TTFields Together With Temozolomide and Radiotherapy in Patients With Newly Diagnosed GBM
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03780569|
Recruitment Status : Active, not recruiting
First Posted : December 19, 2018
Last Update Posted : December 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Device: NovoTTF-200A Radiation: Radiotherapy Drug: Temozolomide||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Trial of NovoTTF-200A Together With Temozolomide and Radiotherapy in Patients With Newly Diagnosed GBM|
|Actual Study Start Date :||April 27, 2017|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
Patients will receive multiple 1 month courses of continuous NovoTTF-200A treatment together with standard Radiotherapy/Temozolomide followed by maintenance Temozolomide.
Patients receive continuous TTFields treatment using the NovoTTF-200A device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the scalp. The treatment enables the patient to maintain regular daily routine.
60Gy given in 30 2Gy fractions concomitant to temozolomide
Temozolomide(TMZ) will be administered at 75 mg/m^2 concomitant to radiotherapy(RT) and NovoTTF-200A.
Maintenance treatment is to begin about 4 weeks after the end of TMZ/RT/NovoTTF-200A. TMZ is administered at the conventional dosing regimen for 5 days, every 28 days (i.e. 5 days of therapy, 23 days of rest). Cycle 1 is to be given at a dose of 150 mg/m^2 p.o. daily x 5 days, dose to be escalated to 200 mg/m^2 in the absence of toxicity.
- Safety of concomitant Radiotherapy/Temozolomide with NovoTTF-200A: The incidence of Radiotherapy treatment delays during concomitant Radiotherapy/Temozolomide/NovoTTF-200A will be documented including severity and relationship to NovoTTF-200A. [ Time Frame: 2 years ]The incidence of Radiotherapy treatment delays during concomitant Radiotherapy/Temozolomide/NovoTTF-200A will be documented including severity and relationship to NovoTTF-200A.
- Progression free survival [ Time Frame: 2 years ]
- Overall survival [ Time Frame: 2 years ]
- Adverse events, severity and frequency [ Time Frame: 2 years ]Safety of NovoTTF-200A treatment based on the incidence and severity of adverse events and toxicities.
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): NCT03780569
|Tel Aviv Sourasky Medical Center|
|Tel Aviv, Israel|