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Enhancing Optune Therapy With Targeted Craniectomy

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ClinicalTrials.gov Identifier: NCT02893137
Recruitment Status : Unknown
Verified August 2016 by University of Aarhus ( Aarhus University Hospital ).
Recruitment status was:  Recruiting
First Posted : September 8, 2016
Last Update Posted : January 10, 2017
Sponsor:
Collaborator:
NovoCure Ltd.
Information provided by (Responsible Party):
University of Aarhus ( Aarhus University Hospital )

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.


Condition or disease Intervention/treatment Phase
Glioblastoma Device: Optune Procedure: Craniectomy Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhancing Optune Therapy of Recurrent Glioblastoma Multiforme Using Targeted Surgical Skull Remodeling
Study Start Date : October 2016
Estimated Primary Completion Date : October 2019

Resource links provided by the National Library of Medicine


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:
  • NovoTTF-100A
  • Tumor treating fields
  • TTFields

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.




Primary Outcome Measures :
  1. Frequency of serious adverse events [ Time Frame: Through study completion, an average of 18 months. ]
    Based on CTCAE.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Through study completion, an average of 18 months. ]
  2. Progression free survival [ Time Frame: Through study completion, an average of 18 months. ]
  3. Progression free survival at six months [ Time Frame: Through study completion, an average of 18 months. ]
  4. % 1-year survival [ Time Frame: Through study completion, an average of 18 months. ]
  5. 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

  6. 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

  7. 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. ]
  8. 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. ]


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

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02893137


Contacts
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Contact: Anders R Korshoej, MD andekors@rm.dk

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus C, Aarhus, Denmark, 8000
Contact: Anders R Korshoej, MD       andekors@rm.dk   
Sub-Investigator: Gorm B von Oettingen, MD, PhD         
Sub-Investigator: Jens C Sørensen, Professor         
Sub-Investigator: Slavka Lucakova, MD, PhD         
Sponsors and Collaborators
Aarhus University Hospital
NovoCure Ltd.
Investigators
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Principal Investigator: Anders R Korshoej, MD Aarhus University Hospital

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Responsible Party: Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02893137     History of Changes
Other Study ID Numbers: 54762
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: August 2016
Keywords provided by University of Aarhus ( Aarhus University Hospital ):
Tumour treating fields
Optune
Craniectomy
TTFields
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue