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.
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 currently participating in a prospective clinical trial studying a different treatment than the one studied in this current prospective study.
Patient currently breastfeeding.
Patient who is pregnant, thinks she might be pregnant or is trying to become pregnant. Patient of childbearing potential must use a contraceptive method for the whole duration of their participation in the study.
Patient suffering from a significant neurological disease (primary epilepsy, dementia, progressive degenerative neurological disorder, meningitis or encephalitis, hydrocephalus associated with increased intracranial pressure).
tdb
Other
Prospective
Not listed
Overall Survival (OS)
OS, defined as the time from the date of treatment initiation with Optune® to the date of death from any cause. Participants still alive at the time of the statistical analysis will be censored at the date they were last known to be alive
Health Related Quality of life - European Organization for Research and Treatment of Cancer C30 questionnaire
QoL will be assessed by the EORTC quality-of-life questionnaire. The EORTC QLQ-C30 is a 30-item questionnaire designed to assess the Health-Related Quality ofLife (HRQoL) of cancer patients that has been validated in brain cancer. It incorporates multi-item scales: functional scales (physical, role, cognitive, emotional, and social); symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. The items on the EORTC QLQ-C30 measures are scaled, scored, and transformed to a linear scale (0 -100) with a higher score representing a higher level of symptoms.
Health Related Quality of life - European Organization for Research and Treatment of Brain Cancer BN20 questionnaire
QoL will be assessed by the EORTC quality-of-life questionnaire. The EORTC QLQ-BN20, specifically developed and validated for patients with brain cancer, includes 20 items assessing visual disorder, motor dysfunction, various disease symptoms, treatment toxicity, and future uncertainty. The items on the EORTC QLQ-BN20 measures are scaled, scored, and transformed to a linear scale (0 -100) with a higher score representing a higher level of symptoms.
Usage of Optune Gio®
The 2 device specific questionnaires Optune Gio® initiation and follow-up were developed by Novocure to evaluate the factors influencing participants' decision to initiate treatment with Optune Gio® and the impact of Optune Gio® treatment on participants' daily life. The Optune Gio® initiation questionnaire will be administered before the initiation of Optune Gio® treatment. This questionnaire consists of 9 questions: 3 questions relate to the information about Optune Gio® received by the participants (when, how long and with whom) 6 questions relate to the factors influencing participants' decision to initiation Optune Gio® treatment: 5 questions answered using a 5-point Likert scale from not at all to very much plus one free text question. The Optune Gio® follow-up questionnaire will be administered 2 and 4 months after Optune Gio® treatment initiation. It consists of 6 questions, each of them answered using a 5-level Likert scale from not at all to much more than expected.
Progression Free Survival
PFS under TTFields treatment, defined as the time from the date of treatment initiation with Optune® to the date of first documented radiological progression reported by investigators or death from any cause.
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