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

Last updated: April 4, 2025
Sponsor: NovoCure Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gliomas

Astrocytoma

Treatment

N/A

Clinical Study ID

NCT06924099
TIGER France
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  • Participant currently participating in a prospective clinical trial studying adifferent 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 becomepregnant. Patient of childbearing potential must use a contraceptive method for thewhole duration of their participation in the study.

  • Patient suffering from a significant neurological disease (primary epilepsy,dementia, progressive degenerative neurological disorder, meningitis orencephalitis, hydrocephalus associated with increased intracranial pressure).

  • Patient with a known sensitivity to conductive hydrogels, such as gel used withelectrocardiogram (ECG) or transcutaneous electrical nerve stimulation (TENS)electrodes.

  • Patient with an active implanted medical device, a cranial defect (such as a missingbone that has not been replaced) or bullet fragments. Active electronic devicesinclude, for example, deep brain stimulators, spinal cord stimulators, vagus nervestimulators, pacemakers and defibrillators.

  • Participant being deprived of liberty by a judicial or administrative decision, orwho is under a measure of legal protection (e.g. guardianship or curatorship).

Study Design

Total Participants: 430
Study Start date:
January 11, 2024
Estimated Completion Date:
January 31, 2029

Study 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.

Connect with a study center

  • Chu Amiens Picardie

    Amiens, 80000
    France

    Active - Recruiting

  • Institut Sainte-Catherine

    Avignon, 84000
    France

    Active - Recruiting

  • Chu Saint Andre

    Bordeaux, 33000
    France

    Active - Recruiting

  • Chu Brest Hopital Morvan

    Brest, 29609
    France

    Active - Recruiting

  • Hopital Neurologie Pierre Wetrheimer

    Bron, 69500
    France

    Active - Recruiting

  • Crlcc Francois Baclesse

    Caen, 14000
    France

    Active - Recruiting

  • Centre Lutte Contre Le Cancer Jean Perrin

    Clermont-Ferrand, 63011
    France

    Active - Recruiting

  • Crlcc Georges Francois Leclerc

    Dijon, 21000
    France

    Active - Recruiting

  • Chu de Grenoble Alpes

    La Tronche, 38700
    France

    Active - Recruiting

  • Hopital Roger Salengro

    Lille, 59000
    France

    Active - Recruiting

  • Centre Hospitalier La Timone

    Marseille, 13000
    France

    Active - Recruiting

  • Institut du Cancer de Montpellier - Val d'Aurelle

    Montpellier, 34298
    France

    Active - Recruiting

  • CHU de Nice

    Nice, 06000
    France

    Active - Recruiting

  • CHU de Nîmes - HOPITAL CAREMEAU

    Nîmes, 30000
    France

    Active - Recruiting

  • Ch Regional Orleans

    Orléans, 45067
    France

    Active - Recruiting

  • Gh Pitie Salpetriere Aphp

    Paris,
    France

    Active - Recruiting

  • Hopital Saint Louis

    Paris, 75010
    France

    Active - Recruiting

  • CRLCC - Centre Eugène Marquis

    Rennes, 35000
    France

    Active - Recruiting

  • Crlcc Henri Becquerel

    Rouen, 76000
    France

    Active - Recruiting

  • Chu de Saint Etienne

    Saint-Priest-en-Jarez, 42271
    France

    Active - Recruiting

  • Hopital Foch

    Suresnes, 92151
    France

    Active - Recruiting

  • Hia Sainte Anne

    Toulon, 83000
    France

    Active - Recruiting

  • Institut Claudius Regaud

    Toulouse, 31059
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Active - Recruiting

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