Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346821
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-03-29
Brief Title:
Tumor Treating Fields for Newly Diagnosed Glioblastoma Two Emulated Trials With Chinese Multi-Hospital Based Real-World Data
Sponsor:
Sichuan University
Organization:
Sichuan University
Study Overview
Official Title:
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 concomitantadjuvant 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
The efficacy of Optune as an concomitantadjuvant 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 concomitantadjuvant 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
The efficacy of Optune as an concomitantadjuvant 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None