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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Proton irradiation | Experimental | Irradiation applied with protons |
|
| Arm B: Photon IMRT | Active Comparator | Photon irradiation applied as intensity-modulated radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton irradiation | Radiation | proton irradiation applied as follows: 30 x 2 Gy(RBE) 33 x 1,8 Gy (RBE), or 15 x 2,67 Gy (RBE) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative rate of toxicity | Cumulative rate of toxicity ≥ grade 2 (until progress (max. month 4)) | from start of radiotherapy until progress (max. month 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Progression free survival | 1 year and 2 years |
| Overall survival | Overall survival | 1 year and 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laila König, Prof. Dr. | Contact | +49 6221 56 36318 | 36318 | studien.radonk@med.uni-heidelberg.de |
| Klaus Herfarth, Prof. Dr. | Contact | +49 6221 56 311584 | 34091 | studienkoordination.rad@med.uni-heidelberg.de |
| Name | Affiliation | Role |
|---|---|---|
| Laila König, Prof. Dr. | University Hospital of Heidelberg, Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Heidelberg | Recruiting | Heidelberg | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34930368 | Derived | 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. |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| Photon irradiation | Radiation | proton irradiation applied as follows: 30 x 2 Gy 33 x 1,8 Gy, or 15 x 2,67 Gy |
|
| Acute Toxicity | according to CTC AE V5.0 | 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 | 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 | 1 year and 2 years |
| Quality of life according to EORTC QLQ-BN20 | according to EORTC QLQ-BN20 | 1 year and 2 years |
| Neurocognition | according to Hopkins Verbal Learning Test-Revised | 1 year and 2 years |
| Measuring number of Lymphocytes count | end of therapy up to month 4 |
| Universitätsklinikum Gießen und Marburg | Not yet recruiting | Marburg | Germany |
|
| Klinikum Stuttgart | Not yet recruiting | Stuttgart | Germany |
|
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |