Clinical trial · Observational
Tumor Treating Fields for Newly Diagnosed Glioblastoma: Two Emulated Trials With Chinese Multi-Hospital Based Real-World Data
Optimizing Tumor Treating Fields Intervention Timing for Newly Diagnosed Glioblastoma: Insights From Two Emulated Trials With Chinese Multi-Hospital Based Real-World Data
- 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 goal of this observational study is to learn about the effectiveness of Optune® (Tumor Treating Fields) in newly diagnosed glioblastoma (GBM) in China. The main question it aims to answer are: * The efficacy of Optune® as an concomitant/adjuvant to radiation therapy (RT) and temozolomide (TMZ) alone in the treatment of newly diagnosed GBM patients. * The effectiveness of Optune® given concomitantly with RT and TMZ in newly diagnosed GBM patients, compared to RT and TMZ alone. Participants will: * Receive or not receive TTFields. * Concomitantly or adjuvantly receive TTFields.
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 Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Optune® (Tumor Treating Fields) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- TTFields-Total
- description
- Patients receive standard RT + TMZ, followed by maintenance TMZ, with Optune® starts during peri-radiotherapy period (2 month before to 3 months after radiotherapy). The duration of TTFields lasts for at least 2 months.
- interventionNames
- Device: Optune® (Tumor Treating Fields)
- label
- Active Comparator: Temozolomide alone
- description
- Patients receive RT and TMZ alone, followed by maintenance TMZ.
- label
- TTFields-concomitant
- description
- Patients receive TTFields at 200 kHz to the brain using the Optune® System together with RT and TMZ, followed by maintenance TMZ concomitant with the Optune® treatment. The duration of TTFields lasts for at least 2 months. If the subject is assigned to this treatment arm, Optune® therapy will begin no later than the 7th day of RT and TMZ treatment.
- interventionNames
- Device: Optune® (Tumor Treating Fields)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed diagnosis of GBM according to WHO classification criteria. 2. Age ≥ 18 years. 3. Recovered from maximal debulking surgery. 4. Karnofsky performance status ≥ 60. 5. Planned treatment with RT/TMZ followed by maintenance TMZ. Exclusion Criteria: 1. Progressive disease (per investigator's assessment). 2. Infratentorial or leptomeningeal disease. 3. Significant co-morbidities at baseline which would preclude maintenance RT or TMZ treatment. 4. Any serious surgical/post-operative condition that may risk the patient according to the investigator.
References
Publications (0)
Data not yet available