Improving Tumor Treating Fields Treatment for Brain Cancer Patients With Skullremodeling Surgery (Neurosurgery) (OptimalTTF-2)
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|ClinicalTrials.gov Identifier: NCT04223999|
Recruitment Status : Not yet recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Glioblastoma||Procedure: Skullremodeling surgery Other: Control||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be randomized 1:1 to one of two study arms to receive either, 1) skullremodeling-surgery, TTFields and best practice medical oncological therapy (interventional arm), or 2) TTFields and best practice medical oncological therapy alone (control arm).|
|Masking:||Single (Outcomes Assessor)|
Skullremodeling surgery prevents the participant, careprovider and investigator to be blinded to the randomization.
The outcome assessors (statisticians) will be blinded when analysing the data.
|Official Title:||Enhancing Tumor Treating Fields for Recurrent Glioblastoma With Targeted and Individualised Skullremodeling Surgery: A Multi-center Randomized Phase 2 Trial|
|Estimated Study Start Date :||March 1, 2020|
|Estimated Primary Completion Date :||March 1, 2023|
|Estimated Study Completion Date :||March 1, 2024|
In this arm, trial participants receive the intervention that is being tested, skullremodeling surgery. This is in combination with tumor treating fields and best practice medical treatment.
Procedure: Skullremodeling surgery
Strategically placed cranial burrholes in order to improve the TTField "dose" focally in the tumor.
Other Name: SR-surgery
Active Comparator: Control
In this arm, the trial participant receives tumor treating fields and best practice medical treatment.
This serves as an active comparative control arm to the intervention.
Tumor treating fields combined with best medical treatment.
- OS12 [ Time Frame: 12 months from the time of randomization. ]12-month overall survival.
- Median OS [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 month. ]Median overall survival.
- Median PFS [ Time Frame: From date of randomization until the date of first documented progression, assessed up to 36 months. ]Median progression-free survival.
- OS24 [ Time Frame: 24 months from the time of randomization. ]24-month overall survival
- OS36 [ Time Frame: 36 months from the time of randomization. ]36-month overall survival
- PFS6 [ Time Frame: 6 months from the time of randomization ]6-month progression-free survival
- ORR [ Time Frame: Assessed every 3. month, up to 36 months or death, whichever comes first. ]Overall objective response rate assessed by modified RANO criteria
- Standardised and verified quality of life assessment questionnaires (QLQ-C30 and QLQ-BN20) for cancer and brain tumor patients. [ Time Frame: Assessed at inclusion and every 3. month, assessed up to 36 months or death, whichever comes first. ]Standardised and verified questions related to quality of life to cancer and brain tumor patients. Quality of life is rated by the patients own thoughts about the current situation and future and also the presence or absence of the most common symptoms in cancer and brain tumors. Rated from a scale 1-4 (none to a lot) and 1-7 scale (very poor to very good).
- Steroid dose [ Time Frame: From the time of inclusion and every 3. month, assessed up to 36 months or death, whichever comes first. ]Cumulative corticosteroid usage
- KPS [ Time Frame: From time of inclusion and every 3. month, assessed up to 36 months or death, whichever comes first. ]Assessing KPS.
- AE [ Time Frame: From time of inclusion and every 3. month, assessed up to 36 months or death, whichever comes first. ]Adverse events / Safety. All adverse events observed by personnel or reported by trial participant.
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): NCT04223999
|Contact: Nikola Mikic, MDfirstname.lastname@example.org|
|Contact: Anders R Korshøj, MD, PhDemail@example.com|
|Aarhus University Hospital|
|Aarhus, Denmark, 8200|
|Principal Investigator:||Anders R Korshøj, MD, PhD||Aarhus University Hospital|