Back to resultsEffect of Radiotherapy Concurrent of TTFields in Patients With Glioblastoma (ECTG001)
Primary Purpose
Glioma, Glioblastoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TTFields
Sponsored by
About this trial
This is an interventional treatment trial for Glioma focused on measuring glioblastoma, TTFields, radiotherapy
Eligibility Criteria
Inclusion Criteria:
- performance status of 0-1 (Eastern Cooperative Oncology Group performance status)
- histologically confirmed glioblastoma
- no cerebrospinal fluid and distant metastatic disease.
Exclusion Criteria:
- with a history of brain radiotherapy
- severe hepatic and renal dysfunction
Sites / Locations
- Zhongnan hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
E group
C group
Arm Description
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.
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）
Outcomes
Primary Outcome Measures
Disease-free survival
the length of time after primary treatment for glioblastoma ends that the patient survives without any signs or symptoms of glioblastoma.
Secondary Outcome Measures
Overall survival
The length of time from the date of diagnosis to death from cancer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04902586
Brief Title
Effect of Radiotherapy Concurrent of TTFields in Patients With Glioblastoma
Acronym
ECTG001
Official Title
The Clinical Effect and Safety of Radiotherapy Concurrent of TTFields in the Treatment of Post-operation Patients With Glioblastoma.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 19, 2021 (Anticipated)
Primary Completion Date
December 19, 2021 (Anticipated)
Study Completion Date
July 19, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongnan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
the investigators plan to recruit 30 patients to evaluate the efficacy and safety of this strategy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Glioblastoma
Keywords
glioblastoma, TTFields, radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
E group
Arm Type
Experimental
Arm Description
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.
Arm Title
C group
Arm Type
No Intervention
Arm Description
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）
Intervention Type
Device
Intervention Name(s)
TTFields
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease-free survival
Description
the length of time after primary treatment for glioblastoma ends that the patient survives without any signs or symptoms of glioblastoma.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall survival
Description
The length of time from the date of diagnosis to death from cancer
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
performance status of 0-1 (Eastern Cooperative Oncology Group performance status)
histologically confirmed glioblastoma
no cerebrospinal fluid and distant metastatic disease.
Exclusion Criteria:
with a history of brain radiotherapy
severe hepatic and renal dysfunction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yahua Zhong, PHD
Phone
08602767813154
Email
doctorzyh73@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianyin Huang, MD
Organizational Affiliation
Wuhan University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongnan hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yahua Zhong, phd
Phone
08602767813154
Email
doctorzyh73@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Radiotherapy Concurrent of TTFields in Patients With Glioblastoma
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