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| Sponsor: | NovoCure Ltd. |
|---|---|
| Information provided by (Responsible Party): | 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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Best Standard of Care
Patients randomized to the BSC group will be treated with one chemotherapy according to the BSC practiced at each center.
|
Device: NovoTTF-100A
multiple four-week courses of continuous NovoTTF-100A treatment
|
| Experimental: NovoTTF-100A |
Device: NovoTTF-100A
multiple four-week courses of continuous NovoTTF-100A treatment
|
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 Ltd. |
| ClinicalTrials.gov Identifier: | NCT00379470 History of Changes |
| Other Study ID Numbers: | EF-11 |
| Study First Received: | September 20, 2006 |
| Last Updated: | April 29, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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Brain tumor Treatment Minimal toxicity GBM |
Glioblastoma Recurrent TTFields |
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |