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JOURNAL ONKOLOGIE – STUDIE

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

Noch nicht rekrutierend

NCT-Nummer:
NCT04717739

Studienbeginn:
März 2021

Letztes Update:
22.01.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Glioblastoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
NovoCure Ltd.

Collaborator:
-

Studienleiter

Martin Glas, Prof.
Principal Investigator
University hospital Essen, Essen, Germany

Kontakt

Studienlocations
(1 von 1)

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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®)

Studien-Rationale

Primary outcome:

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.

Geprüfte Regime

  • 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.

Quelle: ClinicalTrials.gov


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