NCT02893137

Enhancing Optune Therapy With Targeted Craniectomy

Completed Phase 1 Last updated 27 November 2019

What this trial tests

Phase 1 trial testing Optune in Glioblastoma in 15 participants. Completed in 31 May 2019.

Timeline

1 October 2016

Primary endpoint
31 May 2019

31 May 2019

Quick facts

Lead sponsor	Aarhus University Hospital
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	1 October 2016
Primary completion	31 May 2019
Estimated completion	31 May 2019
Sites	1 location across Denmark

Drugs / interventions tested

• Optune
• Craniectomy

Conditions studied

• Glioblastoma — all drugs for Glioblastoma →

Sponsor

Aarhus University Hospital

Who can join

18 and older, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tumor-Treating Fields in Glioblastomas: Past, Present, and Future.
   Guo X, Yang X, Wu J, Yang H, et al · · 2022 · cited 39× · PMID 35954334 · DOI 10.3390/cancers14153669
2. Impact of tumor position, conductivity distribution and tissue homogeneity on the distribution of tumor treating fields in a human brain: A computer modeling study.
   Korshoej AR, Hansen FL, Thielscher A, von Oettingen GB, et al · · 2017 · cited 38× · PMID 28604803 · DOI 10.1371/journal.pone.0179214
3. Importance of electrode position for the distribution of tumor treating fields (TTFields) in a human brain. Identification of effective layouts through systematic analysis of array positions for multiple tumor locations.
   Korshoej AR, Hansen FL, Mikic N, von Oettingen G, et al · · 2018 · cited 37× · PMID 30133493 · DOI 10.1371/journal.pone.0201957
4. Enhancing Predicted Efficacy of Tumor Treating Fields Therapy of Glioblastoma Using Targeted Surgical Craniectomy: A Computer Modeling Study.
   Korshoej AR, Saturnino GB, Rasmussen LK, von Oettingen G, et al · · 2016 · cited 33× · PMID 27695068 · DOI 10.1371/journal.pone.0164051
5. OptimalTTF-1: Enhancing tumor treating fields therapy with skull remodeling surgery. A clinical phase I trial in adult recurrent glioblastoma.
   Korshoej AR, Lukacova S, Lassen-Ramshad Y, Rahbek C, et al · · 2020 · cited 27× · PMID 33215088 · DOI 10.1093/noajnl/vdaa121
6. Study protocol for OptimalTTF-2: enhancing Tumor Treating Fields with skull remodeling surgery for first recurrence glioblastoma: a phase 2, multi-center, randomized, prospective, interventional trial.
   Mikic N, Poulsen FR, Kristoffersen KB, Laursen RJ, et al · · 2021 · cited 16× · PMID 34503460 · DOI 10.1186/s12885-021-08709-4
7. Tumor-treating fields (TTFields)-based cocktail therapy: a novel blueprint for glioblastoma treatment.
   Wang M, Zhang C, Wang X, Yu H, et al · · 2021 · cited 15× · PMID 33948346
8. Tumor treating fields in the management of Glioblastoma: opportunities for advanced imaging.
   Soni VS, Yanagihara TK. · · 2019 · cited 11× · PMID 31783910 · DOI 10.1186/s40644-019-0259-8