Preoperative Preradiotherapy TTFields

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Preoperative Preradiotherapy TTFields

Study Purpose

PreOperative PreRAdIotherapy Tumour Treating Fields (PORTRAIT) is a Phase I study that will test the safety and feasibility of Optune administered preoperatively and preradiotherapy in patients with a new radiological diagnosis of glioblastoma (GBM). Participants will be required to undergo additional MRI sequencing scans and provide blood, tear fluid and tissue samples over a maximum of 6 months. After the study patients will follow their standard treatment pathway.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	35 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age ≥ 35 years (age range of likely to suffer from an IDHwt WHO grade 4 astrocytoma)* - Male or female.

- New radiological diagnosis of glioblastoma.

- Performance status judged by World Health Organisation, Eastern Cooperative Oncology Group [ECOG] score = 0-1.

- The patient has been reviewed by Neuro-oncology multidisciplinary team (MDT - neurosurgeon, clinical oncologist, radiologist and pathologist); MDT consensus that offering study entry is clinically appropriate and safe i.e. patient unlikely to come to harm (e.g. hydrocephalus) from delayed surgery and pre-operative TTFields based on available clinical information and imaging.

- Confirmation at the first clinic visit that study entry is clinically appropriate and safe (e.g. lack of severe and debilitating symptoms of raised intracranial pressure).

- Intention to treat with surgical resection and postoperative adjuvant therapy as per current standard of care (40Gy/15 fr or 60Gy/30fr).

- Adequate hematological and biochemical parameters for surgery and contrast agent administration (full blood count and coagulation profile deemed acceptable by clinical team, eGFR >30ml/min).

- Mental capacity to consent for treatment.

- Able and willing to give informed consent.

- Able and willing to comply with study protocol requirements to shave head and wear TTFields equipment.

Exclusion Criteria:

- Planned biopsy procedure only.

- Suspicion of other tumour on CT body scan or known malignancy except non-melanoma skin cancer, completely resected cerCTcCT or prostate cancer (with Prostate Specific Antigen of less than or equal to 0.1 ng/ml) within the past three years.

- Contraindications to contrast-enhanced MRI scanning (e.g. claustrophobia, gadolinium allergy).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06136611
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The Christie NHS Foundation Trust
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Additional Details

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. Optune is a wearable, portable, FDA-approved glioblastoma (GBM) treatment. It works by creating Tumor Treating Fields (TTFields), which are electric fields that slow down or stop GBM cancer cell division. TTFields is the only treatment modality that contributed to the overall survival in the last decade as shown in one Randomized Controlled Trial. The investigators hypothesize that earlier treatment using Optune before the surgery and between the surgery and postoperative radiotherapy can prevent REP and improve patient outcomes. In this phase 1 trial, PORTRAIT (PreOpeRaTive pRerAdIotherapy Ttfields), the study will test the safety and feasibility of giving Optune 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.

Arms & Interventions

Arms

Experimental: Optune

Patients will apply TTFields (a treatment device referred to as Optune) before surgery and continue using this once the stitches are removed (approximately one to two weeks after surgery). Patients will wear the Optune application for 2 to 3 weeks before their standard-of-care (SoC) surgery and 3 to 4 weeks after the surgery (while awaiting their postoperative radiotherapy). Treatment with TTFields will be delivered through 4 transducer arrays with 9 insulated electrodes each placed on the shaved scalp and connected to a portable device set to generate 200-kHz electric fields within the brain.

No Intervention: Non-Experimental Arm

Patients will follow the routine care pathway for glioblastoma and timings of the following will be determined by the clinical team.

Interventions

Device: - TTFields

TTFields will be delivered through 4 transducer arrays with 9 insulated electrodes each placed on the shaved scalp and connected to a portable device set to generate 200-kHz electric fields within the brain.