Effect of Radiotherapy Concurrent of TTFields in Patients With Glioblastoma
ECTG001
The Clinical Effect and Safety of Radiotherapy Concurrent of TTFields in the Treatment of Post-operation Patients With Glioblastoma.
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2021
CompletedFirst Posted
Study publicly available on registry
May 26, 2021
CompletedStudy Start
First participant enrolled
June 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2022
CompletedMay 26, 2021
May 1, 2021
6 months
May 19, 2021
May 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free survival
the length of time after primary treatment for glioblastoma ends that the patient survives without any signs or symptoms of glioblastoma.
1 year
Secondary Outcomes (1)
Overall survival
2 years
Study Arms (2)
E group
EXPERIMENTALAll 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 INTERVENTIONAll 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）
Interventions
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.
Eligibility Criteria
You may qualify if:
- performance status of 0-1 (Eastern Cooperative Oncology Group performance status)
- histologically confirmed glioblastoma
- no cerebrospinal fluid and distant metastatic disease.
You may not qualify if:
- with a history of brain radiotherapy
- severe hepatic and renal dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongnan hospital
Wuhan, Hubei, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jianyin Huang, MD
Wuhan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2021
First Posted
May 26, 2021
Study Start
June 19, 2021
Primary Completion
December 19, 2021
Study Completion
July 19, 2022
Last Updated
May 26, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share