Glioblastoma
Conditions
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.
Interventions
RADIATIONProton irradiation
proton irradiation applied as follows: 30 x 2 Gy(RBE) 33 x 1,8 Gy (RBE), or 15 x 2,67 Gy (RBE)
RADIATIONPhoton irradiation
proton irradiation applied as follows: 30 x 2 Gy 33 x 1,8 Gy, or 15 x 2,67 Gy
Sponsors
University Hospital Heidelberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative rate of toxicity | from start of radiotherapy until progress (max. month 4) | Cumulative rate of toxicity ≥ grade 2 (until progress (max. month 4)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 1 year and 2 years | Progression free survival |
| Overall survival | 1 year and 2 years | Overall survival |
| Acute Toxicity | 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 | 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 | 1 year and 2 years | according to EORTC QLQ-C30 |
| Quality of life according to EORTC QLQ-BN20 | 1 year and 2 years | according to EORTC QLQ-BN20 |
| Neurocognition | 1 year and 2 years | according to Hopkins Verbal Learning Test-Revised |
| Measuring number of Lymphocytes count | end of therapy up to month 4 | — |
Countries
Germany
Contacts
CONTACTLaila König, Prof. Dr.
CONTACTKlaus Herfarth, Prof. Dr.
PRINCIPAL_INVESTIGATORLaila König, Prof. Dr.
University Hospital of Heidelberg, Radiation Oncology
Outcome results
None listed