Clinical trial NCT06924099: TTFields General Routine Clinical Care in ndGBM Patients: a French Prospective Non-Interventional Study (TIGER France)
Official title: Tumor Treating Fields General Routine Clinical Care in Newly Diagnosed Glioblastoma Patients: a French Prospective Non-Interventional Study - TIGER France
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioblastoma
Keywords: newly diagnosed Glioblastoma (GBM)
Tumor Treating Fields - TTFields
Lead sponsor: NovoCure Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-11
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: tdb

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* Patient with a known sensitivity to conductive hydrogels, such as gel used with electrocardiogram (ECG) or transcutaneous electrical nerve stimulation (TENS) electrodes.
* Patient with an active implanted medical device, a cranial defect (such as a missing bone that has not been replaced) or bullet fragments. Active electronic devices include, for example, deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers and defibrillators.
* Participant being deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection (e.g. guardianship or curatorship).

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: through study completion, an average of 18 months (mean FU time)
Secondary outcomes:
measure: Health Related Quality of life - European Organization for Research and Treatment of Cancer C30 questionnaire
timeFrame: at start of TTFields treatment, at month 2, month 4, month 6, month 12 and month 18 after start of TTFields treatment
measure: Health Related Quality of life - European Organization for Research and Treatment of Brain Cancer BN20 questionnaire
timeFrame: at start of TTFields treatment, at month 2, month 4, month 6, month 12 and month 18 after start of TTFields treatment
measure: Usage of Optune Gio®
timeFrame: at start of TTFields treatment, month 2 and month 4 after start of TTFields treatment
measure: Progression Free Survival
timeFrame: through study completion, an average of 18 months (mean follow-up time)
measure: Optune Gio® safety profile and deficiencies
timeFrame: through study completion, an average of 18 months (mean follow-up time)
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens Picardie
city: Avignon
country: France
facility: Institut Sainte-Catherine
city: Bordeaux
country: France
facility: Chu Saint Andre
city: Brest
country: France
facility: Chu Brest Hopital Morvan
city: Bron
country: France
facility: Hopital Neurologie Pierre Wetrheimer
city: Caen
country: France
facility: Crlcc Francois Baclesse
city: Clermont-Ferrand
country: France
facility: Centre Lutte Contre Le Cancer Jean Perrin
city: Dijon
country: France
facility: Crlcc Georges Francois Leclerc
city: La Tronche
country: France
facility: Chu de Grenoble Alpes
city: Lille
country: France
facility: Hopital Roger Salengro
city: Marseille
country: France
facility: Centre Hospitalier La Timone
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier - Val d'Aurelle
city: Nice
country: France
facility: CHU de Nice
city: Nîmes
country: France
facility: CHU de Nîmes - HOPITAL CAREMEAU
city: Orléans
country: France
facility: Ch Regional Orleans
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Gh Pitie Salpetriere Aphp
city: Rennes
country: France
facility: CRLCC - Centre Eugène Marquis
city: Rouen
country: France
facility: Crlcc Henri Becquerel
city: Saint-Priest-en-Jarez
country: France
facility: Chu de Saint Etienne
city: Suresnes
country: France
facility: Hopital Foch
city: Toulon
country: France
facility: Hia Sainte Anne
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References: