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Sponsored by: |
NovoCure Ltd. |
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Information provided by: | NovoCure Ltd. |
ClinicalTrials.gov Identifier: | NCT00379470 |
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) |
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):
Principal Investigator: | Phillip Gutin, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Roger Stupp, MD | University of Lausanne Hospital - Multidisciplinary Oncology Center |
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 |
Neuroectodermal Tumors Brain Neoplasms Glioblastoma Astrocytoma Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Glioblastoma Multiforme Glioma Recurrence Neoplasms, Glandular and Epithelial |
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 |