NovoTTF-200A Device in Treating Patients With Newly Diagnosed High Risk Oligodendroglioma
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03353896|
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anaplastic Oligodendroglioma Oligoastrocytoma Oligodendroglioma||Device: Wear novoTTF-200A Procedure: Quality-of-Life Assessment||Not Applicable|
I. To describe the safety and tolerability of the TTFields treatment in patients with newly diagnosed high risk oligodendroglioma following standard of care treatment.
I. To estimate the proportion of patients who tolerated 75% of treatment goal at months 6, 12, 24.
II. To estimate the progression free survival time. III. To assess quality of life. IV. To assess whether or not there is a correlation between genomics and the efficacy of the TTFields treatment.
Beginning 4-8 weeks after standard of care treatment, patients wear NovoTTF-200A device over 18 hours daily (QD). Treatment continues for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2 months and then monthly thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Trial of NovoTTF -200A (TTFields) in Patients With Newly Diagnosed High Risk Oligodendrogliomas|
|Actual Study Start Date :||December 15, 2017|
|Estimated Primary Completion Date :||December 15, 2019|
|Estimated Study Completion Date :||December 15, 2020|
Experimental: Treatment (medical device)
Beginning 4-8 weeks after standard of care treatment, patients wear NovoTTF-200A device over 18 hours QD. Treatment continues for up to 24 months in the absence of disease progression or unacceptable toxicity.
Device: Wear novoTTF-200A
Wear novoTTF-200A device
Other Name: Medical Devices
Procedure: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
- Safety and Tolerability of the NovoTTFields treatment in patients with high risk oligodendroglioma [ Time Frame: Up to 2 months after treatment ]Number of patients with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.03
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): NCT03353896
|Contact: Sandy Leong, RNfirstname.lastname@example.org|
|United States, California|
|USC / Norris Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Sandy Leong, RN 323-442-7532 email@example.com|
|Principal Investigator: Thomas C. Chen, MD|
|Principal Investigator:||Thomas Chen, MD||University of Southern California|