Status:
UNKNOWN
TTFields In GErmany in Routine Clinical Care
Lead Sponsor:
NovoCure Ltd.
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this post-authorisation medical device study is to obtain real life data on the use of tumor-treating fields (TTFields) in patients with newly diagnosed GBM in routine clinical care in ...
Detailed Description
Glioblastoma (GBM) is the most common malignant primary tumor of the brain. The current standard of care for patients with newly diagnosed GBM consists of maximal surgical resection, approx. 60 Gy of ...
Eligibility Criteria
Inclusion
- Newly diagnosed histologically confirmed GBM (WHO-Grade IV)
- Patient within first 3 cycles of first-line tumor-specific maintenance chemotherapy
- ≥ 18 years of age
- Clinical indication for TTFields treatment
- Given informed consent for use and processing of data
Exclusion
- Present or planned pregnancy
- Significant additional neurological disease (e.g. significantly increased intracerebral pressure (ICP) with a significant midline shift of the brain)
- Active implanted medical device (e.g. deep brain stimulator)
- Documented allergy to conductive hydrogel
- Skull defect (e.g. missing bone with no replacement, bullet fragments in the skull)
Key Trial Info
Start Date :
August 31 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
710 Patients enrolled
Trial Details
Trial ID
NCT03258021
Start Date
August 31 2017
End Date
July 1 2021
Last Update
January 28 2021
Active Locations (1)
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1
Clinical center Aschaffenburg-Alzenau
Aschaffenburg, Bavaria, Germany, 63739