Clinical trial NCT04752280: Glioblastoma Radiotherapy Using IMRT or Proton Beams
Official title: Glioblastoma Radiotherapy Using IMRT or Proton Beams
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioblastoma
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


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

Primary outcomes:
measure: Cumulative rate of toxicity
timeFrame: from start of radiotherapy until progress (max. month 4)
Secondary outcomes:
measure: Progression free survival
timeFrame: 1 year and 2 years
measure: Overall survival
timeFrame: 1 year and 2 years
measure: Acute Toxicity
timeFrame: start of therapy until 6 weeks after end of therapy (end of therapy up to month 4)
measure: Late Toxicity
timeFrame: 6 weeks after end of therapy (end of therapy up to month 4)
measure: Quality of life according to EORTC QLQ-C30
timeFrame: 1 year and 2 years
measure: Quality of life according to EORTC QLQ-BN20
timeFrame: 1 year and 2 years
measure: Neurocognition
timeFrame: 1 year and 2 years
measure: Measuring number of Lymphocytes count
timeFrame: end of therapy up to month 4
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen und Marburg
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart
Study officials:
References:
citation: 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.