Open-Label Pilot Study of OPTUNE® With High Density Transducer Arrays for the Treatment of Recurrent GBM
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|ClinicalTrials.gov Identifier: NCT04492163|
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : November 24, 2020
This is a prospective, open-label, single arm, historical control pilot study aimed to test the effectiveness and safety of TTFields delivered through high intensity arrays in recurrent glioblastoma.
The Optune® System is an investigational , portable, battery operated medical device in this study delivering 200 kHz TTFields to the brain using high intensity transducer arrays for the treatment of patients at the age of 18 years or older with first or second recurrence of Glioblastoma Multiforme (GBM)
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Device: TTFields||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single group assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open label|
|Official Title:||EF-33: An Open-Label Pilot Study of OPTUNE® (TTFields, 200 Khz) With High Density Transducer Arrays for the Treatment of Recurrent Glioblastoma|
|Actual Study Start Date :||July 14, 2020|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Experimental: Experimental: TTFields
Patients receive continuous TTFields treatment using the Optune® System with high intensity transducer arrays.
TTFields treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine.
- Progression free survival (PFS) [ Time Frame: 18 Months ]PFS will be measured from the date of enrollment to date of progression (in months) based on RANO citeria.
- Overall Survival (OS) [ Time Frame: 18 Months ]Survival will be measured from date of enrollment until date of death.
- Progression Free Survival at 6 months (PFS6) [ Time Frame: 18 Months ]The analysis will be estimated proportions of patients who are progression-free at 6 months based on the RANO criteria following the time of enrollment.
- 1-year and 2-year survival rates [ Time Frame: 24 Months ]The analyses will be performed based on estimated proportions of patients who are alive at one and two years following enrollment.
- Overall radiological response [ Time Frame: 18 Months ]The percentage of patients who had either complete response or partial response per RANO criteria following enrollment
- Severity and frequency of adverse events [ Time Frame: 18 Months ]The analyses will be performed based on the incidence, severity, frequency of adverse events, and their association with study treatments
- Pathological changes in resected GBM tumors following study treatment [ Time Frame: 18 Months ]Pathological changes in the tumors of patients who consented to have pathological analysis of their tumors and also underwent another surgical resection while on the study
- Dependence of Progression Free Survival on TTFields dose delivered to the tumor bed [ Time Frame: 18 months ]
- Dependence of Overall Survival on TTFields dose delivered to the tumor bed [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04492163
|Contact: Antonia Mahnig||+41 41 455 36 firstname.lastname@example.org|
|Principal Investigator:||Josef Vymazal, MD, DSc||Nemocnice Na Homolce (Na Homolce Hospital|