
Progression-free survival
Measured: Date of study inclusion (informed consent) to death or progression
QoL
Quality of life as determined by EORTC QLQ-C30/QLQ-BN 20
Measured: Date of study inclusion (informed consent) to death or end of F/U
Cognitive function
Cognitive function determined by standard test batteries
Measured: Date of study inclusion (informed consent) to death or end of F/U
Exploratory objective
Validation of prognostic 4-miRNA signature-based risk score
Measured: Date of study inclusion (informed consent) to death or end of F/U
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start10 Apr 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion15 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maximilian Niyazi, Prof. Dr., Principal investigator, University Hospital Tuebingen, Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871021
- Sponsor's protocol ID
- 2021-000565-32
- Acronym
- PRIDE
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2023
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maier SH, Schonecker S, Anagnostatou V, Garny S, Nitschmann A, Fleischmann DF, Buttner M, Kaul D, Imhoff D, Fokas E, Seidel C, Hau P, Kolbl O, Popp I, Grosu AL, Haussmann J, Budach W, Celik E, Kahl KH, Hoffmann E, Tabatabai G, Paulsen F, Holzgreve A, Albert NL, Mansmann U, Corradini S, Belka C, Niyazi M, Bodensohn R. Dummy run for planning of isotoxic dose-escalated radiation therapy for glioblastoma used in the PRIDE trial (NOA-28; ARO-2024-01; AG-NRO-06). Clin Transl Radiat Oncol. 2024 May 4;47:100790. doi: 10.1016/j.ctro.2024.100790. eCollection 2024 Jul.
PubMed 38765202
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, 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
- ClinicalTrials.gov ID
- NCT05871021
- Acronym / sponsor ID
- PRIDE / 2021-000565-32
- Conditions
- Glioblastoma
- Keywords
- Dose escalation, bevacizumab, VEGF inhibition, FET PET, VMAT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 15 Apr 2029 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 75 Gy with two cycles of bevacizumab | Experimental | Radiation: Dose escalation of radiation dose beyond the therapeutic standard |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Neutrophil counts >1500/µl, Platelet counts >100.000/µl, Hemoglobin > 8 g/dl, Serum creatinine <1.5-fold upper limit of normal (ULN), Bilirubin, AST or ALT <2.5-fold ULN unless attributed to anticonvulsants, Alkaline phosphatase <2.5-fold ULN
Key exclusion criteria (19 listed)
- 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)
- Any other significant medical illness or medically significant laboratory finding that would, in the investigator's judgement, make the patient inappropriate for this study, or would increase the risk associated with the patients' participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose escalation of radiation dose beyond the therapeutic standardAlso: bevacizumabDose escalation to 75 Gy with concomitant radioprotectant bevacizumab | Radiation | 75 Gy with two cycles of bevacizumab |
Primary outcome
OS
Time frame: Date of study inclusion (informed consent) to death or end of F/U
Overall Survival
6 secondary outcomes
Safety and tolerability
Time frame: Date of study inclusion (informed consent) to death or end of F/U
PFS-6
Time frame: 6 months after the date of study inclusion (informed consent)
PFS
Time frame: Date of study inclusion (informed consent) to death or progression
QoL
Time frame: Date of study inclusion (informed consent) to death or end of F/U
Cognitive function
Time frame: Date of study inclusion (informed consent) to death or end of F/U
Exploratory objective
Time frame: Date of study inclusion (informed consent) to death or end of F/U
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Derived from this study: PubMed 38765202Maier SH, Schonecker S, Anagnostatou V, Garny S, Nitschmann A, Fleischmann DF, Buttner M, Kaul D, Imhoff D, Fokas E, Seidel C, Hau P, Kolbl O, Popp I, Grosu AL, Haussmann J, Budach W, Celik E, Kahl KH, Hoffmann E, Tabatabai G, Paulsen F, Holzgreve A, Albert NL, Mansmann U, Corradini S, Belka C, Niyazi M, Bodensohn R. Dummy run for planning of isotoxic dose-escalated radiation therapy for glioblastoma used in the PRIDE trial (NOA-28; ARO-2024-01; AG-NRO-06). Clin Transl Radiat Oncol. 2024 May 4;47:100790. doi: 10.1016/j.ctro.2024.100790. eCollection 2024 Jul.
- Dosimetric feasibility analysis and presentation of an isotoxic dose-escalated radiation therapy concept for glioblastoma used in the PRIDE trialLink provided by the sponsor.
- Dummy run for planning of isotoxic dose-escalated radiation therapy for glioblastoma used in the PRIDE trial (NOA-28; ARO-2024-01; AG-NRO-06)Link provided by the sponsor.
- FET PET-based target volume delineation for the radiotherapy of glioblastoma: A pictorial guide to help overcome methodological pitfallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maximilian Niyazi, Prof. Dr. principal investigator
University Hospital Tuebingen, Department of Radiation Oncology
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dose escalation of radiation dose beyond the therapeutic standard in people with Glioblastoma, run by University Hospital Tuebingen at 9 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: Date of study inclusion (informed consent) to death or end of F/U). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05871021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.