Clinical trial · Observational
TTFields In GErmany in Routine Clinical Care
The Use of TTFields for Newly Diagnosed GBM Patients in Germany in Routine Clinical Care - TIGER Study
NCT03258021CI-TRIAL-00049683TIGERunknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this post-authorisation medical device study is to obtain real life data on the use of tumor-treating fields (TTFields) in patients with newly diagnosed GBM in routine clinical care in Germany. Patients with newly diagnosed GBM and clinical indication for TTFields treatment will be enrolled in the study after signing Informed consent to use their data and process it centrally for research purposes. The clinical indication for TTFields is one of the inclusion criteria and is defined prior to inclusion by the treating physician. The patient's decision regarding TTFields treatment is part of the observation and will be assessed within the baseline visit.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TTFields | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- GBM with indication for TTFields
- description
- newly diagnosed GBM with clinical indication for TTFields
- interventionNames
- Device: TTFields
Primary outcomes (7)
- measure
- Time to death of any cause (overall survival (OS)) from diagnosis
- timeFrame
- through study completion, an average of 18 months (mean FU time)
- description
- Time to death of any cause (overall survival (OS)) from diagnosis is measured using the patient data from date of enrollment until the date of death from any cause
- measure
- Number of TTFields treatment-related serious adverse events (SAEs) standardized to one year of FU time
- timeFrame
- through study completion, an average of 18 months (mean follow-up time)
- description
- Number of TTFields treatment-related SAEs standardized to one year of follow-up (FU) is measured using the collection of SAEs during the follow-up period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed histologically confirmed GBM (WHO-Grade IV) * Patient within first 3 cycles of first-line tumor-specific maintenance chemotherapy * ≥ 18 years of age * Clinical indication for TTFields treatment * Given informed consent for use and processing of data Exclusion Criteria: * Present or planned pregnancy * Significant additional neurological disease (e.g. significantly increased intracerebral pressure (ICP) with a significant midline shift of the brain) * Active implanted medical device (e.g. deep brain stimulator) * Documented allergy to conductive hydrogel * Skull defect (e.g. missing bone with no replacement, bullet fragments in the skull)
References
Publications (12)
- BACKGROUNDDolecek TA, Propp JM, Stroup NE, Kruchko C. CBTRUS statistical report: primary brain and central nervous system tumors diagnosed in the United States in 2005-2009. Neuro Oncol. 2012 Nov;14 Suppl 5(Suppl 5):v1-49. doi: 10.1093/neuonc/nos218. No abstract available. PMID 23095881
- BACKGROUNDStupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330. PMID 15758009
- BACKGROUNDStupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669. PMID 26670971
- BACKGROUNDKesari S, Ram Z; EF-14 Trial Investigators. Tumor-treating fields plus chemotherapy versus chemotherapy alone for glioblastoma at first recurrence: a post hoc analysis of the EF-14 trial. CNS Oncol. 2017 Jul;6(3):185-193. doi: 10.2217/cns-2016-0049. Epub 2017 Apr 12. PMID 28399638
- BACKGROUNDStupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbaly V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.