GliomaECTG001NCT04902586
Effect of Radiotherapy Concurrent of TTFields in Patients With Glioblastoma
A study testing TTFields in people with Glioma and Glioblastoma, run by Zhongnan Hospital at 1 site in China.
Trial summary
TTFields has been approved by the FDA for the treatment of patients with glioblastoma multiforme. However, the clinical effect and safety of radiotherapy concurrent of TTFields is not definite. In this study, the investigators conduct a phase II clinical trial to evaluate the efficacy and safety of this strategy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioma, Glioblastoma
- What is being tested?
- TTFields
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2021to 19 Jul 2022
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- performance status of 0-1 (Eastern Cooperative Oncology Group performance status)
- histologically confirmed glioblastoma
- no cerebrospinal fluid and distant metastatic disease.
Who cannot join
- with a history of brain radiotherapy
- severe hepatic and renal dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongnan hospital
Wuhan, Hubei
Yahua Zhong, phd, 08602767813154, doctorzyh73@163.com
About this study
Official title: The Clinical Effect and Safety of Radiotherapy Concurrent of TTFields in the Treatment of Post-operation Patients With Glioblastoma.
TTFields has been approved by the FDA for the treatment of patients with glioblastoma multiforme. However, the clinical effect and safety of radiotherapy concurrent of TTFields is not definite. In this study, the investigators conduct a phase II clinical trial to evaluate the efficacy and safety of this strategy.
Read the detailed description
the investigators plan to recruit 30 patients to evaluate the efficacy and safety of this strategy.
- Conditions
- Glioma, Glioblastoma
- Being tested
- TTFields
- Keywords
- glioblastoma, TTFields, radiotherapy
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTFieldsDevice
The TTFields, consisting of low-intensity, 200 kHz frequency, alternating electric fields, was delivered (≥ 18 hours/d) via 4 transducer arrays on the shaved scalp and connected to a portable device.
| Study group | Role | What they receive |
|---|---|---|
| E group | Experimental | All patients received chemoradiotherapy (CRT) ( PTV-GTV: 60Gy at 2.0Gy per fraction, 5 fractions per week for 6 weeks; PTV-CTV: 54Gy at 1.8Gy per fraction, 5 fractions per week for 6 weeks) with a Temozolomide (TMZ) regimen（75mg/m2 per day during RT）and TTFields therapy during RT. The TTFields therapy started on the day the radiotherapy started. Receives: Device: TTFields |
| C group | No intervention | All patients received chemoradiotherapy (CRT) ( PTV-GTV: 60Gy at 2.0Gy per fraction, 5 fractions per week for 6 weeks; PTV-CTV: 54Gy at 1.8Gy per fraction, 5 fractions per week for 6 weeks) with a Temozolomide (TMZ) regimen（75mg/m2 per day during RT） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
the length of time after primary treatment for glioblastoma ends that the patient survives without any signs or symptoms of glioblastoma.
Measured: 1 year
Secondary outcomes (1)
Overall survival
The length of time from the date of diagnosis to death from cancer
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start19 Jun 2021 (estimated)
- Primary completion19 Dec 2021 (estimated)
- Study completion19 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianyin Huang, MD, Study chair, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902586
- Sponsor's protocol ID
- ZhongnanH ECTG001
- Acronym
- ECTG001
- Status last verified
- May 2021
- First submitted
- 19 May 2021
- Last updated
- 26 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effect and Safety of Radiotherapy Concurrent of TTFields in the Treatment of Post-operation Patients With Glioblastoma.
- ClinicalTrials.gov ID
- NCT04902586
- Acronym / sponsor ID
- ECTG001 / ZhongnanH ECTG001
- Conditions
- Glioma, Glioblastoma
- Keywords
- glioblastoma, TTFields, radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 19 Jun 2021 (estimated)
- Primary completion
- 19 Dec 2021 (estimated)
- Study completion
- 19 Jul 2022 (estimated)
- First posted
- 26 May 2021 (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.
TTFields has been approved by the FDA for the treatment of patients with glioblastoma multiforme. However, the clinical effect and safety of radiotherapy concurrent of TTFields is not definite. In this study, the investigators conduct a phase II clinical trial to evaluate the efficacy and safety of this strategy.
Detailed description
the investigators plan to recruit 30 patients to evaluate the efficacy and safety of this strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E group | Experimental | Device: TTFieldsAll patients received chemoradiotherapy (CRT) ( PTV-GTV: 60Gy at 2.0Gy per fraction, 5 fractions per week for 6 weeks; PTV-CTV: 54Gy at 1.8Gy per fraction, 5 fractions per week for 6 weeks) with a Temozolomide (TMZ) regimen（75mg/m2 per day during RT）and TTFields therapy during RT. The TTFields therapy started on the day the radiotherapy started. |
| C group | No intervention | –All patients received chemoradiotherapy (CRT) ( PTV-GTV: 60Gy at 2.0Gy per fraction, 5 fractions per week for 6 weeks; PTV-CTV: 54Gy at 1.8Gy per fraction, 5 fractions per week for 6 weeks) with a Temozolomide (TMZ) regimen（75mg/m2 per day during RT） |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- performance status of 0-1 (Eastern Cooperative Oncology Group performance status)
- histologically confirmed glioblastoma
- no cerebrospinal fluid and distant metastatic disease.
Key exclusion criteria (2 listed)
- with a history of brain radiotherapy
- severe hepatic and renal dysfunction
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 |
|---|---|---|
| TTFieldsThe TTFields, consisting of low-intensity, 200 kHz frequency, alternating electric fields, was delivered (≥ 18 hours/d) via 4 transducer arrays on the shaved scalp and connected to a portable device. | Device | E group |
Primary outcome
Disease-free survival
Time frame: 1 year
the length of time after primary treatment for glioblastoma ends that the patient survives without any signs or symptoms of glioblastoma.
1 secondary outcome
Overall survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Individual participant dataSharing planned: No
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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.
Jianyin Huang, MD study chair
Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TTFields in people with Glioma and Glioblastoma, run by Zhongnan Hospital 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yahua Zhong, PHD (08602767813154, doctorzyh73@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 1 year). 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 26 May 2021; AzTrials last refreshed its copy on 8 Nov 2026.