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| Sponsor: | NovoCure Ltd. |
|---|---|
| Information provided by: | NovoCure Ltd. |
| ClinicalTrials.gov Identifier: | NCT00379470 |
Purpose
The study is a randomized, controlled trial, designed to test the efficacy and safety of a new medical device, the NovoTTF-100A. The device is an experimental, portable, battery operated device for chronic treatment of patients with recurrent or progressive glioblastoma multiforme (GBM) using alternating electric fields (termed TTFields).
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent Glioblastoma Multiforme |
Device: NovoTTF-100A |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Prospective, Multi-Center Trial of NovoTTF-100A Compared to Best Standard of Care in Patients With Progressive or Recurrent GBM |
| Enrollment: | 236 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Significant co-morbidities (within 4 weeks prior to enrollment):
Contacts and Locations
Show 25 Study Locations| Principal Investigator: | Phillip Gutin, MD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Roger Stupp, MD | University of Lausanne Hospital - Multidisciplinary Oncology Center |
More Information
| Responsible Party: | NovoCure ( Mike Ambrogi ) |
| Study ID Numbers: | EF-11 |
| Study First Received: | September 20, 2006 |
| Last Updated: | May 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00379470 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Brain tumor Treatment Minimal toxicity GBM |
Glioblastoma Recurrent TTFields |
|
Glioblastoma Disease Attributes Neoplasms by Histologic Type Astrocytoma Neoplasms, Nerve Tissue Recurrence Neuroectodermal Tumors |
Neoplasms Pathologic Processes Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial |