NCT06346821

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 181 (actual)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DEVICE	Optune® (Tumor Treating Fields)	TTFields at 200 kHz to the brain using the Optune® System

Timeline

• Start date: 2022-11-22
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2024-04-04
• Last updated: 2024-07-03

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study