NCT04223999: OptimalTTF-2

Improving Tumor Treating Fields Treatment for Brain Cancer Patients With Skullremodeling Surgery (Neurosurgery)

Status unknown Phase 2 Last updated 6 June 2023

What this trial tests

Phase 2 trial testing Skullremodeling surgery in Recurrent Glioblastoma in 70 participants. Status unknown.

Timeline

1 October 2020

Primary endpoint
1 March 2024

1 March 2026

Quick facts

Lead sponsor	Anders Rosendal Korshøj
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	70
Start date	1 October 2020
Primary completion	1 March 2024
Estimated completion	1 March 2026
Sites	1 location across Denmark

Drugs / interventions tested

• Skullremodeling surgery
• Control

Conditions studied

• Recurrent Glioblastoma — all drugs for Recurrent Glioblastoma →

Sponsor

Anders Rosendal Korshøj

Who can join

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

Sponsor's own description

The aim of this trial is to test a new potential treatment, skullremodeling surgery (SR-surgery) combined with tumor treating fields (TTFields), for patients with first recurrence of malignant brain tumor (first recurrence of glioblastoma). Glioblastoma is one of the most malignant cancers.

TTFields is a new treatment for brain cancer (glioblastoma), which is used in additional to surgery (removal of the tumor), chemotherapy and radiation. TTFields work by sending alternating current to the tumor. The current disrupts cell division and thus prevents cancer growths. Electrodes are placed on the scalp and the current is delivered via a small portable battery (1kg). Treatment duration is 18 hours during the day, where the patient can do normal daily activities. The average life expectancy of a newly diagnosed brain cancer patient (glioblastoma) is increased from 15 months to 21 months by adding TTFields.

SR-surgery is a minor and safe procedure, that involves creating small burrholes in the skull over the tumor location. The burrholes are approximately 15 mm in diameter. The burrholes increase the electric current in the tumor by funneling the electricity trough the path of least resistance, since bone hinders the electricity.

The theory is that combining TTFields with SR-surgery we can increase the effect of TTFields and in return increase overall survival for brain cancer patients.

The investigators have recently finished a phase 1 clinical trial, with 15 trial participants, testing the safety and efficacy of our combined treatment. The investigators concluded that TTFields and SR-surgery combined is safe and showed promising results by increasing overall survival with the trial participants.

Therefor we wish to proceed with a phase 2 trial.

Method The investigators aim to include 70 patients with first recurrence of glioblastoma (brain cancer). Each patient will be randomized to one of two treatment arms. Both treatment arms will receive the best current brain tumor treatment. In addition, one arm receives TTF and the other arm TTFields and SR-surgery.

All patients are expected to receive better treatment than current best practice, since TTFields is not standard treatment in Denmark.

The primary aim of the trial is to assess the 12-month overall survival in both groups. The theory is that more trial participants will be alive after 12 months in the group that receives both TTF and SR-surgery.

The trial duration is 36 months with an average expected follow-up of 18 months.

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. 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
3. Recent advances in Tumor Treating Fields (TTFields) therapy for glioblastoma.
   Khagi S, Kotecha R, Gatson NTN, Jeyapalan S, et al · · 2025 · cited 20× · PMID 39401002 · DOI 10.1093/oncolo/oyae227
4. 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
5. 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
6. Tumor treating fields for the treatment of glioblastoma: Current understanding and future perspectives.
   Colamaria A, Leone A, Fochi NP, Di Napoli V, et al · · 2023 · cited 9× · PMID 38053701 · DOI 10.25259/sni_674_2023
7. Meta-Analysis of Modulated Electro-Hyperthermia and Tumor Treating Fields in the Treatment of Glioblastomas.
   Szasz AM, Arrojo Alvarez EE, Fiorentini G, Herold M, et al · · 2023 · cited 9× · PMID 36765840 · DOI 10.3390/cancers15030880
8. Therapeutic potential of tumor treating fields for malignant brain tumors.
   Zhou Y, Xing X, Zhou J, Jiang H, et al · · 2023 · cited 8× · PMID 36987739 · DOI 10.1002/cnr2.1813