Tumor Treating Fields General Routine Clinical Care in Newly Diagnosed Glioblastoma Patients: a French Prospective Non-Interventional Study - TIGER France
Status: Recruiting
Location: See all (24) locations...
Study Type: Observational
SUMMARY
This prospective multicenter non-interventional study (NIS) aims at confirming the survival benefit of Optune Gio® - in terms of OS and PFS - and describing device usage (compliance will be measured through patient's usage report, recorded by each device) and impact on QoL, in a real-life setting in France, in a large cohort of participants with newly diagnosed GBM who completed radiotherapy and concomitant TMZ after surgery and initiatingtreatment with Optune Gio® device together with maintenance TMZ. A special emphasis will be given to the evaluation of QoL and the impact of Optune Gio® on daily life, considering the limited life expectancy of these patients, the symptom burden and significant disease-related disability.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Participant aged ≥ 18 years old.
• Participant with newly diagnosed GBM.
• Participant who completed radiochemotherapy after surgery or biopsy.
• Participant within first 2 cycles of maintenance TMZ.
• Participant for whom the physician has decided to initiate treatment with Optune® according to Instruction For Use or medical guidelines.