Preoperative Preradiotherapy TTFields

Launched by THE CHRISTIE NHS FOUNDATION TRUST · Nov 15, 2023

Keywords

ClinConnect Summary

The PORTRAIT trial is a research study aimed at exploring the safety and feasibility of a treatment called Optune for patients diagnosed with glioblastoma, a type of aggressive brain tumor. This study will look into how well Optune can be used before surgery and radiation therapy. Participants will be asked to undergo some additional MRI scans and provide samples of blood, tears, and tissue over a period of up to six months. After completing the study, patients will continue with their usual treatment plan.

To join this trial, participants must be over 35 years old and have a new diagnosis of glioblastoma. They should be in good overall health, as judged by their medical team, and should be able to provide informed consent. Participants will need to shave their heads and wear the Optune device as part of the trial. It’s important to note that this study is not yet recruiting, so patients and families should keep an eye out for updates if they’re interested.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient is aged \>35 years (age range of more likely to suffer from an IDHwt WHO grade 4 astrocytoma)\*
• • Patient is male or female.
• • Patient has a new radiological diagnosis of glioblastoma.
• • Patient has a performance status judged by World Health Organisation, 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).