NCT02893137

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
23 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

November 27, 2019

Status Verified

August 1, 2016

Enrollment Period

2.7 years

First QC Date

August 22, 2016

Last Update Submit

November 25, 2019

Conditions

Glioblastoma

Keywords

Tumour treating fieldsOptuneCraniectomyTTFields

Outcome Measures

Primary Outcomes (1)

  • Frequency of serious adverse events

    Based on CTCAE.

    Through study completion, an average of 18 months.

Secondary Outcomes (8)

  • Overall survival

    Through study completion, an average of 18 months.

  • Progression free survival

    Through study completion, an average of 18 months.

  • Progression free survival at six months

    Through study completion, an average of 18 months.

  • % 1-year survival

    Through study completion, an average of 18 months.

  • Objective response rate

    Will be assessed at baseline and upon clinical follow-up every 3rd month until exclusion. Data will be presented at trial termination.

  • +3 more secondary outcomes

Study Arms (1)

Craniectomy and Optune

EXPERIMENTAL

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: OptuneProcedure: Craniectomy

Interventions

OptuneDEVICE

For further information see www.optune.com

Also known as: NovoTTF-100A, Tumor treating fields, TTFields
Craniectomy and Optune
CraniectomyPROCEDURE

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.

Craniectomy and Optune

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus C, Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Korshoej AR, Sorensen JCH, von Oettingen G, Poulsen FR, Thielscher A. Optimization of tumor treating fields using singular value decomposition and minimization of field anisotropy. Phys Med Biol. 2019 Feb 8;64(4):04NT03. doi: 10.1088/1361-6560/aafe54.

    PMID: 30641498DERIVED

MeSH Terms

Conditions

Glioblastoma

Interventions

Craniotomy

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Neurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Anders R Korshoej, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2016

First Posted

September 8, 2016

Study Start

October 1, 2016

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

November 27, 2019

Record last verified: 2016-08

Locations

DK(1)