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GlioblastomaNCT04717739

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

An observational study of Glioblastoma, run by NovoCure Ltd. at 36 sites in Germany.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
TTFields
Type of treatment
Medical device
How many people
500 participants
Where
36 sitesGermany
Study dates
30 Dec 2021to 1 Feb 2025
Phase
Observational
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

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.

Who may be able to join

  • 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

Who cannot join

  • Any foreseeable deviation from the IFU of NovoTTF-200T Device

Trial locations and contacts

36 sites in 1 country.

Dunja Kosanovic contact

0049 89 990 1649 968

tigerpro@cri-muc.eu

36 sites in 1 country

Germany36 sites, 13 recruiting

  • Universitätsklinikum Aachen

    Aachen, 52074

    Active, not recruiting

  • Klinikum Aschaffenburg-Alzenau

    Aschaffenburg, 63739

    Giles Vince, Prof.

    Recruiting

  • Universitätsklinikum Augsburg (AöR)

    Augsburg, 86156

    Ehab Shiban, Prof.

    Recruiting

  • Universitätsklinikum Bonn

    Bonn, 53127

    Active, not recruiting

  • Klinikum Chemnitz

    Chemnitz, 09116

    Active, not recruiting

  • Uniklinik Köln

    Cologne, 50937

    Active, not recruiting

  • Kliniken der Stadt Köln GmbH

    Cologne, 51109

    Active, not recruiting

  • Carl-Thiem-Klinikum Cottbus

    Cottbus, 03048

    Carsten Schoof, Dr.

    Recruiting

  • Universitätsklinik Carl Gustav Carus Dresden

    Dresden, 01307

    Dietmar Krex, Prof.

    Recruiting

  • Sana Kliniken Duisburg

    Duisburg, 47055

    Active, not recruiting

  • Universitätsklinikum Düsseldorf HHU

    Düsseldorf, 40225

    Active, not recruiting

  • HELIOS Klinikum Erfurt

    Erfurt, 99089

    Rüdiger Gerlach, Prof.

    Recruiting

  • Universitätsklinikum Erlangen

    Erlangen, 91054

    Rainer Fietkau, Prof.

    Recruiting

  • Universitätsklinikum Essen

    Essen, 45147

    Sied Kebir, Dr.

    Recruiting

  • Universitätsklinikum Frankfurt Goethe-Universität

    Frankfurt, 60528

    Active, not recruiting

  • Universitätsmedizin Greifswald

    Greifswald, 17475

    Active, not recruiting

  • BG Klinikum Bergmannstrost Halle

    Halle, 06112

    Anja Glien, Dr.

    Recruiting

  • Onkologische Schwerpunktpraxis Dres. I. Zander und E. von der Heyde

    Hanover, 30161

    Eyck von der Heyde, Dr.

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, 30625

    Active, not recruiting

  • Universitätsklinikum des Saarlandes

    Homburg, 66421

    Active, not recruiting

  • Universitätsklinikum Jena

    Jena, 07747

    Active, not recruiting

  • Klinikum Kassel

    Kassel, 34125

    Active, not recruiting

  • Universitätsklinikum SH Campus Kiel

    Kiel, 24105

    Hajrullah Ahmeti, Dr.

    Recruiting

  • Otto-von-Guericke-Universität Magdeburg

    Magdeburg, 39120

    Active, not recruiting

  • Med. Fakultät Mannheim der Universität Heidelberg

    Mannheim, 68167

    Active, not recruiting

  • Johannes Wesling Klinikum Minden

    Minden, 32429

    Active, not recruiting

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, 41063

    Ursula Nestle, Prof.

    Recruiting

  • Klinikum Nürnberg

    Nuremberg, 90471

    Active, not recruiting

  • Pius-Hospital Oldenburg

    Oldenburg, 26121

    Active, not recruiting

  • Niels-Stensen-Kliniken - Marienhospital Osnabrück

    Osnabrück, 49076

    Suspended

  • Universitätsmedizin Rostock

    Rostock, 18059

    Active, not recruiting

  • HELIOS Kliniken Schwerin GmbH

    Schwerin, 19049

    Active, not recruiting

  • Johanniter-Krankenhaus Genthin-Stendal GmbH

    Stendal, 39576

    Gunnar Lohm, Dr.

    Recruiting

  • Klinikum Stuttgart

    Stuttgart, 70174

    Daniel Sachs, Dr.

    Recruiting

  • Universitätsklinikum Tübingen

    Tübingen, 72076

    Active, not recruiting

  • Paracelsus-Klinik Zwickau

    Zwickau, 08008

    Active, not recruiting

Other trials in Germany

About this study

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

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.

Read the 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.

Conditions
Glioblastoma
Being tested
TTFields
Keywords
Glioblastoma, GBM, Tumor Treating Fields, TTFields, ePRO
Medical subject headings
Glioblastoma

What participants receive

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

  • TTFieldsDevice

    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.

Study groups in NCT04717739
Study groupRoleWhat they receive
GBM with indication for TTFieldsnewly diagnosed GBM with clinical indication for TTFields
Receives: Device: TTFields

What is being measured

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

  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 of usage (compliance) of TTFields treatment over time is measured using the treatment compliance report at the Follow-up period

    Measured: through study completion, an average of 18 months (mean follow-up time)

  2. Number of TTFields treatment-related SAEs as assessed by the CEC standardized to one year of FU 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

    Measured: through study completion, an average of 18 months (mean follow-up time)

  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

    Changes in daily physical activity will be assessed by smartphone app-based clinical monitoring.

