Clinical trial · Interventional
Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation
Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation in Elderly Patients With Glioblastoma
NCT04218019CI-TRIAL-00072738GERASwithdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Organizational reasons
Summary
Brief summary (as posted)
The purpose of the study is to assess timing of TTFields use as well as safety, feasibility and preliminary efficacy of treatment with TTFields in elderly patients with newly diagnosed GBM simultaneous to RT/ CRT. The primary aim of the trial is to establish a safely conducted therapy rate higher than 0.8 in the treatment arm.
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 |
|---|---|---|---|
| Newly Diagnosed Glioblastoma in Patients ≥70 Years | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TTFields | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Early Tumor Treating Fields (TTFields, Optune®) treatment
- description
- TTF will be started together with hypofractionated radiotherapy (+/- 5 days) with or without Temozolomide (according to the standard and local physician's decision). Chemoradiotherapy with temozolomide and hypofractionated radiotherapy is regarded as standard therapy and not part of the intervention. In case of chemoradiotherapy temozolomide will be applied according to the standard of the participating trial center. Use of antiemetic and infection prophylaxis will be at the discretion of the investigator.
- interventionNames
- Device: TTFields
- type
- ACTIVE_COMPARATOR
- label
- Late TTF treatment
- description
- Patients will be treated with hypofractionated radiotherapy with or without temozolomide (according to the local standard and physician's decision). Radiotherapy and treatment with temozolomide is regarded as standard therapy and not part of the intervention. In case of chemoradiotherapy temozolomide will be applied according to the standard of the participating trial center. Use of antiemetic and infection prophylaxis will be at the discretion of the investigator. Late TTFields treatment will start 4 weeks after the end of radiotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed, newly diagnosed glioblastoma (astrocytoma WHO grade IV) * Indication for hypofractionated radiotherapy or hypofractionated chemo-radiotherapy with temozolomide * Open biopsy or resection * Craniotomy or intracranial biopsy site must be adequately healed * Informed consent * Age: \>65 years * KPS ≥50% * Ability of subject to understand character and individual consequences of the clinical trial * Written informed consent of participation Exclusion Criteria: * Concurrent participation in another competing interventional clinical trial studying a drug or treatment regimen. * Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry * Prior RT of the brain * Patients who have not yet recovered from acute high-grade toxicities of prior therapies * MRI or TTFields contraindication (e.g. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants, patients with severe skull defects such as a missing bone flap, programmable shunts) * Known hypersensitivity to conductive hydrogels * Pregnant and lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.