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TIGER PRO-Active - Daily Activity, Sleep and Neurocognitive Functioning Study

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ClinicalTrials.gov Identifier: NCT04717739
Recruitment Status : Not yet recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd.

Study Description
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Brief Summary:
This non-interventional study aims to investigate change over time in cognitive function, sleep quality, and activity in daily life as important determinants of QoL in a large cohort of GBM patients in Germany treated with TTFields in routine clinical care using low-threshold, electronic PRO and modern automated tracking data analyses. The gained results will allow even better understanding of TTFields therapy in daily life of GBM patients and consequently, better informing patients about what to expect when starting this therapy, increasing therapy compliance in the long-term.

Condition or disease Intervention/treatment
Glioblastoma Device: TTFields

Detailed Description:

Glioblastoma (GBM) is the most common malignant primary tumor of the brain with an annual incidence of approximately 3/100.000. Since 2005 the treatment for newly diagnosed GBM consisted of maximal surgical resection, approx. 60 Gy of radiotherapy together with chemotherapy using temozolomide (TMZ), followed by 6 cycles of maintenance chemotherapy. This treatment regimen demonstrated increased median overall survival (OS) from 12.1 to 14.6 months in comparison to surgery and radiotherapy alone in 2005.

Since 2005, despite plenty of clinical phase III trials conducted, Tumor Treating Fields (TTFields) therapy was the first treatment shown to significantly increase median progression-free survival (PFS), OS and one to five year survival rates compared to the previous standard of care. These results led to FDA approval of TTFields for newly diagnosed GBM and were acknowledged since then by several guidelines recommending TTFields for GBM therapy (e.g. NCCN guidelines for CNS cancers V.1.2018, RCC guideline tumörer I hjärna och ryggmärg 2020-01-14 V3.0, DGHO guideline for glioma in adults ICD-10 C71 March 2019). Today, several national committees in Europe already list TTFields as reimbursed treatment (e.g. Austria, Sweden, Germany).

Data with TTFields therapy in real-world setting is limited and therefore further evaluation of different treatment aspects of TTFields therapy in clinical routine are of interest. In particular the QoL-related aspects neurocognitive functioning, daily activity and sleep quality in this patient cohort is of major interest, given the limited life expectancy with this disease.

This non-interventional study aims to investigate change over time in neurocognitive functioning, sleep quality, and activity in daily life as important determinants of QoL in a large cohort of GBM patients in Germany treated with TTFields in routine clinical care using low-threshold, electronic PRO and modern automated tracking data analyses. The gained results will allow even better understanding of TTFields therapy in daily life of GBM patients and consequently, better informing patients about what to expect when starting this therapy, increasing therapy compliance even further in the long-term.

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Use of TTFields in Germany in Routine Clinical Care Study PROgram - Daily Activity, Sleep and Neurocognitive Functioning in Newly Diagnosed Glioblastoma Patients Study
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Time of usage of TTFields treatment in follow-up derived from monitoring data of the devices, standardised to usage days, as measure of compliance with TTFields treatment. [ 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

  2. Number of TTFields treatment-related SAEs as assessed by the CEC 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. Changes in daily physical activity as a potential quality of life parameter in TTFields treatment compared to baseline for up to four months after start of TTFields therapy [ Time Frame: Up to 4 months after start of TTFields treatment compared to baseline ]
    Changes in daily physical activity will be assessed by smartphone app-based clinical monitoring.

  4. Changes in sleep quality as a potential quality of life parameter in TTFields treatment compared to baseline for up to four months after start of TTFields therapy [ Time Frame: Up to 4 months after start of TTFields treatment compared to baseline ]
    Changes in sleep quality will be assessed by smartphone app-based clinical monitoring.

  5. Changes in neurocognitive functioning as a potential quality of life parameter in TTFields treatment compared to baseline for up to four months after start of TTFields therapy. [ Time Frame: Up to 4 months after start of TTFields treatment compared to baseline ]
    Changes in neurocognitive functioning will be assessed by means of MoCA interview tests.


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
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed, histologically confirmed GBM and an indication for treatment with NovoTTF-200A System (Optune®) according to IFU and medical guidelines will be enrolled. Patients' written informed consent to use their routine clinical data and app-based monitoring data according to data privacy standards must be obtained prior to documentation of patients' data in the e-CRF.
Criteria

Inclusion Criteria:

  • min.18 years of age
  • Newly diagnosed, histologically confirmed GBM
  • Patient after completion of radiochemotherapy but within first 3 cycles of first-line tumor-specific maintenance chemotherapy
  • Clinical indication of treatment with NovoTTF-200A System (Optune®) according to IFU and medical guidelines
  • Signed informed consent

Exclusion Criteria:

  • Any foreseeable deviation from the IFU of NovoTTF-200A System (Optune®)
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): NCT04717739


Contacts
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Contact: Katharina Holzner 0049 89 990 1649 973 tigerpro@cri-muc.eu

Locations
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Germany
University Hospital Essen
Essen, Germany, 45147
Contact: Martin Glas, Prof.         
Sponsors and Collaborators
NovoCure Ltd.
Investigators
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Principal Investigator: Martin Glas, Prof. University hospital Essen, Essen, Germany
More Information
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Publications:
Stupp R, Hegi ME, Gorlia T, Erridge SC, Perry J, Hong YK, Aldape KD, Lhermitte B, Pietsch T, Grujicic D, Steinbach JP, Wick W, Tarnawski R, Nam DH, Hau P, Weyerbrock A, Taphoorn MJ, Shen CC, Rao N, Thurzo L, Herrlinger U, Gupta T, Kortmann RD, Adamska K, McBain C, Brandes AA, Tonn JC, Schnell O, Wiegel T, Kim CY, Nabors LB, Reardon DA, van den Bent MJ, Hicking C, Markivskyy A, Picard M, Weller M; European Organisation for Research and Treatment of Cancer (EORTC); Canadian Brain Tumor Consortium; CENTRIC study team. Cilengitide combined with standard treatment for patients with newly diagnosed glioblastoma with methylated MGMT promoter (CENTRIC EORTC 26071-22072 study): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2014 Sep;15(10):1100-8. doi: 10.1016/S1470-2045(14)70379-1. Epub 2014 Aug 19.

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Responsible Party: NovoCure Ltd.
ClinicalTrials.gov Identifier: NCT04717739    
Other Study ID Numbers: 13.01.2021
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by NovoCure Ltd.:
Glioblastoma
GBM
Tumor Treating Fields
TTFields
ePRO
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