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

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ClinicalTrials.gov Identifier: NCT04671459
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : January 26, 2021
Sponsor:
Collaborator:
NovoCure GmbH
Information provided by (Responsible Party):
Maciej Harat, Prof. Franciszek Lukaszczyk Memorial Oncology Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Recurrent Glioblastoma Combination Product: TTFields and SRS Phase 2

Detailed Description:

Almost all GBM patients experience recurrent disease. Stereotactic radiosurgery (SRS),at recurrence, has limitations due to the invasive nature of glioblastoma. TTFields may decrease the tumor aggressiveness outside the target area potentially by multiple pathways, including immunogenic cell death and DNA repair inhibition sensitizing to radiation. We hypothesize that combined SRS and TTFields will be complementary, improving outcomes with minimal toxicity.

In this open-label, phase II trial 40 participants with recurrence will be treated with SRS and TTFields, starting in 2020. Recurrence will be defined on FET-PET or MRI using RANO criteria.

All patients will begin treatment within 14 days from baseline imaging evaluation and at maximum 42 days from screening.

The attempt to obtain the Methyl-guanine methyl-transferase (MGMT) gene promoter methylation and IDH1 and IDH2 mutation from primary tumor are made during the study whenever not defined before entering to the study.

TTFields treatment will be initiated as in clinical routine at patients home. Admission to hospital will not be necessary.

SRS must be delivered within 7 days of TTFields start. A 5-day SRS regimen is allowed. TTFields should be interrupted only during SRS. The sample size of the study was calculated for the comparison of survival against a historical control.Overall survival will be stratified by volume, PET-based treatment, SVZ invasion, MGMT methylation status, time to first progression, and TTFields compliance.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Tumor Treating Fields (TTFields) Concomitant With Radiosurgery for the Treatment of Recurrent, Bevacizumab-naïve Glioblastoma
Actual Study Start Date : December 26, 2020
Estimated Primary Completion Date : December 9, 2022
Estimated Study Completion Date : December 9, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TTFields and SRS based on MRI or FET-PET
All subjects will receive TTFields and radiosurgery plus/minus FET PET imaging to define tumor volume.
 Combination Product: TTFields and SRS
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.
Other Name: Optune, Stereotactic Radiosurgery


Outcome Measures
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Primary Outcome Measures :
  1. 1-year survival rate [ Time Frame: 12 Months ]
    Survival will be measured from date of enrollment until date of death


Secondary Outcome Measures :
  1. Radiation necrosis range [ Time Frame: 12 months ]
    The percentage of patients who had radiation necrosis

  2. Progression free survival (PFS) [ Time Frame: 12 moths ]
    PFS will be measured from the date of enrollment to date of progression (in months) based on RANO citeria.

  3. Steroid needs until treatment failure [ Time Frame: 12 months ]
    The analysis will be performed based on the steroid doses reported in time of enrollment to date of progression or one year after

  4. Patterns of failure [ Time Frame: 12 months ]
    The analysis will be performed based on location of failure in relation to target volume

  5. Objective response rates [ Time Frame: 12 months ]
    The percentage of patients who had either complete response or partial response per RANO criteria following enrollment


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient's written informed consent (IC) obtained at the latest the day after planning MRI;
  2. Legal capacity: patient can understand the nature, significance, and consequences of the study;
  3. Age ≥18 years (no upper age limit);
  4. Karnofsky Performance Score (KPS) ≥ 70;
  5. Recurrence of GBM (WHO grade IV) based on RANO criteria or GBM after subtotal resection of recurrence with macroscopic residual tumor;
  6. Histological confirmation of GBM at initial or secondary diagnosis;
  7. Previous radiotherapy of glioma with a total dose of 59.4 - 60 Gy (single dose 1.8 - 2.0 Gy) and chemotherapy with temozolomide;
  8. At least 6 months between the end of the first course of radiotherapy and radiosurgery;
  9. 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);
  10. Start of TTFields before radiosurgery;
  11. Disease free from other cancers for ≥ 5 years;
  12. 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);

Exclusion Criteria:

  1. Recent (≤ 4 weeks before IC) histological result showing no tumor recurrence;
  2. Previous treatment of GBM with bevacizumab;
  3. Chemotherapy or molecular targeted therapies planned before diagnosis of further tumor progression after study intervention
  4. 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;
  5. Pregnancy, nursing, or patient not willing to prevent a pregnancy during treatment;
  6. Known or persistent abuse of medication, drugs or alcohol;
  7. Known allergy against the MRI contrast agent gadolinium or the PET tracer 18F-FET or against any of the components;
  8. Evidence of increased intracranial pressure (midline shift >5 mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness);
  9. Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
  10. Gross total resection of recurrence confirmed with postoperative MRI and negative FET-PET result
  11. Other malignancies ,except for non-melanomatous skin cancers, or carcinoma in-situ of uterus, cervix or bladder
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04671459


Contacts
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Contact: Maciej Harat, MD PhD + 48 787 370 610 gabinet@onkologharat.pl

Locations
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Poland
The Franciszek Lukaszczyk Oncology Center Recruiting
Bydgoszcz, Poland
Contact: Maciej Harat    + 48 787 370 610    haratm@co.bydgoszcz.pl   
Sponsors and Collaborators
Prof. Franciszek Lukaszczyk Memorial Oncology Center
NovoCure GmbH
Investigators
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Principal Investigator: Maciej Harat, MD PhD Prof. Franciszek Lukaszczyk Memorial Oncology Center
More Information
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Responsible Party: Maciej Harat, dr hab. n. med. Maciej Harat prof. UMK, Prof. Franciszek Lukaszczyk Memorial Oncology Center
ClinicalTrials.gov Identifier: NCT04671459    
Other Study ID Numbers: KB 2020
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD and all supporting data will be available upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Maciej Harat, Prof. Franciszek Lukaszczyk Memorial Oncology Center:
Glioblastoma
SRS
GBM
recurrent GBM
recurrence
stereotactic radiosurgery
 Radiosurgery
FET-PET
18F-fluoro-etyl-thyrosine
TTFields
Optune
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue