Preoperative Preradiotherapy TTFields

NCT06136611 | Not Yet Recruiting DMC

• 2 other identifiers: CFTSp221319109
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Glioblastoma

Keywords

Neoadjuvant; Preoperative; Tumour Treating Fields

Outcome Measures

Primary Outcomes (2)

• To determine the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Pre-Operative and Pre-Radiotherapy TTFields additional to the standard treatment of care (SoC) including adjuvant TTFields.

  This endpoint will be tested by skin toxicity / wound complications. Toxicity is defined using CTCAE v5.0 and study related complications are defined as; * Skin toxicity grade 3 or higher * Wound closure or wound healing problems grade 2 or higher that are possibly related to TTFields treatment

  18 months

• To determine the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Pre-Operative and Pre-Radiotherapy TTFields additional to the standard treatment of care (SoC) including adjuvant TTFields.

  This endpoint will be tested by alterations to the original date of surgery and the start of the postoperative radiotherapy; Study related complications will be defined as; * Change of surgery date due to symptoms related to the tumour that are possibly related to the TTFields treatment * Delay of start of the postoperative RT possibly related to the TTFields treatment (later than 6 weeks postoperative)

  18 months

Secondary Outcomes (9)

• Concordance between MRI based diagnosis of glioblastoma and definitive histological diagnosis

  18 months

• REP: tumour volume difference between the post-operative MRI and pre-radiotherapy MRI.

  18 months

• Registration of postoperative surgical complications

  18 months

• Registration of radiotherapy related complications

  18 months

• Steroid dose after TTFields

  18 months

Study Arms (2)

Optune

EXPERIMENTAL

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.

Device: TTFields

Non-Experimental Arm

NO INTERVENTION

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

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.

Optune

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead
• University of Manchester: collaborator
• Northern Care Alliance NHS Foundation Trust: collaborator
• NovoCure Ltd.: collaborator

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Gerben R Borst, MD PhD

CONTACT

0161 446 3000; gerben.borst@nhs.net

Lauren Hewitt, MSc

CONTACT

0161 446 3000; lauren.hewitt@manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PORTRAIT is a cohort study including: 14 prospective patients for the experimental arm which assumes a TRUE toxicity rate of 20% (the study needs 13 patients and we allow 1 patient for replacement). This means that there is less than 10% chance that 4 or more patients will experience a toxicity defined as a complication. For the non-experimental arm, 28 prospective patients will be recruited.

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: November 18, 2023
• Study Start: July 31, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Anonymised data will be made freely available following any temporary data embargos put in place by the funder or from researchers rights to the exclusive use of data (e.g. 6 months).
• Access Criteria: Appropriate scientific justification, review by Principal Investigator and Trial Management Group, necessary legal contracts e.g. Data Access Agreements in place.