Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: OptuneExperimental treatment 1 intervention
Group B: Non-Experimental ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
18 months
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 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 radiotherapy (RT) possibly related to the TTFields treatment (later than 6 weeks postoperative)

Time frame
18 months

Secondary outcomes

1

Concordance between MRI based diagnosis of glioblastoma and definitive histological diagnosis

Evaluate the use of MRI to select glioblastoma patients for PORTRAIT without pathological confirmation.

Time frame
18 months
2

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

Evaluate the effect of TTFields on REP - tumour growth between surgery and postoperative chemoradiotherapy, in patients with a new diagnosis of glioblastoma. A lower value represents a better outcome.

Time frame
18 months
3

Registration of postoperative surgical complications

Postoperative surgical complications (e.g. haemorrhage, wound infection, delayed wound healing, seizures). Lower registrations represents a better outcome.

Time frame
18 months
4

Registration of radiotherapy related complications

Radiotherapy related complications (e.g. radiation necrosis). Lower registrations represents a better outcome.

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Christie NHS Foundation Trust

Lead sponsor

University of Manchester

Collaborator

Northern Care Alliance NHS Foundation Trust

Collaborator

NovoCure Ltd.

Collaborator

Source ClinicalTrials.gov
Apply now