Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04752280
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2021-02-09
Brief Title:
Glioblastoma Radiotherapy Using IMRT or Proton Beams
Sponsor:
University Hospital Heidelberg
Organization:
University Hospital Heidelberg
Study Overview
Official Title:
Glioblastoma Radiotherapy Using IMRT or Proton Beams
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GRIPS
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None