Preoperative Preradiotherapy TTFields

Summary

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.

Interventions

• TTFields · DEVICE

  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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* Patient is aged \>35 years (age range of more likely to suffer from an IDHwt World Health Organisation (WHO) grade 4 astrocytoma)\*
* Patient is male or female.
* Patient has a new radiological diagnosis of glioblastoma.
* Patient has a performance status judged by WHO, Eastern Cooperative Oncology Group (ECOG) score = 0-1.
* 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 Optune based on available clinical information and imaging.
* PI has confirmed 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).
* There is intention to treat the patient with surgical resection and postoperative adjuvant therapy as per current standard of care (40Gy/15 fr or 60Gy/30fr).
* Patient has adequate haematological and biochemical parameters for surgery and contrast agent administration (full blood count and coagulation profile deemed acceptable by clinical team, eGFR \>30ml/min).
* Patient has mental capacity to consent for treatment.
* Patient is able and willing to give informed consent

Criteria specific to the experimental arm:

* Patient is able and willing to comply with study protocol requirements to continuously shave their head
* Patient is able and willing to comply with study protocol requirements to wear Optune equipment for the required duration.

Exclusion Criteria:

* Patients with uncontrolled seizures.
* Patients are due to undergo a planned biopsy procedure only.
* Patients have a suspicion of other tumour on CT body scan or known malignancy except non-melanoma skin cancer, completely resected or prostate cancer (with Prostate Specific Antigen of less than or equal to 0.1 ng/ml) within the past three years.
* Patients have contraindications to contrast-enhanced MRI scanning (e.g. claustrophobia, gadolinium allergy).

Sites (1)

• The Christie NHS Foundation Trust, Manchester, United Kingdom · RECRUITING