Preoperative Preradiotherapy TTFields
ConditionGlioblastoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35+
SponsorThe Christie NHS Foundation Trust
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- TTFields
Treatment groups
42 Participants
are divided into 2 treatment groupsSponsors and collaborators
The Christie NHS Foundation Trust
Lead sponsor
University of Manchester
Collaborator
Northern Care Alliance NHS Foundation Trust
Collaborator
NovoCure Ltd.
Collaborator
Source ClinicalTrials.gov