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NCT04902586 Clinical Trial

Effect of Radiotherapy Concurrent of TTFields in Patients With Glioblastoma

Glioblastoma Clinical Trial

— ECTG001  

Official title:
The Clinical Effect and Safety of Radiotherapy Concurrent of TTFields in the Treatment of Post-operation Patients With Glioblastoma.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04902586
Other study ID # ZhongnanH ECTG001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 19, 2021
Est. completion date July 19, 2022

Study information
Verified date May 2021
Source Zhongnan Hospital
Contact Yahua Zhong, PHD
Phone 08602767813154
Email doctorzyh73@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Description:

the investigators plan to recruit 30 patients to evaluate the efficacy and safety of this strategy.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date July 19, 2022
Est. primary completion date December 19, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• TTFields
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.

Locations
Country Name City State
China Zhongnan hospital Wuhan Hubei

Sponsors (1)
Lead Sponsor Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Overall survival The length of time from the date of diagnosis to death from cancer 2 years
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