    Measured: Up to 4 months after start of TTFields treatment compared to baseline

  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

    Changes in sleep quality will be assessed by smartphone app-based clinical monitoring.

    Measured: Up to 4 months after start of TTFields treatment compared to baseline

  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.

    Changes in neurocognitive functioning will be assessed by means of MoCA interview tests.

    Measured: Up to 4 months after start of TTFields treatment compared to baseline

Timeline

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

  1. First posted22 Jan 2021
  2. Study start30 Dec 2021
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Feb 2025 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04717739
Sponsor's protocol ID
27.09.2021
Status last verified
Jan 2023
First submitted
18 Jan 2021
Last updated
10 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Ostrom QT, Cioffi G, Gittleman H, Patil N, Waite K, Kruchko C, Barnholtz-Sloan JS. CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2012-2016. Neuro Oncol. 2019 Nov 1;21(Suppl 5):v1-v100. doi: 10.1093/neuonc/noz150.

    PubMed 31675094

  • Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.

    PubMed 15758009

  • 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.

    PubMed 25163906

  • Chinot OL, Wick W, Mason W, Henriksson R, Saran F, Nishikawa R, Carpentier AF, Hoang-Xuan K, Kavan P, Cernea D, Brandes AA, Hilton M, Abrey L, Cloughesy T. Bevacizumab plus radiotherapy-temozolomide for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):709-22. doi: 10.1056/NEJMoa1308345.

    PubMed 24552318

  • Gilbert MR, Wang M, Aldape KD, Stupp R, Hegi ME, Jaeckle KA, Armstrong TS, Wefel JS, Won M, Blumenthal DT, Mahajan A, Schultz CJ, Erridge S, Baumert B, Hopkins KI, Tzuk-Shina T, Brown PD, Chakravarti A, Curran WJ Jr, Mehta MP. Dose-dense temozolomide for newly diagnosed glioblastoma: a randomized phase III clinical trial. J Clin Oncol. 2013 Nov 10;31(32):4085-91. doi: 10.1200/JCO.2013.49.6968. Epub 2013 Oct 7.

    PubMed 24101040

  • Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.

    PubMed 26670971

  • Stupp R, Taillibert S, Kanner A, Read W, Steinberg D, Lhermitte B, Toms S, Idbaih A, Ahluwalia MS, Fink K, Di Meco F, Lieberman F, Zhu JJ, Stragliotto G, Tran D, Brem S, Hottinger A, Kirson ED, Lavy-Shahaf G, Weinberg U, Kim CY, Paek SH, Nicholas G, Bruna J, Hirte H, Weller M, Palti Y, Hegi ME, Ram Z. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2306-2316. doi: 10.1001/jama.2017.18718.

    PubMed 29260225

  • Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.

    PubMed 15126372

  • Kirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5.

    PubMed 17551011

  • Gutin PH, Wong ET. Noninvasive application of alternating electric fields in glioblastoma: a fourth cancer treatment modality. Am Soc Clin Oncol Educ Book. 2012:126-31. doi: 10.14694/EdBook_AM.2012.32.122.

    PubMed 24451721

  • Gera N, Yang A, Holtzman TS, Lee SX, Wong ET, Swanson KD. Tumor treating fields perturb the localization of septins and cause aberrant mitotic exit. PLoS One. 2015 May 26;10(5):e0125269. doi: 10.1371/journal.pone.0125269. eCollection 2015.

    PubMed 26010837

  • Giladi M, Schneiderman RS, Voloshin T, Porat Y, Munster M, Blat R, Sherbo S, Bomzon Z, Urman N, Itzhaki A, Cahal S, Shteingauz A, Chaudhry A, Kirson ED, Weinberg U, Palti Y. Mitotic Spindle Disruption by Alternating Electric Fields Leads to Improper Chromosome Segregation and Mitotic Catastrophe in Cancer Cells. Sci Rep. 2015 Dec 11;5:18046. doi: 10.1038/srep18046.

    PubMed 26658786

  • Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbaly V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.

    PubMed 22608262

  • Taphoorn MJB, Dirven L, Kanner AA, Lavy-Shahaf G, Weinberg U, Taillibert S, Toms SA, Honnorat J, Chen TC, Sroubek J, David C, Idbaih A, Easaw JC, Kim CY, Bruna J, Hottinger AF, Kew Y, Roth P, Desai R, Villano JL, Kirson ED, Ram Z, Stupp R. Influence of Treatment With Tumor-Treating Fields on Health-Related Quality of Life of Patients With Newly Diagnosed Glioblastoma: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Apr 1;4(4):495-504. doi: 10.1001/jamaoncol.2017.5082.

    PubMed 29392280

  • Silginer M, Weller M, Stupp R, Roth P. Biological activity of tumor-treating fields in preclinical glioma models. Cell Death Dis. 2017 Apr 20;8(4):e2753. doi: 10.1038/cddis.2017.171.

    PubMed 28425987

Questions about this trial

What is this clinical trial studying?

An observational study of Glioblastoma, run by NovoCure Ltd. at 36 sites in Germany.

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 5 inclusion and 1 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 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Germany. 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.

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?

Contact Dunja Kosanovic (0049 89 990 1649 968, tigerpro@cri-muc.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 5 primary outcomes in all. 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 NCT04717739, which also lists 22 linked publications.

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 10 Jan 2023.

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