Tumor Treating Fields for Newly Diagnosed Glioblastoma: Two Emulated Trials With Chinese Multi-Hospital Based Real-World Data
- Conditions
- Glioblastoma Multiforme
- Interventions
- Device: Optune® (Tumor Treating Fields)
- Registration Number
- NCT06346821
- Lead Sponsor
- Sichuan University
- Brief Summary
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.
- Detailed Description
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:
Step 1:
* Treatment arm I: 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.
* Treatment arm II: Patients receive RT and TMZ alone, followed by maintenance TMZ concomitant.
Step 2:
* Treatment arm I: 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.
* Treatment arm II: Patients receive RT and TMZ alone, followed by maintenance TMZ concomitant with TTFields at 200 kHz to the brain using the Optune® within 3 months after radiotherapy for at least 2 months.
Researchers will compare the overall survival of each arm to see if TTFields demonstrates an improvement in survival outcomes within the Chinese population in real-world practice, and whether this efficacy is further enhanced when combined with RT and TMZ.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 181
- Histologically confirmed diagnosis of GBM according to WHO classification criteria.
- Age ≥ 18 years.
- Recovered from maximal debulking surgery.
- Karnofsky performance status ≥ 60.
- Planned treatment with RT/TMZ followed by maintenance TMZ.
- Progressive disease (per investigator's assessment).
- Infratentorial or leptomeningeal disease.
- Significant co-morbidities at baseline which would preclude maintenance RT or TMZ treatment.
- Any serious surgical/post-operative condition that may risk the patient according to the investigator.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description TTFields-Total Optune® (Tumor Treating Fields) 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. TTFields-adjuvant Optune® (Tumor Treating Fields) Patients receive RT and TMZ alone, followed by maintenance TMZ concomitant with TTFields at 200 kHz to the brain using the Optune® within 3 months after radiotherapy for at least 2 months. TTFields-concomitant Optune® (Tumor Treating Fields) 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.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) 5 years Survival will be measured from the time of randomization until date patient is alive.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
West China Hospital
🇨🇳Chengdu, Sichuan, China