GlioblastomaTIGER FranceNCT06924099
TTFields General Routine Clinical Care in ndGBM Patients: a French Prospective Non-Interventional Study (TIGER France)
An observational study of Glioblastoma, run by NovoCure Ltd. at 24 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- How many people
- 430 participants
- Where
- 24 sitesFrance
- Study dates
- 11 Jan 2024to 31 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: tdb
Who may be able to join
- 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 join
- 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).
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
France24 sites, 24 recruiting
- Recruiting
Chu Amiens Picardie
Amiens, 80000
CHU AMIENS PICARDIE, +33
- Recruiting
Institut Sainte-Catherine
Avignon, 84000
inst INSTITUT SAINTE-CATHERINE, +33
- Recruiting
Chu Saint Andre
Bordeaux, 33000
CHU SAINT ANDRE, +33
- Recruiting
Chu Brest Hopital Morvan
Brest, 29609
CHU BREST HOPITAL MORVAN, +33
- Recruiting
Hopital Neurologie Pierre Wetrheimer
Bron, 69500
Hop HOPITAL NEUROLOGIE PIERRE WETRHEIMER, +33
- Recruiting
Crlcc Francois Baclesse
Caen, 14000
CRLCC FRANCOIS BACLESSE, +33
- Recruiting
Centre Lutte Contre Le Cancer Jean Perrin
Clermont-Ferrand, 63011
CRLCC CENTRE LUTTE CONTRE LE CANCER JEAN PERRIN, +33
- Recruiting
Crlcc Georges Francois Leclerc
Dijon, 21000
CRLCC GEORGES FRANCOIS LECLERC, +33
- Recruiting
Chu de Grenoble Alpes
La Tronche, 38700
chu CHU DE GRENOBLE ALPES, +33
- Recruiting
Hopital Roger Salengro
Lille, 59000
HOPITAL ROGER SALENGRO, +33
- Recruiting
Centre Hospitalier La Timone
Marseille, 13000
CH LA TIMONE, +33
- Recruiting
Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, 34298
inst Institut du Cancer de Montpellier - Val d'Aurelle, +33
- Recruiting
CHU de Nice
Nice, 06000
CHU CHU de Nice, +33
- Recruiting
CHU de Nîmes - HOPITAL CAREMEAU
Nîmes, 30000
CHU CHU de Nîmes - HOPITAL CAREMEAU, +33
- Recruiting
Ch Regional Orleans
Orléans, 45067
CHR CH REGIONAL ORLEANS, +33
- Recruiting
Hopital Saint Louis
Paris, 75010
HOPITAL SAINT LOUIS, +33
- Recruiting
Gh Pitie Salpetriere Aphp
Paris
GH PITIE SALPETRIERE, +33
- Recruiting
CRLCC - Centre Eugène Marquis
Rennes, 35000
CRLCC Centre Eugène Marquis, +33
- Recruiting
Crlcc Henri Becquerel
Rouen, 76000
CRLCC HENRI BECQUEREL, +33
- Recruiting
Chu de Saint Etienne
Saint-Priest-en-Jarez, 42271
CHU CHU DE SAINT ETIENNE, +33
- Recruiting
Hopital Foch
Suresnes, 92151
Hop HOPITAL FOCH, +33
- Recruiting
Hia Sainte Anne
Toulon, 83000
hia HIA SAINTE ANNE, +33
- Recruiting
Institut Claudius Regaud
Toulouse, 31059
inst INSTITUT CLAUDIUS REGAUD, +33
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
inst INSTITUT GUSTAVE ROUSSY, +33
About this study
Official title: Tumor Treating Fields General Routine Clinical Care in Newly Diagnosed Glioblastoma Patients: a French Prospective Non-Interventional Study - TIGER France
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.
Read the 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
- Keywords
- newly diagnosed Glioblastoma (GBM), Tumor Treating Fields - TTFields
- Medical subject headings
- Glioblastoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
QoL will be assessed by the EORTC quality-of-life questionnaire. The EORTC QLQ-C30 is a 30-item questionnaire designed to assess the Health-Related Quality ofLife (HRQoL) of cancer patients that has been validated in brain cancer. It incorporates multi-item scales: functional scales (physical, role, cognitive, emotional, and social); symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. The items on the EORTC QLQ-C30 measures are scaled, scored, and transformed to a linear scale (0 -100) with a higher score representing a higher level of symptoms.
Measured: 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
QoL will be assessed by the EORTC quality-of-life questionnaire. The EORTC QLQ-BN20, specifically developed and validated for patients with brain cancer, includes 20 items assessing visual disorder, motor dysfunction, various disease symptoms, treatment toxicity, and future uncertainty. The items on the EORTC QLQ-BN20 measures are scaled, scored, and transformed to a linear scale (0 -100) with a higher score representing a higher level of symptoms.
Measured: 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®
The 2 device specific questionnaires Optune Gio® initiation and follow-up were developed by Novocure to evaluate the factors influencing participants' decision to initiate treatment with Optune Gio® and the impact of Optune Gio® treatment on participants' daily life. The Optune Gio® initiation questionnaire will be administered before the initiation of Optune Gio® treatment. This questionnaire consists of 9 questions:
3 questions relate to the information about Optune Gio® received by the participants (when, how long and with whom) 6 questions relate to the factors influencing participants' decision to initiation Optune Gio® treatment: 5 questions answered using a 5-point Likert scale from not at all to very much plus one free text question.
The Optune Gio® follow-up questionnaire will be administered 2 and 4 months after Optune Gio® treatment initiation. It consists of 6 questions, each of them answered using a 5-level Likert scale from not at all to much more than expected.
Measured: at start of TTFields treatment, month 2 and month 4 after start of TTFields treatment
Progression Free Survival
PFS under TTFields treatment, defined as the time from the date of treatment initiation with Optune® to the date of first documented radiological progression reported by investigators or death from any cause.
Measured: through study completion, an average of 18 months (mean follow-up time)
Optune Gio® safety profile and deficiencies
All non-serious AEs will be assessed according to incidence and causality. All SAEs will be assessed according to incidence, grade, causality, outcome, and action taken. Potential DDs of Optune® device that might have led to a SAE if no action had been taken will also be collected and presented descriptively.
Measured: through study completion, an average of 18 months (mean follow-up time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start11 Jan 2024
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovoCure Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924099
- Sponsor's protocol ID
- TIGER France
- Acronym
- TIGER France
- Status last verified
- May 2024
- First submitted
- 18 Sep 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Treating Fields General Routine Clinical Care in Newly Diagnosed Glioblastoma Patients: a French Prospective Non-Interventional Study - TIGER France
- ClinicalTrials.gov ID
- NCT06924099
- Acronym / sponsor ID
- TIGER France / TIGER France
- Conditions
- Glioblastoma
- Keywords
- newly diagnosed Glioblastoma (GBM), Tumor Treating Fields - TTFields
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- NovoCure Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- tdb
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (OS)
Time frame: through study completion, an average of 18 months (mean FU time)
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
5 secondary outcomes
Health Related Quality of life - European Organization for Research and Treatment of Cancer C30 questionnaire
Time frame: 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
Time frame: 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®
Time frame: at start of TTFields treatment, month 2 and month 4 after start of TTFields treatment
Progression Free Survival
Time frame: through study completion, an average of 18 months (mean follow-up time)
Optune Gio® safety profile and deficiencies
Time frame: through study completion, an average of 18 months (mean follow-up time)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by NovoCure Ltd. at 24 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: through study completion, an average of 18 months (mean FU time)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.