PORTRAIT: Preoperative Preradiotherapy TTFields
Research type
Research Study
Full title
PORTRAIT: Preoperative Preradiotherapy TTFields
IRAS ID
319109
Contact name
Gerben Borst
Contact email
Sponsor organisation
The Christie NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 28 days
Research summary
Glioblastoma is the most common primary malignant brain tumour in adults. Its outcomes are poor due to local disease progression in most patients. Current treatment includes surgery followed by chemotherapy and radiotherapy 4-6 weeks after surgery. In this time interval, some tumour cells do not receive any treatment. Furthermore, studies show that around half of all glioblastoma patients experience rapid early progression (REP) i.e. growth of the tumour in the time interval between surgery and postoperative chemotherapy/radiotherapy. REP is associated with a shorter survival and there are currently no effective treatments or preventative measures to address it.
Tumour Treating Fields (TTFields), also known as Optune, is the only treatment modality that contributed to the overall survival in the last decade as shown in one Randomized Controlled Trial. We hypothesize that earlier treatment using the Optune device before the surgery and between the surgery and postoperative radiotherapy can prevent REP and improve patient outcome. In this phase 1 trial, PORTRAIT (PreOpeRaTive pRerAdIotherapy Ttfields), we will test the safety and feasibility of Optune treatment before surgery and before post-operative radiotherapy in a maximum of 14 patients. Participants will be required to undergo additional MRI sequencing scans and provide blood, tear fluid and tissue samples over a maximum of 6 months.
To maximise PORTRAIT's translational and clinically relevant components, a non-experimental arm (Non-EA) of 28 patients will allow comparisons of data collected from PORTRAIT patients with comparable Standard of Care (SoC) treated patients from the same time frame.
Participants will be invited to the research study if they are over the age of 35 and have a new radiological diagnosis of glioblastoma. All recruitment and treatment will be conducted at the Christie NHS Foundation Trust and Northern Care Alliance NHS Foundation Trust.
The study is funded by a research grant from Novocure.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
23/EE/0279
Date of REC Opinion
30 Jan 2024
REC opinion
Further Information Favourable Opinion