Status:
NOT_YET_RECRUITING
Preoperative Preradiotherapy TTFields
Lead Sponsor:
The Christie NHS Foundation Trust
Collaborating Sponsors:
University of Manchester
Northern Care Alliance NHS Foundation Trust
Conditions:
Glioblastoma
Eligibility:
All Genders
35+ years
Phase:
NA
Brief 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...
Detailed Description
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 chemot...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06136611
Start Date
July 31 2024
End Date
December 1 2025
Last Update
June 24 2024
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