Glioblastoma Radiotherapy Using IMRT or Proton Beams

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Universitätsklinikum Heidelberg
RECRUITING
Heidelberg
Universitätsklinikum Gießen und Marburg
NOT_YET_RECRUITING
Marburg
Klinikum Stuttgart
NOT_YET_RECRUITING
Stuttgart
Contact Information
Primary
Klaus Herfarth, Prof. Dr.
studienkoordination.RAD@med.uni-heidelberg.de
+49 6221 56 34093
Time Frame
Start Date: 2021-04-19
Estimated Completion Date: 2027-10-19
Participants
Target number of participants: 326
Treatments
Experimental: Arm A: Proton irradiation
Irradiation applied with protons
Active_comparator: Arm B: Photon IMRT
Photon irradiation applied as intensity-modulated radiotherapy
Sponsors
Leads: University Hospital Heidelberg

This content was sourced from clinicaltrials.gov