TTFields and Radiosurgery of Recurrent Glioblastoma +/- 18F-Fluoro-Ethyl-Thyrosine

NCT04671459 | Unknown Phase 2 DMC

• 1 other identifier: KB 2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

All patients will receive TTFields therapy and additionally Stereotactic Radiosurgery . Radiosurgery will be based on MRI and FET-PET or MRI alone. Addition of FET-PET will be preferred option.

Conditions

Glioblastoma Multiforme; Recurrent Glioblastoma

Keywords

Glioblastoma; SRS; GBM; recurrent GBM; recurrence; stereotactic radiosurgery; Radiosurgery; FET-PET; 18F-fluoro-etyl-thyrosine; TTFields; Optune

Outcome Measures

Primary Outcomes (1)

• 1-year survival rate

  Survival will be measured from date of enrollment until date of death

  12 Months

Secondary Outcomes (5)

• Radiation necrosis range

  12 months

• Progression free survival (PFS)

  12 moths

• Steroid needs until treatment failure

  12 months

• Patterns of failure

  12 months

• Objective response rates

  12 months

Study Arms (1)

TTFields and SRS based on MRI or FET-PET

EXPERIMENTAL

All subjects will receive TTFields and radiosurgery plus/minus FET PET imaging to define tumor volume.

Combination Product: TTFields and SRS

Interventions

TTFields and SRS COMBINATION_PRODUCT

SRS procedure will be delivered within 7 days after start of TTFields therapy . A 5-day SRS regimen is allowed. TTFields should be interrupted in time of SRS and start immediately after.

Also known as: Optune, Stereotactic Radiosurgery

TTFields and SRS based on MRI or FET-PET

Eligibility Criteria

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

You may qualify if:

• Patient's written informed consent (IC) obtained at the latest the day after planning MRI;
• Legal capacity: patient can understand the nature, significance, and consequences of the study;
• Age ≥18 years (no upper age limit);
• Karnofsky Performance Score (KPS) ≥ 70;
• Recurrence of GBM (WHO grade IV) based on RANO criteria or GBM after subtotal resection of recurrence with macroscopic residual tumor;
• Histological confirmation of GBM at initial or secondary diagnosis;
• Previous radiotherapy of glioma with a total dose of 59.4 - 60 Gy (single dose 1.8 - 2.0 Gy) and chemotherapy with temozolomide;
• At least 6 months between the end of the first course of radiotherapy and radiosurgery;
• Recurrent tumor visible on FET-PET and/or T1Gd-MRI, with the maximum diameter up to 5 cm by either technique (in case of multifocal tumors, the sum of all diameters must be 5 cm on FET-PET and T1Gd-MRI);
• Start of TTFields before radiosurgery;
• Disease free from other cancers for ≥ 5 years;
• Adequate haematologic, renal and hepatic function (absolute neutrophil count ⩾1000/mm3; haemoglobin ⩾100 g/L platelet count, ⩾100,000/mm3; serum creatinine level ⩽1.7 mg/dL (\<150 μmol/L); total serum bilirubin level ⩽ the upper limit of normal and liver-function values, \<3 times the upper limit of normal);

You may not qualify if:

• Recent (≤ 4 weeks before IC) histological result showing no tumor recurrence;
• Previous treatment of GBM with bevacizumab;
• Chemotherapy or molecular targeted therapies planned before diagnosis of further tumor progression after study intervention
• Simultaneous participation in other interventional trials which could interfere with this trial and/or participation in a clinical trial within the last thirty days before the start of this study and/or previous participation (randomization) in this study;
• Pregnancy, nursing, or patient not willing to prevent a pregnancy during treatment;
• Known or persistent abuse of medication, drugs or alcohol;
• Known allergy against the MRI contrast agent gadolinium or the PET tracer 18F-FET or against any of the components;
• Evidence of increased intracranial pressure (midline shift \>5 mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness);
• Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
• Gross total resection of recurrence confirmed with postoperative MRI and negative FET-PET result
• Other malignancies ,except for non-melanomatous skin cancers, or carcinoma in-situ of uterus, cervix or bladder

Sponsors & Collaborators

• Prof. Franciszek Lukaszczyk Memorial Oncology Center: lead
• NovoCure GmbH: collaborator

Study Sites (1)

The Franciszek Lukaszczyk Oncology Center

Bydgoszcz, Poland

Location

MeSH Terms

Conditions

Glioblastoma; Recurrence

Interventions

Spermine Synthase; Radiosurgery

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Maciej Harat, MD PhD

  Prof. Franciszek Lukaszczyk Memorial Oncology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr hab. n. med. Maciej Harat prof. UMK

Model Details: This is an open-label, phase II trial enrolling participants with recurrences or progressive tumor, who will be treated with radiosurgery and TTFields. The investigators will attempt to enroll the maximum number of patients and expect to enroll 40 subjects. All subjects will receive TTFields and radiosurgery plus/minus FET PET imaging to define tumor volume.

Study Record Dates

• First Submitted: December 5, 2020
• First Posted: December 17, 2020
• Study Start: December 26, 2020
• Primary Completion: July 20, 2023
• Study Completion: December 9, 2024
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)