GliomaGliProPhNCT07750457
Proton vs. Photon Radiotherapy for Patients With WHO Grade 2-3 Glioma
A study testing Proton therapy and Photon therapy in people with Glioma, run by University Hospital, Essen at 2 sites in Germany.
Trial summary
Patients with grade 2 and 3 gliomas who received photon radiation therapy as part of their standard treatment are at risk of developing cognitive impairments, depending on the tumor's location and the size of the target volume. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Proton therapy and Photon therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesGermany
- Study dates
- 15 Jan 2019to 31 Dec 2033
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Histologically confirmed IDH-mutated WHO Grade 2 or 3 glioma with an indication for radiation therapy as determined by the local tumorboard at the study center
- 2. Tumor classification according to the 2021 WHO Classification, including the presence of the following markers:
- IDH1/2 mutation
- ATRX and/or 1p19q codeletion status
- CDKN2A/B codeletion status
- 3. A Karnofsky Performance Status of ≥ 70%
Show all 37Show fewer
- 4. Patients must be ≥ 18 years of age
- 5. Radiation therapy must begin within 7 weeks of surgery in patients with CNS WHO Grade 2 IDH-mutated gliomas. In individual cases, the start may be delayed, but not later than 10 weeks after surgery
- 6. For patients with WHO Grade 2 IDH-mutated CNS gliomas, the following applies:
- There is an indication for radiation therapy (partial tumor resection, age > 40 years, relevant neurological deficit)
- Enrollment in the study at the time of tumor progression is possible, even without a time constraint relative to the initial surgery, if the following criteria are met:
- There was initially no indication for radiation therapy
- At the time of tumor progression, there is an indication for radiation therapy as determined by the local tumor board
- At the time of recurrence, no repeat surgery is required to confirm the diagnosis if there is no imaging evidence of malignancy (see exclusion criterion No. 4)
- Radiation therapy must begin within 7 weeks after the recurrence MRI (or surgery, if a repeat surgery has been performed). In individual cases, treatment may begin later, but no later than 10 weeks after the recurrence MRI/surgery
- 7. For patients with WHO Grade 3 IDH-mutated CNS gliomas, radiation therapy must begin within 7 weeks after surgery . In individual cases, treatment may begin later, but no later than 10 weeks after surgery
- 8. At the time of study enrollment, the interval since the last surgery should be ≥ 2 weeks. Patients must have recovered from the effects of the surgery
- 9. The patient must consent and be able to undergo a neurocognitive baseline assessment prior to administration of the first radiation dose
- 10. The patient must provide written informed consent to participate in the study prior to enrollment
- 11. The study participant must be able to understand the purpose and implications of the study and must be willing to follow the clinical study instructions and, as far as can be anticipated, attend all scheduled study visits.
- 12. Women of childbearing potential must have a negative pregnancy test (serum or urine) that is no older than 7 days at the time of the first study intervention.
- 13. Laboratory values not older than 3 weeks prior to study enrollment: Absolute neutrophil count ≥ 1,500/mm³, Platelet count ≥ 100,000/mm³, Hemoglobin (Hb) level > 10 g/dL, Total bilirubin level ≤ 1.5 times the upper limit of normal, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 3 times the upper limit of normal, Creatinine level ≤ 1.5 times the upper limit of normal
- Exclusion Criteria Patients who meet any of the following criteria will not be enrolled in the study.
- General exclusion criteria:
- 1. Concurrent participation in another clinical interventional study or participation in a clinical study that requires administration of an investigational drug within 30 days prior to study enrollment.
- 2. A physical or mental condition of the patient that, in the judgment of the study physician, could endanger the patient, could bias the study results, or could negatively affect the patient's participation in the clinical trial.
- 3. Known or ongoing abuse of drugs, alcohol, or medications.
- Indication-specific exclusion criteria:
- 4. At the time of tumor recurrence in patients with WHO Grade 2 IDH-mutated CNS gliomas, there is evidence on MRI of malignancy (e.g., marked contrast enhancement indicating Grade 3-4).
- 5. Previous radiation therapy to the head or head and neck region
- 6. Previous chemotherapy due to a CNS neoplasm
- 7. Severe comorbidities that limit compliance with study requirements
- 8. Malignant invasive tumor disease with a tumor-free period of < 3 years
- 9. Evidence of leptomeningeal dissemination
- 10. Spinal or infratentorial tumor location
- 11. Patients with a known infection with the human immunodeficiency virus (HIV)
- 12. Patients with a newly diagnosed hepatitis infection or-at the discretion of the responsible study physician-a significant risk of reactivation
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Universitätsklinikum Essen
Essen
Christoph Oster, Dr. med., +492017230, neuroonkologie@uk-essen.de
Sied Kebir, PD Dr. med.
- Recruiting
Universitätsklinikum Gießen und Marburg
Giessen
Fabian Eberle, PD Dr. med., +4964215862950, Ambulanz.STT@uk-gm.de
Fabian Eberle, PD Dr. med.
About this study
Official title: Randomized Trial of Radiotherapy With Protons vs. Radiotherapy With Photons for Patients With WHO Grade 2-3 Glioma (GliProPh)
Patients with grade 2 and 3 gliomas who received photon radiation therapy as part of their standard treatment are at risk of developing cognitive impairments, depending on the tumor's location and the size of the target volume. The extent to which these are caused in individual cases by the brain tissue within the target volume, which is necessarily exposed to a high dose, or whether they can be modified by differences in the exposure of surrounding brain regions exposed to low or moderate doses, is unknown. With the help of proton therapy, the risk of neurocognitive dysfunction could potentially be reduced by decreasing the brain volumes outside the target volume that are exposed to radiation therapy and receive a low dose. Based on current knowledge of relative biological effectiveness, the efficacy of proton therapy on the tumor compared to photon therapy can be considered equivalent with lower levels of uncertainty. In the present study, the impact of photon irradiation versus proton irradiation on neurocognition will now be directly compared. A bicentric, randomized study will investigate whether treating patients with WHO Grade 2 and 3 gliomas with proton radiation results in a different temporal course of neurocognitive function after treatment compared to photon radiation therapy.
- Conditions
- Glioma
- Being tested
- Proton therapy, Photon therapy
- Keywords
- glioma, photon therapy, proton therapy, neurocognitive function
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton therapyRadiation
Grade 2 gliomas: 5 × 1.8 GyRBE to a total of 54 GyRBE
Grade 3 gliomas: 5 × 1.8 GyRBE to a total of 59.4 GyRBE (with concurrent chemotherapy) or 5 × 2.0 GyRBE to a total of 60 GyRBE
Photon therapyRadiation
Grade 2 gliomas: 5 × 1.8 GyRBE to a total of 54 GyRBE
Grade 3 gliomas: 5 × 1.8 GyRBE to a total of 59.4 GyRBE (with concurrent chemotherapy) or 5 × 2.0 GyRBE to a total of 60 GyRBE
| Study group | Role | What they receive |
|---|---|---|
| Photon therapy | Active comparator | Grade 2 gliomas: 5 × 1.8 GyRBE to a total of 54 GyRBE
Grade 3 gliomas: 5 × 1.8 GyRBE to a total of 59.4 GyRBE (with concurrent chemotherapy) or 5 × 2.0 GyRBE to a total of 60 GyRBE Receives: Radiation: Photon therapy |
| Proton therapy | Experimental | Grade 2 gliomas: 5 × 1.8 GyRBE to a total of 54 GyRBE
Grade 3 gliomas: 5 × 1.8 GyRBE to a total of 59.4 GyRBE (with concurrent chemotherapy) or 5 × 2.0 GyRBE to a total of 60 GyRBE Receives: Radiation: Proton therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognition
Composite Z-Score (Neurocognition) based on the cognitive domains assessed 3 years after completion of radiation therapy
Measured: three years after finishing radiotherapy
Secondary outcomes (9)
Neurocognition
Composite Z-Score (neurocognition) based on the assessed cognitive domains (see footnote: study protocol) at 4 weeks and
1, 2, 4, 5, and 6 years after completion of radiation therapy
Measured: 4 weeks and 1, 2, 4, 5, and 6 years after completion of radiation therapy
Decline of cognitive domains
A decline of > 1 SD from the baseline score in one of the cognitive domains studied when compared to the baseline assessment at 4 weeks and 1, 2, 3, 4, 5, and 6 years after completion of radiation therapy
Measured: At 4 weeks and 1, 2, 3, 4, 5, and 6 years after completion of radiation therapy
Quality of Life
Quality of Life According to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30; Version 3.0; Part A with 28 questions on a Likert scale, 28 to 112 points, Higher score means lower quality of life; Part B with 2 questions on a Likert scale, 2 to 14 points, Lower score means lower quality of life )
Measured: Pre radiation until 6 years after finishing radiotherapy
Quality of Life
Quality of Life According to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Brain Neoplasm 20 (20 questions on a Likert scale; 20 to 80 points; Higher score means lower quality of life)
Measured: Pre radiation until 6 years after finishing radiotherapy
Overall survival
Measured: From tumor diagnosis to death (usually 24 to 120 months)
Progression free survival
PFS
Measured: From date of first surgery until the date of first progression (MRI)
Progression free survival
PFS-6
Measured: Percentage of patients who are still progression-free six months after the date of their first surgery.
Adverse events
Incidence of Grade III-V adverse events according to CTCAE V5.0 up to the primary endpoint (3 years after completion of radiation therapy) or until disease progression
Measured: From pre radiation until progression or 3 years after completion of radiation therapy (whichever comes first)
Perilesional brain tissue changes
Frequency of perilesional brain tissue changes on follow-up MRI, classified by severity (Grades 1-4 (as defined by Fouladi 2004) at 4 weeks, 1, 2, 3, 4, 5, and 6 years after completion of radiation therapy
Measured: At 4 weeks, 1, 2, 3, 4, 5, and 6 years after completion of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start15 Jan 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized in two arms: Proton vs. photon therapy. Chemotherapy according to local standard (sequential temozolomide or procarbazine/CCNU).
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Giessen and Marburg
- Responsible party
- Principal investigator, Sied Kebir, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750457
- Sponsor's protocol ID
- EXT-201613_GliProPh
- Acronym
- GliProPh
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Radiotherapy With Protons vs. Radiotherapy With Photons for Patients With WHO Grade 2-3 Glioma (GliProPh)
- ClinicalTrials.gov ID
- NCT07750457
- Acronym / sponsor ID
- GliProPh / EXT-201613_GliProPh
- Conditions
- Glioma
- Keywords
- glioma, photon therapy, proton therapy, neurocognitive function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Collaborators
- University Hospital Giessen and Marburg
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 6 Aug 2026 (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.
Patients with grade 2 and 3 gliomas who received photon radiation therapy as part of their standard treatment are at risk of developing cognitive impairments, depending on the tumor's location and the size of the target volume. The extent to which these are caused in individual cases by the brain tissue within the target volume, which is necessarily exposed to a high dose, or whether they can be modified by differences in the exposure of surrounding brain regions exposed to low or moderate doses, is unknown. With the help of proton therapy, the risk of neurocognitive dysfunction could potentially be reduced by decreasing the brain volumes outside the target volume that are exposed to radiation therapy and receive a low dose. Based on current knowledge of relative biological effectiveness, the efficacy of proton therapy on the tumor compared to photon therapy can be considered equivalent with lower levels of uncertainty. In the present study, the impact of photon irradiation versus proton irradiation on neurocognition will now be directly compared. A bicentric, randomized study will investigate whether treating patients with WHO Grade 2 and 3 gliomas with proton radiation results in a different temporal course of neurocognitive function after treatment compared to photon radiation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized in two arms: Proton vs. photon therapy. Chemotherapy according to local standard (sequential temozolomide or procarbazine/CCNU).
| Arm | Type | Receives |
|---|---|---|
| Photon therapy | Active comparator | Radiation: Photon therapyGrade 2 gliomas: 5 × 1.8 GyRBE to a total of 54 GyRBE Grade 3 gliomas: 5 × 1.8 GyRBE to a total of 59.4 GyRBE (with concurrent chemotherapy) or 5 × 2.0 GyRBE to a total of 60 GyRBE |
| Proton therapy | Experimental | Radiation: Proton therapyGrade 2 gliomas: 5 × 1.8 GyRBE to a total of 54 GyRBE Grade 3 gliomas: 5 × 1.8 GyRBE to a total of 59.4 GyRBE (with concurrent chemotherapy) or 5 × 2.0 GyRBE to a total of 60 GyRBE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- 1. Histologically confirmed IDH-mutated WHO Grade 2 or 3 glioma with an indication for radiation therapy as determined by the local tumorboard at the study center
- 2. Tumor classification according to the 2021 WHO Classification, including the presence of the following markers:
- 3. A Karnofsky Performance Status of ≥ 70%
- 4. Patients must be ≥ 18 years of age
- 5. Radiation therapy must begin within 7 weeks of surgery in patients with CNS WHO Grade 2 IDH-mutated gliomas. In individual cases, the start may be delayed, but not later than 10 weeks after surgery
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Proton therapyGrade 2 gliomas: 5 × 1.8 GyRBE to a total of 54 GyRBE Grade 3 gliomas: 5 × 1.8 GyRBE to a total of 59.4 GyRBE (with concurrent chemotherapy) or 5 × 2.0 GyRBE to a total of 60 GyRBE | Radiation | Proton therapy |
| Photon therapyGrade 2 gliomas: 5 × 1.8 GyRBE to a total of 54 GyRBE Grade 3 gliomas: 5 × 1.8 GyRBE to a total of 59.4 GyRBE (with concurrent chemotherapy) or 5 × 2.0 GyRBE to a total of 60 GyRBE | Radiation | Photon therapy |
Primary outcome
Neurocognition
Time frame: three years after finishing radiotherapy
Composite Z-Score (Neurocognition) based on the cognitive domains assessed 3 years after completion of radiation therapy
9 secondary outcomes
Neurocognition
Time frame: 4 weeks and 1, 2, 4, 5, and 6 years after completion of radiation therapy
Decline of cognitive domains
Time frame: At 4 weeks and 1, 2, 3, 4, 5, and 6 years after completion of radiation therapy
Quality of Life
Time frame: Pre radiation until 6 years after finishing radiotherapy
Quality of Life
Time frame: Pre radiation until 6 years after finishing radiotherapy
Overall survival
Time frame: From tumor diagnosis to death (usually 24 to 120 months)
Progression free survival
Time frame: From date of first surgery until the date of first progression (MRI)
Progression free survival
Time frame: Percentage of patients who are still progression-free six months after the date of their first surgery.
Adverse events
Time frame: From pre radiation until progression or 3 years after completion of radiation therapy (whichever comes first)
Perilesional brain tissue changes
Time frame: At 4 weeks, 1, 2, 3, 4, 5, and 6 years after completion of radiation therapy
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 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton therapy and Photon therapy in people with Glioma, run by University Hospital, Essen at 2 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 37 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Contact Sied Kebir, PD Dr med. (+492017230, neuroonkologie@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognition (time frame: three years after finishing radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2026.