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

This study has been completed.
Information provided by (Responsible Party):
NovoCure Ltd. Identifier:
First received: September 20, 2006
Last updated: April 29, 2012
Last verified: April 2012
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
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

Resource links provided by NLM:

Further study details as provided by NovoCure Ltd.:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 2 years from initiation of accrual ]

Secondary Outcome Measures:
  • Progression free survival at 6 months (PFS6) [ Time Frame: 2 years from initiation of accrual ]
  • Median Time to Disease Progression (TTP) [ Time Frame: 2 years from initiation of accrual ]
  • % 1-year survival [ Time Frame: 2 years from initiation of accrual ]
  • Radiological response (Macdonald criteria) [ Time Frame: 2 years from initiation of accrual ]
  • Quality of life assessment (EORTC QLQ-C30) [ Time Frame: 2 years from initiation of accrual ]
  • Adverse events severity and frequency [ Time Frame: 2 years from initiation of accrual ]

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pathological evidence of GBM using WHO classification criteria.
  • > 18 years of age.
  • Not a candidate for further radiotherapy or additional resection of residual tumor.
  • Patients with disease progression (by Macdonald criteria i.e., > 25% or new lesion) documented by CT or MRI within 4 weeks prior to enrollment
  • Karnofsky scale ≥ 70
  • Life expectancy at least 3 months
  • Participants of childbearing age must use effective contraception.
  • All patients must sign written informed consent.

Exclusion Criteria:

  • Actively participating in another clinical treatment trial
  • Within 4 weeks from surgery for recurrence
  • Within 4 weeks from any prior chemotherapy.
  • Within 4 weeks from radiation therapy
  • Pregnant
  • Significant co-morbidities (within 4 weeks prior to enrollment):

    1. Significant liver function impairment - AST or ALT > 3 times the upper limit of normal
    2. Total bilirubin > upper limit of normal
    3. Significant renal impairment (serum creatinine > 1.7 mg/dL)
    4. Coagulopathy (as evidenced by PT or APTT >1.5 times control in patients not undergoing anticoagulation)
    5. Thrombocytopenia (platelet count < 100 x 103/μL)
    6. Neutropenia (absolute neutrophil count < 1 x 103/μL)
    7. Anemia (Hb < 10 g/L)
    8. Severe acute infection
  • Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias.
  • Infra-tentorial tumor
  • Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00379470

  Show 25 Study Locations
Sponsors and Collaborators
NovoCure Ltd.
Principal Investigator: Phillip Gutin, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Roger Stupp, MD University of Lausanne Hospital - Multidisciplinary Oncology Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: NovoCure Ltd. Identifier: NCT00379470     History of Changes
Other Study ID Numbers: EF-11
Study First Received: September 20, 2006
Last Updated: April 29, 2012

Keywords provided by NovoCure Ltd.:
Brain tumor
Minimal toxicity

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue processed this record on April 28, 2017