Clinical Trials Logo

Clinical Trial Summary

The present study proposes a new and potentially superior clinical approach to Optuneā„¢ 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.


Clinical Trial Description

n/a


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02893137
Study type Interventional
Source University of Aarhus
Contact Anders R Korshoej, MD
Email andekors@rm.dk
Status Recruiting
Phase Phase 1
Start date October 2016

See also
  Status Clinical Trial Phase
Recruiting NCT02768389 - Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma Early Phase 1
Completed NCT01250470 - Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma Phase 1
Recruiting NCT01454596 - CAR T Cell Receptor Immunotherapy Targeting EGFRvIII for Patients With Malignant Gliomas Expressing EGFRvIII Phase 1/Phase 2
Recruiting NCT01813877 - Response Monitoring Trial in Patients With Suspected Recurrence of Glioblastoma N/A
Recruiting NCT03278249 - Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma N/A
Recruiting NCT02709889 - Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors Phase 1/Phase 2
Enrolling by invitation NCT02905643 - Discerning Pseudoprogression vs True Tumor Growth in GBMs N/A
Withdrawn NCT02876003 - Efficacy and Safety of G-202 in PSMA-Positive Glioblastoma Phase 2
Active, not recruiting NCT02366728 - DC Migration Study for Newly-Diagnosed GBM Phase 2
Recruiting NCT01985087 - A Study Using Radiation Therapy and Temozolomide to Treat Glioblastoma in Patients Over 70 Phase 1/Phase 2
Withdrawn NCT01622764 - 89Zr-RO5323441 PET Imaging in Glioblastoma Phase 2
Recruiting NCT01765088 - A Phase III Trial on Adjuvant Temozolomide With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas Phase 3
Completed NCT01836536 - Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients N/A
Active, not recruiting NCT01339052 - Phase II Study of BKM120 for Subjects With Recurrent Glioblastoma Phase 2
Completed NCT01493219 - Biomarkers for Prognosis of Glioblastoma (GBM) N/A
Terminated NCT01227434 - A Study of PD 0332991 in Patients With Recurrent Rb Positive Glioblastoma Phase 2
Completed NCT01171469 - Vaccination With Dendritic Cells Loaded With Brain Tumor Stem Cells for Progressive Malignant Brain Tumor Phase 1
Completed NCT00960492 - Safety Study of XL184 (Cabozantinib) in Combination With Temozolomide and Radiation Therapy in the Initial Treatment of Adults With Glioblastoma Phase 1
Completed NCT00973557 - The Effect of Monoclonal Vascular Endothelial Growth Factor (VEGF) Antibody (Bevacizumab) on Pituitary Function N/A
Completed NCT00941460 - Comparison of Two Dosing Regimens of Temozolomide in Patients With Progressive or Recurrent Glioblastoma Phase 2