GRIPS
Glioblastoma Radiotherapy Using IMRT or Proton Beams
Rekrutierend
NCT-Nummer:
NCT04752280
Studienbeginn:
April 2021
Letztes Update:
05.01.2024
Wirkstoff:
-
Indikation (Clinical Trials):
Glioblastoma
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
University Hospital Heidelberg
Collaborator:
-
Kontakt
Klaus Herfarth, Prof. Dr.
Kontakt:
Phone: +49 6221 56 34093
E-Mail: studienkoordination.RAD@med.uni-heidelberg.de» Kontaktdaten anzeigen
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.
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 outcome:
1. 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))
Secondary outcome:
1. Progression free survival (Time Frame - 1 year and 2 years):
Progression free survival
2. Overall survival (Time Frame - 1 year and 2 years):
Overall survival
3. 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
4. Late Toxicity (Time Frame - 6 weeks after end of therapy (end of therapy up to month 4)):
according to CTC AE V5.0
5. Quality of life according to EORTC QLQ-C30 (Time Frame - 1 year and 2 years):
according to EORTC QLQ-C30
6. Quality of life according to EORTC QLQ-BN20 (Time Frame - 1 year and 2 years):
according to EORTC QLQ-BN20
7. Neurocognition (Time Frame - 1 year and 2 years):
according to Hopkins Verbal Learning Test-Revised
8. Measuring number of Lymphocytes count (Time Frame - end of therapy up to month 4)
- Experimental: Arm A: Proton irradiation
Irradiation applied with protons - Active Comparator: Arm B: Photon IMRT
Photon irradiation applied as intensity-modulated radiotherapy
- 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) - Photon irradiation:
proton irradiation applied as follows: 30 x 2 Gy 33 x 1,8 Gy, or 15 x 2,67 Gy
Quelle: ClinicalTrials.gov
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