Enhancing Optune Therapy With Targeted Craniectomy

November 25, 2019 updated by: Aarhus University Hospital

Enhancing Optune Therapy of Recurrent Glioblastoma Multiforme Using Targeted Surgical Skull Remodeling

The present study proposes a new and potentially superior clinical approach to Optune™ therapy of selected glioblastoma patients. The approach is based on combining TTFields with targeted surgical skull remodeling, such as minor craniectomy or a distribution of burr holes, designed for the individual patient. Pre-clinical modeling results suggest that such procedures may enhance the induced electrical field strength by up to ~100% and thereby potentially improve the clinical outcome of treated patients to a significant extent.

The study is an open label phase 1 clinical pilot experiment designed to investigate feasibility, safety and efficacy of the concept. Fifteen patients with first recurrence of glioblastoma will be included in the trial. All patients will receive TTFields therapy with targeted craniotomy and best physician's choice chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Aarhus
      • Aarhus C, Aarhus, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathological evidence of GBM using WHO classification criteria
  • Estimated survival minimum three months
  • Supratentorial tumor
  • Not a candidate for further radiotherapy
  • First disease recurrence in accordance with RANO criteria
  • Karnofsky scale score minimum 70
  • Ability to comply with Optune therapy
  • Tumor characteristics which indicate significant expected benefit from feasible craniotomy or skull remodelling surgery combined with TTFields
  • Focal tumor
  • Most superficial border of tumor or resection cavity closer than 2 cm from brain surface
  • Use of validated anti-conception for female participants in accordance with guidelines provided by the Danish Health and Medicines Authority
  • Signed written consent form

Exclusion Criteria:

  • Pregnancy or nursing. Fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy
  • Less than four weeks since radiation therapy
  • Infratentorial tumor
  • Implanted pacemaker, programmable shunt, defibrillator, deep brain stimulator, other implanted devices in the brain, or documented clinically significant arrhythmias.
  • Uncontrollable symptomatic epilepsy, refractory to standard medication. Epilepsy will not necessarily contraindicate participation in the trial as this is a common complication to the disease. Eligibility will be determined by the examining physician and investigators in conjunction upon careful consideration of patient safety.
  • Contraindications for skull remodelling surgery, e.g. bleeding diathesis or severe infection.
  • Significant co-morbidities (within four weeks prior to enrolment)
  • Significant liver function impairment - ALT > 3 times the upper limit of normal
  • Total bilirubin > upper limit of normal
  • Significant renal impairment (serum creatinine > 1.7 mg/dL)
  • Coagulopathy (as evidenced by PT or APTT > 1.5 times control in normal individuals not undergoing anticoagulation)
  • Thrombocytopenia (platelet count < 100x10^3/μL )
  • Anemia (Hb < 10 g/L)
  • Active participation in another clinical treatment trial

Patients will be regarded as participants when they have signed a consent form and have been found suitable for enrolment by the examining physician, in accordance with the abovecriteria. Patients may receive medication depending on their clinical condition and other diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Craniectomy and Optune
Patients will receive best physician's choice chemotherapy along with Optune therapy and craniotomy surgery. Optune therapy will be administered in the standard configuration and in accordance with current guidelines with the exception of the surgical intervention.
Device: Optune
For further information see www.optune.com
Other Names:
  • TTFields
  • NovoTTF-100A
  • Tumor treating fields
Procedure: Craniectomy
A small hole is placed in the skull between the tumor and the closest Optune electrode. The position and geometry of the craniotomy is determined by computersimulation of the electric field induced by Optune therapy. Craniotomy is a surgical procedure, which is carried out under general anaesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of serious adverse events
Time Frame: Through study completion, an average of 18 months.
Based on CTCAE.
Through study completion, an average of 18 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Through study completion, an average of 18 months.
Through study completion, an average of 18 months.
Progression free survival
Time Frame: Through study completion, an average of 18 months.
Through study completion, an average of 18 months.
Progression free survival at six months
Time Frame: Through study completion, an average of 18 months.
Through study completion, an average of 18 months.
% 1-year survival
Time Frame: Through study completion, an average of 18 months.
Through study completion, an average of 18 months.
Objective response rate
Time Frame: Will be assessed at baseline and upon clinical follow-up every 3rd month until exclusion. Data will be presented at trial termination.
Assessed by RANO criteria
Will be assessed at baseline and upon clinical follow-up every 3rd month until exclusion. Data will be presented at trial termination.
Quality of life
Time Frame: Will be assessed at baseline and upon clinical follow-up every 3rd month until exclusion. Data will be presented at trial termination.
Assessed by EORTC QLQ-30 and QLQ-BN20
Will be assessed at baseline and upon clinical follow-up every 3rd month until exclusion. Data will be presented at trial termination.
Cumulative corticosteroid dosage
Time Frame: Will be assessed at baseline and upon clinical follow-up every 3rd month until exclusion. Data will be presented at trial termination.
Will be assessed at baseline and upon clinical follow-up every 3rd month until exclusion. Data will be presented at trial termination.
Karnofsky performance score
Time Frame: Will be assessed at baseline and upon clinical follow-up every 3rd month until exclusion. Data will be presented at trial termination.
Will be assessed at baseline and upon clinical follow-up every 3rd month until exclusion. Data will be presented at trial termination.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Collaborators

NovoCure Ltd.

Investigators

  • Principal Investigator: Anders R Korshoej, MD, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 54762

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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