Clinical trial · Observational
TTFields General Routine Clinical Care in ndGBM Patients: a French Prospective Non-Interventional Study (TIGER France)
Tumor Treating Fields General Routine Clinical Care in Newly Diagnosed Glioblastoma Patients: a French Prospective Non-Interventional Study - TIGER France
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- through study completion, an average of 18 months (mean FU time)
- description
- 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
Secondary outcomes (5)
- measure
- Health Related Quality of life - European Organization for Research and Treatment of Cancer C30 questionnaire
- timeFrame
- at start of TTFields treatment, at month 2, month 4, month 6, month 12 and month 18 after start of TTFields treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available