Glioblastoma MultiformeNCT06346821
Tumor Treating Fields for Newly Diagnosed Glioblastoma: Two Emulated Trials With Chinese Multi-Hospital Based Real-World Data
An observational study of Glioblastoma Multiforme, run by Sichuan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Optune® (Tumor Treating Fields)
- Type of treatment
- Medical device
- How many people
- 181 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2022to 1 Apr 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are diagosed and whose surgery and radiotheraoy are finished in West China Hospital, Sichuan Cancer Hospital, Shenzhen People's Hospital, Henan Cancer Hospital, The First Affiliated Hospital of Xi'an Jiaotong University, The First Affiliated Hospital of Zhengzhou University
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Optune® (Tumor Treating Fields)
- Keywords
- Glioblastoma, Tumor Treating Fields, Real-world, Concomitant, Adjuvant, Overall survival
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optune® (Tumor Treating Fields)Device
TTFields at 200 kHz to the brain using the Optune® System
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Optune® (Tumor Treating Fields) | |
| 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. Receives: Device: Optune® (Tumor Treating Fields) | |
| 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. Receives: Device: Optune® (Tumor Treating Fields) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Survival will be measured from the time of randomization until date patient is alive.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start22 Nov 2022
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 181 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongzheng Xiang, Sichuan University
- Investigators
- Lei Liu, PhD, MD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346821
- Sponsor's protocol ID
- WestChinaGBMTTFieldsV1.0
- Status last verified
- Jul 2024
- First submitted
- 29 Mar 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06346821
- Acronym / sponsor ID
- WestChinaGBMTTFieldsV1.0
- Conditions
- Glioblastoma Multiforme
- Keywords
- Glioblastoma, Tumor Treating Fields, Real-world, Concomitant, Adjuvant, Overall survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TTFields-Total | – | Device: 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. |
| Active Comparator: Temozolomide alone | – | –Patients receive RT and TMZ alone, followed by maintenance TMZ. |
| TTFields-concomitant | – | Device: 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. |
| TTFields-adjuvant | – | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are diagosed and whose surgery and radiotheraoy are finished in West China Hospital, Sichuan Cancer Hospital, Shenzhen People's Hospital, Henan Cancer Hospital, The First Affiliated Hospital of Xi'an Jiaotong University, The First Affiliated Hospital of Zhengzhou University
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optune® (Tumor Treating Fields)TTFields at 200 kHz to the brain using the Optune® System | Device | TTFields-Total, TTFields-adjuvant, TTFields-concomitant |
Primary outcome
Overall Survival (OS)
Time frame: 5 years
Survival will be measured from the time of randomization until date patient is alive.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Liu, PhD, MD principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma Multiforme, run by Sichuan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.