An observational study in Glioblastoma, sponsored by NovoCure Ltd.. Recruiting at 24 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by NovoCure Ltd. · Observational
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.
GBM is one of the most common malignant primary brain tumor in adults with an overall incidence in Europe and in France of approximately 3/100,000. In France, 2,233 patients were estimated to be diagnosed with histologically-confirmed GBM in France in 2020. GBM are particularly aggressive and treatment resistant, with a 5-year overall survival (OS) of only 7.0 % in France. Since 2005, standard treatment for newly diagnosed GBM consists of maximal feasible surgical resection or biopsy followed by standard brain radiation therapy with concomitant temozolomide (TMZ) and a further 6 cycles of TMZ alone (Stupp protocol). This treatment demonstrated a significant increase in median OS compared to surgery and radiotherapy alone (14.6 vs 12.1 months).
Since 2005, despite several of phase III clinical trials conducted, TTFields treatment was the first to report a significant improvement in GBM patients' survival compared to the previous standard of care. This pivotal phase III clinical trial randomized 695 patients with newly diagnosed GBM receiving either TTFields plus maintenance TMZ or TMZ alone, after completion of standard radiochemotherapy. Adding TTFields to maintenance TMZ significantly improved median progression-free survival (PFS) and median OS compared to TMZ alone. Impact of TTFields on survival appeared comparable to that achieved by the addition of TMZ to radiotherapy.
These results led to FDA approval of Optune Gio® and to CE mark in the European Union in association with maintenance TMZ in patients with newly diagnosed GBM, after surgery and radiotherapy with adjuvant TMZ. Optune Gio® obtained national reimbursement in several European countries in this indication, as Germany, Switzerland, Sweden and France. The National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) issued on 20 July 2021 a positive opinion to Optune Gio® for inclusion into the reimbursement list in the following indication: "in association with maintenance TMZ, after surgery and radiochemotherapy in patients with newly diagnosed GBM, as part of a shared decision between the patient and the medical team".
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 initiating treatment 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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's planned enrollment of 430 is above the median of 60 across 188 observational studies indexed under Glioblastoma.
Browse Glioblastoma studies →NovoCure Ltd. is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
Time frame: through study completion, an average of 18 months (mean FU time)
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.
Time frame: at start of TTFields treatment, at month 2, month 4, month 6, month 12 and month 18 after start of TTFields treatment
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.
Time frame: at start of TTFields treatment, at month 2, month 4, month 6, month 12 and month 18 after start of TTFields treatment
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.
Time frame: at start of TTFields treatment, month 2 and month 4 after start of TTFields treatment
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.
Time frame: through study completion, an average of 18 months (mean follow-up time)
Optune Gio® safety profile and deficiencies
All non-serious AEs will be assessed according to incidence and causality. All SAEs will be assessed according to incidence, grade, causality, outcome, and action taken. Potential DDs of Optune® device that might have led to a SAE if no action had been taken will also be collected and presented descriptively.
Time frame: through study completion, an average of 18 months (mean follow-up time)
Plan to share: No
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NovoCure Ltd.