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Glioblastoma MultiformePhase 2TaRRGETNCT04671459

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

A Phase 2 study testing TTFields and SRS in people with Glioblastoma Multiforme and Recurrent Glioblastoma, run by Prof. Franciszek Lukaszczyk Memorial Oncology Center at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TTFields and SRS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePoland
Study dates
26 Dec 2020to 9 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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);

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • The Franciszek Lukaszczyk Oncology Center

    Bydgoszcz

Other trials in Poland

About this study

Official title: A Phase II Trial of Tumor Treating Fields (TTFields) Concomitant With Radiosurgery for the Treatment of Recurrent, Bevacizumab-naïve Glioblastoma

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.

Read the 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.

Being tested
TTFields and SRS
Keywords
Glioblastoma, SRS, GBM, recurrent GBM, recurrence, stereotactic radiosurgery, Radiosurgery, FET-PET, 18F-fluoro-etyl-thyrosine, TTFields, Optune
Medical subject headings
Glioblastoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TTFields and SRSCombination product

    Also called Optune, Stereotactic Radiosurgery

    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.

Study groups in NCT04671459
Study groupRoleWhat they receive
TTFields and SRS based on MRI or FET-PETExperimentalAll subjects will receive TTFields and radiosurgery plus/minus FET PET imaging to define tumor volume.
Receives: Combination Product: TTFields and SRS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1-year survival rate

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

    Measured: 12 Months

Secondary outcomes (5)

  1. Radiation necrosis range

    The percentage of patients who had radiation necrosis

    Measured: 12 months

  2. Progression free survival (PFS)

    PFS will be measured from the date of enrollment to date of progression (in months) based on RANO citeria.

    Measured: 12 moths

  3. Steroid needs until treatment failure

    The analysis will be performed based on the steroid doses reported in time of enrollment to date of progression or one year after

    Measured: 12 months

  4. Patterns of failure

    The analysis will be performed based on location of failure in relation to target volume

    Measured: 12 months

  5. Objective response rates

    The percentage of patients who had either complete response or partial response per RANO criteria following enrollment

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start26 Dec 2020
  3. Primary completion20 Jul 2023 (estimated)
  4. Study completion9 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04671459
Sponsor's protocol ID
KB 2020
Acronym
TaRRGET
Status last verified
Jun 2023
First submitted
5 Dec 2020
Last updated
28 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD and all supporting data will be available upon request.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TTFields and SRS in people with Glioblastoma Multiforme and Recurrent Glioblastoma, run by Prof. Franciszek Lukaszczyk Memorial Oncology Center at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year survival rate (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04671459.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.

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