TTFields General Routine Clinical Care in ndGBM Patients: a French Prospective Non-Interventional Study (TIGER France)
TIGER France
Tumor Treating Fields General Routine Clinical Care in Newly Diagnosed Glioblastoma Patients: a French Prospective Non-Interventional Study - TIGER France
1 other identifier
observational
430
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2024
Longer than P75 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 11, 2024
CompletedFirst Submitted
Initial submission to the registry
September 18, 2024
CompletedFirst Posted
Study publicly available on registry
April 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2029
April 11, 2025
May 1, 2024
5.1 years
September 18, 2024
April 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
through study completion, an average of 18 months (mean FU time)
Secondary Outcomes (5)
Health Related Quality of life - European Organization for Research and Treatment of Cancer C30 questionnaire
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
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®
at start of TTFields treatment, month 2 and month 4 after start of TTFields treatment
Progression Free Survival
through study completion, an average of 18 months (mean follow-up time)
Optune Gio® safety profile and deficiencies
through study completion, an average of 18 months (mean follow-up time)
Eligibility Criteria
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You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NovoCure Ltd.lead
Study Sites (24)
Chu Amiens Picardie
Amiens, 80000, France
Institut Sainte-Catherine
Avignon, 84000, France
Chu Saint Andre
Bordeaux, 33000, France
Chu Brest Hopital Morvan
Brest, 29609, France
Hopital Neurologie Pierre Wetrheimer
Bron, 69500, France
Crlcc Francois Baclesse
Caen, 14000, France
Centre Lutte Contre Le Cancer Jean Perrin
Clermont-Ferrand, 63011, France
Crlcc Georges Francois Leclerc
Dijon, 21000, France
Chu de Grenoble Alpes
La Tronche, 38700, France
Hopital Roger Salengro
Lille, 59000, France
Centre Hospitalier La Timone
Marseille, 13000, France
Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, 34298, France
CHU de Nice
Nice, 06000, France
CHU de Nîmes - HOPITAL CAREMEAU
Nîmes, 30000, France
Ch Regional Orleans
Orléans, 45067, France
Hopital Saint Louis
Paris, 75010, France
Gh Pitie Salpetriere Aphp
Paris, France
CRLCC - Centre Eugène Marquis
Rennes, 35000, France
Crlcc Henri Becquerel
Rouen, 76000, France
Chu de Saint Etienne
Saint-Priest-en-Jarez, 42271, France
Hopital Foch
Suresnes, 92151, France
Hia Sainte Anne
Toulon, 83000, France
Institut Claudius Regaud
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2024
First Posted
April 11, 2025
Study Start
January 11, 2024
Primary Completion (Estimated)
January 31, 2029
Study Completion (Estimated)
January 31, 2029
Last Updated
April 11, 2025
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share