Glioblastoma Radiotherapy Using IMRT or Proton Beams

Overview

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.

Interventions

• 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)
• Radiation Photon irradiation
  proton irradiation applied as follows: 30 x 2 Gy 33 x 1,8 Gy, or 15 x 2,67 Gy

Primary outcome measures

• Cumulative rate of toxicity [Time frame: from start of radiotherapy until progress (max. month 4)]

Secondary outcome measures (8)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 3 centers

• Universitätsklinikum Heidelberg — Heidelberg
• Universitätsklinikum Gießen und Marburg — Marburg
• Klinikum Stuttgart — Stuttgart

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: 10.11 PMID 34930368

Identifiers

NCT: NCT04752280 · GRIPS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