A Prospective, Open-label, Single-arm Clinical Study
1 other identifier
interventional
40
1 country
1
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 glioblastoma multiforme (GBM) , TTFields is an portable, battery operated device for chronic treatment of patients with recurrent or progressive glioblastoma multiforme (GBM) using alternating electric fields
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2020
Typical duration for not_applicable
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
Study Start
First participant enrolled
April 1, 2020
CompletedFirst Submitted
Initial submission to the registry
December 8, 2020
CompletedFirst Posted
Study publicly available on registry
December 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedDecember 30, 2020
December 1, 2020
1.2 years
December 8, 2020
December 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
OS6
Overall survival at 6 months
6 months
Secondary Outcomes (4)
Overall survival at 12 months (OS12)
12 months
overall survival OS(refers to the time from enrollment to tumor disease death from various causes)
2 years
Progression-free survival PFS
2 years
security
2 years
Study Arms (1)
Second line conventional treatment
EXPERIMENTALInterventions
For patients with relapsed GBM, before receiving electric field treatment, the patient can be re-operated, and TTFields+BPC chemotherapy is used after surgery
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yonggao Mu
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of neurosurgery department
Study Record Dates
First Submitted
December 8, 2020
First Posted
December 30, 2020
Study Start
April 1, 2020
Primary Completion
July 1, 2021
Study Completion
July 1, 2022
Last Updated
December 30, 2020
Record last verified: 2020-12