Evaluating the use of Optune Gio® in patients with newly diagnosed Glioblastoma in France
Tumor Treating Fields General Routine Clinical Care in Newly Diagnosed Glioblastoma Patients: a French Prospective Non-Interventional Study - TIGER France
This study is testing if the Optune Gio® device can help people with newly diagnosed Glioblastoma live longer and feel better after their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 430 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NovoCure Ltd. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 24 sites (Amiens and 23 other locations) |
| Trial ID | NCT06924099 on ClinicalTrials.gov |
What this trial studies
This prospective multicenter non-interventional study aims to confirm the survival benefit of the Optune Gio® device in patients with newly diagnosed Glioblastoma (GBM) who have completed radiotherapy and concomitant temozolomide (TMZ). The study will measure overall survival (OS) and progression-free survival (PFS), as well as device usage compliance and its impact on quality of life (QoL) in a real-life setting. Participants will be monitored for their daily life experiences and symptom burden, given the aggressive nature of GBM and its associated disabilities.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed GBM who have completed initial radiochemotherapy and are starting maintenance TMZ.
Not a fit: Patients currently participating in other clinical trials or those with significant neurological diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for improved survival and quality of life for patients with newly diagnosed GBM using the Optune Gio® device.
How similar studies have performed: Previous studies have shown success with similar approaches, particularly the pivotal phase III trial that led to the FDA approval of Optune Gio®.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Amiens and 23 other locations
- Chu Amiens Picardie — Amiens, France (Recruiting)
- Institut Sainte-Catherine — Avignon, France (Recruiting)
- Chu Saint Andre — Bordeaux, France (Recruiting)
- Chu Brest Hopital Morvan — Brest, France (Recruiting)
- Hopital Neurologie Pierre Wetrheimer — Bron, France (Recruiting)
- Crlcc Francois Baclesse — Caen, France (Recruiting)
- Centre Lutte Contre Le Cancer Jean Perrin — Clermont-Ferrand, France (Recruiting)
- Crlcc Georges Francois Leclerc — Dijon, France (Recruiting)
- Chu de Grenoble Alpes — La Tronche, France (Recruiting)
- Hopital Roger Salengro — Lille, France (Recruiting)
- Centre Hospitalier La Timone — Marseille, France (Recruiting)
- Institut du Cancer de Montpellier - Val d'Aurelle — Montpellier, France (Recruiting)
- CHU de Nice — Nice, France (Recruiting)
- CHU de Nîmes - HOPITAL CAREMEAU — Nîmes, France (Recruiting)
- Ch Regional Orleans — Orléans, France (Recruiting)
- Hopital Saint Louis — Paris, France (Recruiting)
- Gh Pitie Salpetriere Aphp — Paris, France (Recruiting)
- CRLCC - Centre Eugène Marquis — Rennes, France (Recruiting)
- Crlcc Henri Becquerel — Rouen, France (Recruiting)
- Chu de Saint Etienne — Saint-Priest-en-Jarez, France (Recruiting)
- Hopital Foch — Suresnes, France (Recruiting)
- Hia Sainte Anne — Toulon, France (Recruiting)
- Institut Claudius Regaud — Toulouse, France (Recruiting)
- Institut Gustave Roussy — Villejuif, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.