Combining skull remodeling surgery with tumor treating fields for brain cancer
Enhancing Tumor Treating Fields for Recurrent Glioblastoma With Targeted and Individualised Skullremodeling Surgery: A Multi-center Randomized Phase 2 Trial
This study is testing if combining a minor skull surgery with a new electric field treatment can help people with recurring brain cancer live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Drugs / interventions | chemotherapy, radiation, bevacizumab |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT04223999 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of skull remodeling surgery (SR-surgery) in conjunction with tumor treating fields (TTFields) for patients experiencing the first recurrence of glioblastoma. TTFields is a novel treatment that uses low-intensity alternating electric fields to disrupt cancer cell division, while SR-surgery is a minor procedure that creates burrholes in the skull to facilitate treatment. Participants will receive TTFields therapy for 18 hours daily, allowing them to maintain normal activities. The study seeks to improve survival outcomes for patients with recurrent glioblastoma by combining these two approaches.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with progressive glioblastoma and specific tumor characteristics that allow for surgical intervention.
Not a fit: Patients with extensive disease not amenable to surgery or those with a life expectancy of less than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly extend survival and improve quality of life for patients with recurrent glioblastoma.
How similar studies have performed: Previous studies have shown that TTFields can provide significant survival benefits for glioblastoma patients, indicating a promising approach in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age 18 years or older 2. progressive GBM based on the RANO criteria and whole brain MRI according to the consensus recommendations for a standardized brain tumor imaging protocol in clinical trials , not older than 4 weeks from the assessment 3. estimated survival≥ 3 months 4. supratentorial tumor location 5. focal disease in the vicinity of the previously known tumor or resection cavity, 6. KPS≥70 7. ability to comply with TTFields treatment 8. eligibility for diagnostic or therapeutic neurosurgery and subsequent best practice oncological therapy, 9. tumor characteristics indicating significant expected benefit from feasible craniectomy or SR-surgery combined with TTFields i.e. (a) focal tumor and (b) most superficial border of tumor or resection cavity closer than 2 cm from brain surface 10. use of validated anticonception for fertile female participants in concordance with guidelines provided by the danish health and medicines authority, 11. signed written consent form Exclusion Criteria: 1. pregnancy or nursing (fertile female participants will be required to take a validated pregnancy test for evaluation of pregnancy) 2. infra-tentorial tumor 3. implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmia 4. uncontrollable symptomatic epilepsy refractory to standard medication 5. contraindications for skullremodeling surgery, e.g.bleeding diathesis or severe infection 6. significant co-morbidities, i.e. (a)significant liver function impairment (alt \>210 u/l for men and \> 135 u/l for women or total bilirubin \>25umol/l), (b)significant renal impairment (serum creatinine \> 1.7 mg/dl= 150 umol/l), (c)coagulopathy (inr\> 1.8 or aptt \> 57s), (d) thrombocytopenia (platelet count \< 100 x 103/μl =100 x 109/l), (e) neutropenia (anc\< 1.5 x 103/μl =1.5 x 109/l), (f) anemia ( hb \< 10 g/l= 6.0 mmol/l) 7. severe cognitive impairment 8. active participation in another therapeutic interventional clinical trial
Where this trial is running
Aarhus
- Nikola Mikic — Aarhus, Denmark (Recruiting)
Study contacts
- Principal investigator: Anders R Korshøj, MD, PhD — Aarhus University Hospital
- Study coordinator: Nikola Mikic, MD
- Email: nikolanm@gmail.com
- Phone: +4593972105
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.