Status:
UNKNOWN
A Prospective, Open-label, Single-arm Clinical Study
Lead Sponsor:
Sun Yat-sen University
Conditions:
Recurrent Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
the study is a prospective, single-arm, open-label trial, designed to explore the efficacy and safety of Tumor-Treating Fields (TTFields) combined with second-line chemotherapy treatment in recurrent ...
Detailed Description
PAST CLINICAL EXPERIENCE: The effect of the electric fields generated by the TTFields has been tested in two Ⅲ phase trials in humans(EF-11\&EF-14). The data from these trials suggest TTFields may im...
Eligibility Criteria
Inclusion
- Sign written informed consent prior to any procedure related to the study;
- Recurrence and pathologically confirmed WHO Grade IV glioblastoma (GBM);
- The tumor is located in the supratentorial area
- Age ≥18 years;
- Received radiotherapy and maintenance treatment with temozolomide;
- Expected survival time: \> 3 months;
- KPS score ≥60;
- Ability to comply with the plan;
Exclusion
- Other clinical trials are being tried
- Had major surgery within 4 weeks before the start of the study or had not recovered after the surgery
- Received radiotherapy within 4 weeks before the study
- Received chemotherapy within 4 weeks before the study
- Women during pregnancy;
- Allergic to hydrogels;
- There are important implants in the body, such as pacemaker, defibrillator, shunt tube, deep brain stimulator, etc.;
- Patients with significantly increased intracranial pressure (shifted \>5mm in imaging midline, obvious papilloma, nausea, vomiting, and decreased consciousness)
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04689087
Start Date
April 1 2020
End Date
July 1 2022
Last Update
December 30 2020
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000