Glioblastoma Radiotherapy Using IMRT or Proton Beams (GRIPS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04752280 |
Recruitment Status :
Recruiting
First Posted : February 12, 2021
Last Update Posted : April 20, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioblastoma | Radiation: Proton irradiation Radiation: Photon irradiation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 326 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Glioblastoma Radiotherapy Using IMRT or Proton Beams |
Actual Study Start Date : | April 19, 2021 |
Estimated Primary Completion Date : | August 19, 2025 |
Estimated Study Completion Date : | October 19, 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm A: Proton irradiation
Irradiation applied with protons
|
Radiation: Proton irradiation
proton irradiation applied as follows: 30 x 2 Gy(RBE) 33 x 1,8 Gy (RBE), or 15 x 2,67 Gy (RBE) |
Active Comparator: Arm B: Photon IMRT
Photon irradiation applied as intensity-modulated radiotherapy
|
Radiation: Photon irradiation
proton irradiation applied as follows: 30 x 2 Gy 33 x 1,8 Gy, or 15 x 2,67 Gy |
- 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))
- Progression free survival [ Time Frame: 1 year and 2 years ]Progression free survival
- Overall survival [ Time Frame: 1 year and 2 years ]Overall survival
- Acute Toxicity [ Time Frame: start of therapy until 6 weeks after end of therapy (end of therapy up to month 4) ]according to CTC AE V5.0
- Late Toxicity [ Time Frame: 6 weeks after end of therapy (end of therapy up to month 4) ]according to CTC AE V5.0
- Quality of life according to EORTC QLQ-C30 [ Time Frame: 1 year and 2 years ]according to EORTC QLQ-C30
- Quality of life according to EORTC QLQ-BN20 [ Time Frame: 1 year and 2 years ]according to EORTC QLQ-BN20
- Neurocognition [ Time Frame: 1 year and 2 years ]according to Hopkins Verbal Learning Test-Revised
- Measuring number of Lymphocytes count [ Time Frame: end of therapy up to month 4 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04752280
Contact: Klaus Herfarth, Prof. Dr. | +49 6221 56 34093 | studienkoordination.RAD@med.uni-heidelberg.de |
Germany | |
Universitätsklinikum Heidelberg | Recruiting |
Heidelberg, Germany | |
Contact: Klaus Herfarth, Prof. Dr. | |
Universitätsklinikum Gießen und Marburg | Not yet recruiting |
Marburg, Germany | |
Contact: Rita Engenhart-Cabillic, Prof. Dr. | |
Klinikum Stuttgart | Not yet recruiting |
Stuttgart, Germany | |
Contact: Marc Münter, Prof. Dr. |
Responsible Party: | Juergen Debus, Prof. Dr. Dr. Jürgen Debus, University Hospital Heidelberg |
ClinicalTrials.gov Identifier: | NCT04752280 |
Other Study ID Numbers: |
GRIPS |
First Posted: | February 12, 2021 Key Record Dates |
Last Update Posted: | April 20, 2021 |
Last Verified: | April 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |