TTFields General Routine Clinical Care in ndGBM Patients: a French Prospective Non-Interventional Study (TIGER France)

NCT ID: NCT06924099

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 430 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-11
• Study Completion Date: 2029-01-31

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.

Conditions

Glioblastoma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NovoCure Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Amiens Picardie

Amiens, , France

Site Status: RECRUITING

Institut Sainte-Catherine

Avignon, , France

Site Status: RECRUITING

Chu Saint Andre

Bordeaux, , France

Site Status: RECRUITING

Chu Brest Hopital Morvan

Brest, , France

Site Status: RECRUITING

Hopital Neurologie Pierre Wetrheimer

Bron, , France

Site Status: RECRUITING

Crlcc Francois Baclesse

Caen, , France

Site Status: RECRUITING

Centre Lutte Contre Le Cancer Jean Perrin

Clermont-Ferrand, , France

Site Status: RECRUITING

Crlcc Georges Francois Leclerc

Dijon, , France

Site Status: RECRUITING

Chu de Grenoble Alpes

La Tronche, , France

Site Status: RECRUITING

Hopital Roger Salengro

Lille, , France

Site Status: RECRUITING

Centre Hospitalier La Timone

Marseille, , France

Site Status: RECRUITING

Institut du Cancer de Montpellier - Val d'Aurelle

Montpellier, , France

Site Status: RECRUITING

CHU de Nice

Nice, , France

Site Status: RECRUITING

CHU de Nîmes - HOPITAL CAREMEAU

Nîmes, , France

Site Status: RECRUITING

Ch Regional Orleans

Orléans, , France

Site Status: RECRUITING

Hopital Saint Louis

Paris, , France

Site Status: RECRUITING

Gh Pitie Salpetriere Aphp

Paris, , France

Site Status: RECRUITING

CRLCC - Centre Eugène Marquis

Rennes, , France

Site Status: RECRUITING

Crlcc Henri Becquerel

Rouen, , France

Site Status: RECRUITING

Chu de Saint Etienne

Saint-Priest-en-Jarez, , France

Site Status: RECRUITING

Hopital Foch

Suresnes, , France

Site Status: RECRUITING

Hia Sainte Anne

Toulon, , France

Site Status: RECRUITING

Institut Claudius Regaud

Toulouse, , France

Site Status: RECRUITING

Institut Gustave Roussy

Villejuif, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

CHU AMIENS PICARDIE

Role: primary

+33

inst INSTITUT SAINTE-CATHERINE

Role: primary

+33

CHU SAINT ANDRE

Role: primary

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CHU BREST HOPITAL MORVAN

Role: primary

+33

Hop HOPITAL NEUROLOGIE PIERRE WETRHEIMER

Role: primary

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CRLCC FRANCOIS BACLESSE

Role: primary

+33

CRLCC CENTRE LUTTE CONTRE LE CANCER JEAN PERRIN

Role: primary

+33

CRLCC GEORGES FRANCOIS LECLERC

Role: primary

+33

chu CHU DE GRENOBLE ALPES

Role: primary

+33

HOPITAL ROGER SALENGRO

Role: primary

+33

CH LA TIMONE

Role: primary

+33

inst Institut du Cancer de Montpellier - Val d'Aurelle

Role: primary

+33

CHU CHU de Nice

Role: primary

+33

CHU CHU de Nîmes - HOPITAL CAREMEAU

Role: primary

+33

CHR CH REGIONAL ORLEANS

Role: primary

+33

HOPITAL SAINT LOUIS

Role: primary

+33

GH PITIE SALPETRIERE

Role: primary

+33

CRLCC Centre Eugène Marquis

Role: primary

+33

CRLCC HENRI BECQUEREL

Role: primary

+33

CHU CHU DE SAINT ETIENNE

Role: primary

+33

Hop HOPITAL FOCH

Role: primary

+33

hia HIA SAINTE ANNE

Role: primary

+33

inst INSTITUT CLAUDIUS REGAUD

Role: primary

+33

inst INSTITUT GUSTAVE ROUSSY

Role: primary

+33

Other Identifiers

TIGER France

Identifier Type: -

Identifier Source: org_study_id