GlioblastomaGRIPSNCT04752280
Glioblastoma Radiotherapy Using IMRT or Proton Beams
A study testing Proton irradiation and Photon irradiation in people with Glioblastoma, run by University Hospital Heidelberg at 3 sites in Germany.
Trial summary
Radiation therapy is an integral part of the multimodal primary therapy of glioblastomas. As the overall prognosis in this tumor entity remains unfavorable, current research is focused on additional drug therapies, which are often accompanied by increases in toxicity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Proton irradiation and Photon irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 3 sitesGermany
- Study dates
- 19 Apr 2021to 19 Jan 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
- histologically confirmed gliomblastoma WHO IV (operated or after biopsy)
- Indication for radiotherapy / radiochemotherapy
- Informed consent
- KI ≥ 60% or ECOG 0/1
- Age ≥ 18 years
- Sufficient effective contraception
Who cannot join
- Patient is not able to consent
- Previous radiotherapy in the brain or skull base
- Active medical implants for which there is no ion radiation authorization at the time of treatment (e.g., cardiac pacemaker, defibrillator, ...)
- Contraindication to MRI imaging
- Simultaneous participation in another clinical trial that could influence the outcome of this study or other study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Klaus Herfarth, Prof. Dr. contact
Germany3 sites, 3 recruiting
- Recruiting
Universitätsklinikum Heidelberg
Heidelberg
Klaus Herfarth, Prof. Dr.
- Not yet recruiting
Universitätsklinikum Gießen und Marburg
Marburg
Rita Engenhart-Cabillic, Prof. Dr.
- Not yet recruiting
Klinikum Stuttgart
Stuttgart
Marc Münter, Prof. Dr.
About this study
Radiation therapy is an integral part of the multimodal primary therapy of glioblastomas. As the overall prognosis in this tumor entity remains unfavorable, current research is focused on additional drug therapies, which are often accompanied by increases in toxicity. By using proton beams instead of photon beams, it is possible to protect large parts of the brain which are not affected by the tumor more effectively. An initial retrospective matched-pair analysis showed that this theoretical physical benefit is also clinically associated with a reduction in toxicity during therapy and in the first few months thereafter. The aim of the GRIPS study is to prospectively test this clinical benefit in a randomized, open-label Phase III study. Patients are treated in the study using either modern photon radiation techniques (standard arm) or proton beams (experimental arm). The primary endpoint is the cumulative toxicity CTC grade 2 and higher in the first 4 months. Secondary endpoints include overall survival, progression-free survival, quality of life, and neurocognition.
- Conditions
- Glioblastoma
- Being tested
- Proton irradiation, Photon irradiation
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton irradiationRadiation
proton irradiation applied as follows: 30 x 2 Gy(RBE) 33 x 1,8 Gy (RBE), or 15 x 2,67 Gy (RBE)
Photon irradiationRadiation
proton irradiation applied as follows: 30 x 2 Gy 33 x 1,8 Gy, or 15 x 2,67 Gy
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Proton irradiation | Experimental | Irradiation applied with protons Receives: Radiation: Proton irradiation |
| Arm B: Photon IMRT | Active comparator | Photon irradiation applied as intensity-modulated radiotherapy Receives: Radiation: Photon irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative rate of toxicity
Cumulative rate of toxicity ≥ grade 2 (until progress (max. month 4))
Measured: from start of radiotherapy until progress (max. month 4)
Secondary outcomes (8)
Progression free survival
Progression free survival
Measured: 1 year and 2 years
Overall survival
Overall survival
Measured: 1 year and 2 years
Acute Toxicity
according to CTC AE V5.0
Measured: start of therapy until 6 weeks after end of therapy (end of therapy up to month 4)
Late Toxicity
according to CTC AE V5.0
Measured: 6 weeks after end of therapy (end of therapy up to month 4)
Quality of life according to EORTC QLQ-C30
according to EORTC QLQ-C30
Measured: 1 year and 2 years
Quality of life according to EORTC QLQ-BN20
according to EORTC QLQ-BN20
Measured: 1 year and 2 years
Neurocognition
according to Hopkins Verbal Learning Test-Revised
Measured: 1 year and 2 years
Measuring number of Lymphocytes count
Measured: end of therapy up to month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start19 Apr 2021
- Primary completion19 Sep 2030 (estimated)
- Study completion19 Jan 2033 (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 HeidelbergThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Debus, University Hospital Heidelberg
- Investigators
- Laila König, Prof. Dr., Principal investigator, University Hospital of Heidelberg, Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752280
- Sponsor's protocol ID
- GRIPS
- Acronym
- GRIPS
- Status last verified
- May 2026
- First submitted
- 9 Feb 2021
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Konig L, Jakel C, von Knebel Doeberitz N, Kieser M, Eberle F, Munter M, Debus J, Herfarth K. Glioblastoma radiotherapy using Intensity modulated Radiotherapy (IMRT) or proton Radiotherapy-GRIPS Trial (Glioblastoma Radiotherapy via IMRT or Proton BeamS): a study protocol for a multicenter, prospective, open-label, randomized, two-arm, phase III study. Radiat Oncol. 2021 Dec 20;16(1):240. doi: 10.1186/s13014-021-01962-8.
PubMed 34930368
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glioblastoma Radiotherapy Using IMRT or Proton Beams
- ClinicalTrials.gov ID
- NCT04752280
- Acronym / sponsor ID
- GRIPS / GRIPS
- Conditions
- Glioblastoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 19 Sep 2030 (estimated)
- Study completion
- 19 Jan 2033 (estimated)
- First posted
- 12 Feb 2021 (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.
Radiation therapy is an integral part of the multimodal primary therapy of glioblastomas. As the overall prognosis in this tumor entity remains unfavorable, current research is focused on additional drug therapies, which are often accompanied by increases in toxicity. By using proton beams instead of photon beams, it is possible to protect large parts of the brain which are not affected by the tumor more effectively. An initial retrospective matched-pair analysis showed that this theoretical physical benefit is also clinically associated with a reduction in toxicity during therapy and in the first few months thereafter. The aim of the GRIPS study is to prospectively test this clinical benefit in a randomized, open-label Phase III study. Patients are treated in the study using either modern photon radiation techniques (standard arm) or proton beams (experimental arm). The primary endpoint is the cumulative toxicity CTC grade 2 and higher in the first 4 months. Secondary endpoints include overall survival, progression-free survival, quality of life, and neurocognition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Proton irradiation | Experimental | Radiation: Proton irradiationIrradiation applied with protons |
| Arm B: Photon IMRT | Active comparator | Radiation: Photon irradiationPhoton irradiation applied as intensity-modulated radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- histologically confirmed gliomblastoma WHO IV (operated or after biopsy)
- Indication for radiotherapy / radiochemotherapy
- Informed consent
- KI ≥ 60% or ECOG 0/1
- Age ≥ 18 years
Key exclusion criteria (5 listed)
- Patient is not able to consent
- Previous radiotherapy in the brain or skull base
- Active medical implants for which there is no ion radiation authorization at the time of treatment (e.g., cardiac pacemaker, defibrillator, ...)
- Contraindication to MRI imaging
- Simultaneous participation in another clinical trial that could influence the outcome of this study or other 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 |
|---|---|---|
| Proton irradiationproton irradiation applied as follows: 30 x 2 Gy(RBE) 33 x 1,8 Gy (RBE), or 15 x 2,67 Gy (RBE) | Radiation | Arm A: Proton irradiation |
| Photon irradiationproton irradiation applied as follows: 30 x 2 Gy 33 x 1,8 Gy, or 15 x 2,67 Gy | Radiation | Arm B: Photon IMRT |
Primary outcome
Cumulative rate of toxicity
Time frame: from start of radiotherapy until progress (max. month 4)
Cumulative rate of toxicity ≥ grade 2 (until progress (max. month 4))
8 secondary outcomes
Progression free survival
Time frame: 1 year and 2 years
Overall survival
Time frame: 1 year and 2 years
Acute Toxicity
Time frame: start of therapy until 6 weeks after end of therapy (end of therapy up to month 4)
Late Toxicity
Time frame: 6 weeks after end of therapy (end of therapy up to month 4)
Quality of life according to EORTC QLQ-C30
Time frame: 1 year and 2 years
Quality of life according to EORTC QLQ-BN20
Time frame: 1 year and 2 years
Neurocognition
Time frame: 1 year and 2 years
Measuring number of Lymphocytes count
Time frame: end of therapy up to month 4
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 27 May 2026.
- Derived from this study: PubMed 34930368Konig L, Jakel C, von Knebel Doeberitz N, Kieser M, Eberle F, Munter M, Debus J, Herfarth K. Glioblastoma radiotherapy using Intensity modulated Radiotherapy (IMRT) or proton Radiotherapy-GRIPS Trial (Glioblastoma Radiotherapy via IMRT or Proton BeamS): a study protocol for a multicenter, prospective, open-label, randomized, two-arm, phase III study. Radiat Oncol. 2021 Dec 20;16(1):240. doi: 10.1186/s13014-021-01962-8.
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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.
Klaus Herfarth, Prof. Dr. contact
Laila König, Prof. Dr. principal investigator
University Hospital of Heidelberg, Radiation Oncology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton irradiation and Photon irradiation in people with Glioblastoma, run by University Hospital Heidelberg at 3 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 6 inclusion and 5 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 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Laila König, Prof. Dr. (+49 6221 56 36318 ext. 36318, studien.radonk@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative rate of toxicity (time frame: from start of radiotherapy until progress (max. month 4)). 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 NCT04752280, 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 27 May 2026.