Recurrent Study Design

In recurrent GBM,

The efficacy and safety of Optune Gio monotherapy were compared with physician's choice of chemotherapy*

EF-11 phase 3 pivotal trial—Optune Gio vs physician’s choice of chemotherapy, including bevacizumab1

*Therapy options were the physician's best choice for chemotherapy. The best available therapy was prescribed according to local practice and depending on
 prior treatment exposure.  

  • Approximately 20% of patients in each EF-11 treatment arm had failed a prior bevacizumab-containing regimen1

Key efficacy endpointsKey efficacy endpoints1,2

  • Primary endpoint
    • OS


  • Secondary endpoints
    • PFS
    • 1-year survival
    • Median time to progression
    • Radiological response rates
    • QoL

Key inclusion criteria1,2

  • Not a candidate for further radiotherapy or additional resection of residual tumor
  • Subjects with disease progression (by McDonald criteria, ie, >25% or new lesion) documented by CT or MRI within 4 weeks prior to enrollment 
  • KPS ≥70 

Key exclusion criteria1,2

  • Significant comorbidities within 4 weeks prior to enrollment 
  • Surgery for recurrence within 4 weeks 
  • Infratentorial tumor 
  • Prior radiation or chemotherapy in the past 4 weeks 
  • Implanted pacemaker, defibrillator, or deep brain stimulator, or documented clinically significant arrhythmias  

EF-11: Key baseline characteristics1,2

Intent to treat (ITT) population 

Single agent or combination regimens 

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Practice Support

Multiple listings possible, some agents given in combination.

BCNU, carmustine; CCNU, lomustine; CT, computed tomography; GBM, glioblastoma; KPS, Karnofsky Performance Score; MRI, magnetic resonance imaging; OS, overall survival; PCV, procarbazine + lomustine + vincristine; PFS, progression-free survival; PFS6, progression-free survival at 6 months; QoL, quality of life.

References: 1. Stupp R, Wong ET, Kanner AA, et al. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012;48(14):2192-2202. 2. Optune Instructions for Use. Novocure 2019. 3. Stupp R, Wong ET, Kanner AA, et al. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Supplemenary table 1. Accessed October 18, 2023. Eur J Cancer. 2012;48(14):2192-2202.

Indications For Use


Optune GioTM is intended as a treatment for adult patients (22 years of age or older) with histologically confirmed glioblastoma multiforme (GBM).


Optune Gio with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery, and completion of radiation therapy together with concomitant standard of care chemotherapy.


For the treatment of recurrent GBM, Optune Gio is indicated following histologically or radiologically confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

Important Safety Information



Do not use Optune Gio in patients with an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune Gio together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune Gio together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune Gio ineffective.


Do not use Optune Gio in patients that are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune Gio may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions such as shock and respiratory failure.


Warnings and precautions


Optune Gio can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure (the device manufacturer).


Do not prescribe Optune Gio for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune Gio in these populations have not been established.


The most common (≥10%) adverse events involving Optune Gio in combination with temozolomide were thrombocytopenia, nausea, constipation, vomiting, fatigue, medical device site reaction, headache, convulsions, and depression.


The most common (≥10%) adverse events seen with Optune Gio monotherapy were medical device site reaction and headache.
The following adverse reactions were considered related to Optune Gio when used as monotherapy: medical device site reaction, headache, malaise, muscle twitching, fall, and skin ulcer.


Use of Optune Gio in patients with an inactive implanted medical device in the brain has not been studied for safety and effectiveness, and use of Optune Gio in these patients could lead to tissue damage or lower the chance of Optune Gio being effective.


If the patient has an underlying serious skin condition on the scalp, evaluate whether this may prevent or temporarily interfere with Optune Gio treatment.


Please click here to see the Optune GioTM Instructions For Use for complete information regarding the device's indications, contraindications, warnings, and precautions.

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US-OPG-00197v1.0 November 2023