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TTFields In GErmany in Routine Clinical Care (TIGER)

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ClinicalTrials.gov Identifier: NCT03258021
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd.

Brief Summary:
The purpose of this post-authorisation medical device study is to obtain real life data on the use of tumor-treating fields (TTFields) in patients with newly diagnosed GBM in routine clinical care in Germany. Patients with newly diagnosed GBM and clinical indication for TTFields treatment will be enrolled in the study after signing Informed consent to use their data and process it centrally for research purposes. The clinical indication for TTFields is one of the inclusion criteria and is defined prior to inclusion by the treating physician. The patient's decision regarding TTFields treatment is part of the observation and will be assessed within the baseline visit.

Condition or disease Intervention/treatment
Glioblastoma Device: TTFields

Detailed Description:

Glioblastoma (GBM) is the most common malignant primary tumor of the brain. The current standard of care for patients with newly diagnosed GBM consists of maximal surgical resection, approx. 60 Gy of radiotherapy together with chemotherapy using temozolomide (TMZ), followed by maintenance TMZ for 6 months. This treatment scheme was shown to extend median survival from 12.1 to 14.6 months compared to surgery and radiotherapy alone. This survival was essentially unchanged since 2005 despite numerous clinical Phase 3 trials conducted.

Although immense efforts were made over the years with different treatment strategies, the survival of patients with newly diagnosed GBM remained very poor until recently. Tumor-treating fields (TTFields) are low-intensity, intermediate frequency, alternating electric fields delivered continuously through adhesive patches, called transducer arrays, to the area of the brain where the GBM tumor is located and help slow down or stop glioblastoma cancer cells from dividing. These transducer arrays are applied to the scalp and are connected to the wearable and portable device.

TTFields are the first treatment since 2005 to demonstrate significantly extended median overall survival and significantly improved long-term survival (one to five year survival rates) compared to the current standard of care. In addition, TTFields significantly extended progression-free survival.

In the Phase 3 trial in newly diagnosed GBM (trial EF-14) the results demonstrated that the addition of TTFields to maintenance TMZ significantly extends both, median and long term survival, as well as progression free survival of patients with newly diagnosed GBM. The magnitude of survival benefit seen is even better to that seen for addition of TMZ to radiation, which established TMZ as the standard of care for 1st line GBM treatment in 2005. Quality of life (QoL) was maintained with the use of TTFields + TMZ in patients for whom 12 months of QoL data were available. The addition of TTFields to TMZ therapy in patients with newly diagnosed glioblastoma was not associated with any significant increase in systemic toxic effects compared with TMZ therapy alone. The most commonly reported side effect from the delivery of TTFields was a mild-to-moderate skin irritation beneath the transducer arrays.


Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Use of TTFields for Newly Diagnosed GBM Patients in Germany in Routine Clinical Care - TIGER Study
Actual Study Start Date : August 31, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
GBM with indication for TTFields
newly diagnosed GBM with clinical indication for TTFields
Device: TTFields
Tumor treating fields (TTFields) help slow down or stop glioblastoma cancer cells from dividing by disrupting dividing mechanism of cancer cells leading to apoptosis. TTFields are low-intensity, intermediate frequency, alternating electric fields delivered continuously through adhesive patches, called transducer arrays, to the area of the brain where the GBM tumor is located. These transducer arrays are applied to the scalp and are connected to the wearable and portable device. TTFields are approved for the treatment of newly diagnosed and recurrent GBM.



Primary Outcome Measures :
  1. Time to death of any cause (overall survival (OS)) from diagnosis [ Time Frame: through study completion, an average of 18 months (mean FU time) ]
    Time to death of any cause (overall survival (OS)) from diagnosis is measured using the patient data from date of enrollment until the date of death from any cause

  2. Number of TTFields treatment-related serious adverse events (SAEs) standardized to one year of FU time [ Time Frame: through study completion, an average of 18 months (mean follow-up time) ]
    Number of TTFields treatment-related SAEs standardized to one year of follow-up (FU) is measured using the collection of SAEs during the follow-up period

  3. Number of SAEs after start of TTFields treatment [ Time Frame: through study completion, an average of 18 months (mean follow-up time) ]
    Number of SAEs after start of TTFields treatment is measured using the collection of SAEs at the follow-up period

  4. Time of usage (compliance) of TTFields treatment over time [ Time Frame: through study completion, an average of 18 months (mean follow-up time) ]
    Time of usage (compliance) of TTFields treatment over time is measured using the treatment compliance report at the Follow-up period

  5. Time to first progression of GBM (progression-free survival (PFS)), defined within radiological and/or clinical/neurological assessment during routine clinical care in patients who started TTFields treatment at baseline [ Time Frame: through study completion, an average of 18 months (mean follow-up time) ]
    Time to first progression of GBM (progression-free survival (PFS)), defined within radiological and/or clinical/neurological assessment during routine clinical care in patients who started TTFields treatment at baseline from date of enrollment until the date of first progression of GBM

  6. Changes in quality of life at month 2 and month 4 after start of TTFields treatment compared to baseline in patients who started TTFields treatment at baseline [ Time Frame: month 2 and month 4 after start of TTFields treatment compared to baseline in patients who started TTFields treatment at baseline ]
    Changes in quality of life assessed via questionnaires EORTC Quality of life questionnaires (QLQ) QLQ-C30 and BN20 after start of TTFields treatment compared to baseline in patients who started TTFields treatment at baseline is measured using the QoL questionnaires at months two and four after start of TTFields treatment

  7. Patients' reason(s) for refusing TTFields at baseline [ Time Frame: baseline ]
    Patients' reason(s) for refusing TTFields is measured using a study specific questionnaire at baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed GBM with clinical indication for TTFields treatment, as indicated by the treating physician, will be included in the study, provided all inclusion and no exclusion criteria are met and written consent is given to use and process their routine clinical data according to data privacy standards.
Criteria

Inclusion Criteria:

  • Newly diagnosed histologically confirmed GBM (WHO-Grade IV)
  • Patient within first 3 cycles of first-line tumor-specific maintenance chemotherapy
  • ≥ 18 years of age
  • Clinical indication for TTFields treatment
  • Given informed consent for use and processing of data

Exclusion Criteria:

  • Present or planned pregnancy
  • Significant additional neurological disease (e.g. significantly increased intracerebral pressure (ICP) with a significant midline shift of the brain)
  • Active implanted medical device (e.g. deep brain stimulator)
  • Documented allergy to conductive hydrogel
  • Skull defect (e.g. missing bone with no replacement, bullet fragments in the skull)

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): NCT03258021


Contacts
Contact: Frieda Zweynert +49 89 990 1649 968 tiger@cri-muc.eu

Locations
Germany
University Hospital Frankfurt Recruiting
Frankfurt am Main, Germany, 60528
Contact: Oliver Bähr, Dr         
Sponsors and Collaborators
NovoCure Ltd.
Investigators
Principal Investigator: Oliver Bähr, Dr. University Hospital Frankfurt, Frankfurt am Main, Germany

Publications:

Responsible Party: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT03258021     History of Changes
Other Study ID Numbers: 05.07.2017
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by NovoCure Ltd.:
Glioblastoma
GBM
Tumor-treating fields
TTFields

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue