Tumor Treating Fields for Newly Diagnosed Glioblastoma: Two Emulated Trials With Chinese Multi-Hospital Based Real-World Data

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06346821
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sichuan University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lei Liu, PhD, MD
Principal Investigator Affiliation	West China Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma Multiforme

Additional Details

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.

Arms & Interventions

Arms

: TTFields-Total

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.

: Active Comparator: Temozolomide alone

Patients receive RT and TMZ alone, followed by maintenance TMZ.

: TTFields-concomitant

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.

: TTFields-adjuvant

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.

Interventions

Device: - Optune® (Tumor Treating Fields)

TTFields at 200 kHz to the brain using the Optune® System

Contact a Trial Team

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International Sites

West China Hospital, Chengdu, Sichuan, China

Status

Recruiting

Address

West China Hospital

Chengdu, Sichuan, 610041

Site Contact

Lei Liu, PhD, MD

liuleihx@gmail.com

+8618980606231

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