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Observes a device-based treatment in people with newly diagnosed glioblastoma in France

Studies Optune Gio use with temozolomide in adults with newly diagnosed glioblastoma.

Key facts

Who runs it
NovoCure Ltd.
Where
Amiens, Avignon, Bordeaux, Brest, Bron, Caen, Clermont-Ferrand, Dijon, La Tronche, Lille, Marseille, Montpellier, Nice, Nîmes, Orléans, Paris, Rennes, Rouen, Saint-Priest-en-Jarez, Suresnes, Toulon, Toulouse, and Villejuif, FranceSee the 24 sites
Trial code
Registry title
TTFields General Routine Clinical Care in ndGBM Patients: a French Prospective Non-Interventional Study (TIGER France)
Status
Recruiting
People taking part
430 people, planned
Started
11 Jan 2024
Expected to end
31 Jan 2029
Type of study
Observational
Record updated
11 April 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with newly diagnosed glioblastoma who finished radiotherapy with chemotherapy after surgery and whose doctor has decided to start Optune treatment.

Age
18 years or older
Sex
All sexes
Disease stage
Newly diagnosed glioblastoma (GBM)
Earlier treatment
Must have finished radiochemotherapy after surgery or biopsy. Must be within the first 2 cycles of maintenance TMZ. The physician has decided to start Optune treatment.

Main reasons for not taking part

  • Taking part in another prospective clinical trial of a different treatment
  • Pregnant, trying to become pregnant, or breastfeeding
  • Significant neurological disease such as primary epilepsy, dementia, meningitis or encephalitis
  • Known sensitivity to conductive hydrogels
  • Active implanted medical device, cranial defect or bullet fragments

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in France

  • Chu Amiens PicardieAmiens, FranceContact: CHU AMIENS PICARDIETaking people
  • Institut Sainte-CatherineAvignon, FranceContact: inst INSTITUT SAINTE-CATHERINETaking people
  • Chu Saint AndreBordeaux, FranceContact: CHU SAINT ANDRETaking people
  • Chu Brest Hopital MorvanBrest, FranceContact: CHU BREST HOPITAL MORVANTaking people
  • Hopital Neurologie Pierre WetrheimerBron, FranceContact: Hop HOPITAL NEUROLOGIE PIERRE WETRHEIMERTaking people
  • Crlcc Francois BaclesseCaen, FranceContact: CRLCC FRANCOIS BACLESSETaking people
  • Centre Lutte Contre Le Cancer Jean PerrinClermont-Ferrand, FranceContact: CRLCC CENTRE LUTTE CONTRE LE CANCER JEAN PERRINTaking people
  • Crlcc Georges Francois LeclercDijon, FranceContact: CRLCC GEORGES FRANCOIS LECLERCTaking people
  • Chu de Grenoble AlpesLa Tronche, FranceContact: chu CHU DE GRENOBLE ALPESTaking people
  • Hopital Roger SalengroLille, FranceContact: HOPITAL ROGER SALENGROTaking people
  • Centre Hospitalier La TimoneMarseille, FranceContact: CH LA TIMONETaking people
  • Institut du Cancer de Montpellier - Val d'AurelleMontpellier, FranceContact: inst Institut du Cancer de Montpellier - Val d'AurelleTaking people
  • CHU de NiceNice, FranceContact: CHU CHU de NiceTaking people
  • CHU de Nîmes - HOPITAL CAREMEAUNîmes, FranceContact: CHU CHU de Nîmes - HOPITAL CAREMEAUTaking people
  • Ch Regional OrleansOrléans, FranceContact: CHR CH REGIONAL ORLEANSTaking people
  • Gh Pitie Salpetriere AphpParis, FranceContact: GH PITIE SALPETRIERETaking people
  • Hopital Saint LouisParis, FranceContact: HOPITAL SAINT LOUISTaking people
  • CRLCC - Centre Eugène MarquisRennes, FranceContact: CRLCC Centre Eugène MarquisTaking people
  • Crlcc Henri BecquerelRouen, FranceContact: CRLCC HENRI BECQUERELTaking people
  • Chu de Saint EtienneSaint-Priest-en-Jarez, FranceContact: CHU CHU DE SAINT ETIENNETaking people
  • Hopital FochSuresnes, FranceContact: Hop HOPITAL FOCHTaking people
  • Hia Sainte AnneToulon, FranceContact: hia HIA SAINTE ANNETaking people
  • Institut Claudius RegaudToulouse, FranceContact: inst INSTITUT CLAUDIUS REGAUDTaking people
  • Institut Gustave RoussyVillejuif, FranceContact: inst INSTITUT GUSTAVE ROUSSYTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Tumor Treating Fields General Routine Clinical Care in Newly Diagnosed Glioblastoma Patients: a French Prospective Non-Interventional Study - TIGER France
Plain-language title
Observes a device-based treatment in people with newly diagnosed glioblastoma in FranceGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
11 April 2025