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Effect of NovoTTF-100A in Recurrent Glioblastoma Multiforme (GBM)

NCT00379470 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2012-05-01

No results posted yet for this study

Summary

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).

Conditions

  • Recurrent Glioblastoma Multiforme

Interventions

DEVICE

NovoTTF-100A

multiple four-week courses of continuous NovoTTF-100A treatment

Sponsors & Collaborators

  • NovoCure Ltd.

    lead INDUSTRY

Principal Investigators

  • Phillip Gutin, MD · Memorial Sloan Kettering Cancer Center

  • Roger Stupp, MD · University of Lausanne Hospital - Multidisciplinary Oncology Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-11-30
Completion
2011-01-31

Countries

  • United States
  • Austria
  • Czechia
  • France
  • Germany
  • Israel
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00379470 on ClinicalTrials.gov