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GlioblastomaPhase 1NCT02893137

Enhancing Optune Therapy With Targeted Craniectomy

A Phase 1 study testing Optune and Craniectomy in people with Glioblastoma, run by Aarhus University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
Optune and Craniectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteDenmark
Study dates
1 Oct 2016to 31 May 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Aarhus University Hospital

    Aarhus C, Aarhus, 8000

Other trials in Denmark

About this study

Official title: 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.

Conditions
Glioblastoma
Being tested
Optune, Craniectomy
Keywords
Tumour treating fields, Optune, Craniectomy, TTFields
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OptuneDevice

    Also called NovoTTF-100A, Tumor treating fields, TTFields

    For further information see www.optune.com

  • CraniectomyProcedure or surgery

    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.

Study groups in NCT02893137
Study groupRoleWhat they receive
Craniectomy and OptuneExperimentalPatients 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.
Receives: Device: Optune; Procedure: Craniectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of serious adverse events

    Based on CTCAE.

    Measured: Through study completion, an average of 18 months.

Secondary outcomes (8)

  1. Overall survival

    Measured: Through study completion, an average of 18 months.

  2. Progression free survival

    Measured: Through study completion, an average of 18 months.

  3. Progression free survival at six months

    Measured: Through study completion, an average of 18 months.

  4. % 1-year survival

    Measured: Through study completion, an average of 18 months.

  5. Objective response rate

    Assessed by RANO criteria

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

  6. Quality of life

    Assessed by EORTC QLQ-30 and QLQ-BN20

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

  7. Cumulative corticosteroid dosage

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

  8. Karnofsky performance score

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2016 (estimated)
  2. Study start1 Oct 2016
  3. Primary completion31 May 2019
  4. Study completion31 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02893137
Sponsor's protocol ID
54762
Status last verified
Aug 2016
First submitted
22 Aug 2016
Last updated
27 Nov 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30641498

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Optune and Craniectomy in people with Glioblastoma, run by Aarhus University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of serious adverse events (time frame: Through study completion, an average of 18 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02893137, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.

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