GlioblastomaTIGERNCT03258021
TTFields In GErmany in Routine Clinical Care
An observational study of Glioblastoma, run by NovoCure Ltd. at 1 site in Germany.
Trial 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. 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
- 710 participants
- Where
- 1 siteGermany
- Study dates
- 31 Aug 2017to Jul 2021
- 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 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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinical center Aschaffenburg-Alzenau
Aschaffenburg, Bavaria, 63739
About this study
Official title: The Use of TTFields for Newly Diagnosed GBM Patients in Germany in Routine Clinical Care - TIGER Study
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.
Read the 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.
- Conditions
- Glioblastoma
- Being tested
- TTFields
- Keywords
- Glioblastoma, GBM, Tumor-treating fields, TTFields
- 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 group | Role | What they receive |
|---|---|---|
| GBM with indication for TTFields | newly 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.
Time to death of any cause (overall survival (OS)) from diagnosis
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
Measured: through study completion, an average of 18 months (mean FU time)
Number of TTFields treatment-related serious adverse events (SAEs) 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)
Number of SAEs after start of TTFields treatment
Number of SAEs after start of TTFields treatment is measured using the collection of SAEs at the follow-up period
Measured: through study completion, an average of 18 months (mean follow-up time)
Time of usage (compliance) of TTFields treatment over time
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)
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 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
Measured: through study completion, an average of 18 months (mean follow-up time)
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
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
Measured: month 2 and month 4 after start of TTFields treatment compared to baseline in patients who started TTFields treatment at baseline
Patients' reason(s) for refusing TTFields at baseline
Patients' reason(s) for refusing TTFields is measured using a study specific questionnaire at baseline
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start31 Aug 2017
- Primary completionJun 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 710 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoCure Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oliver Bähr, Prof., Principal investigator, Clinical center Aschaffenburg-Alzenau, Aschaffenburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258021
- Sponsor's protocol ID
- 05.07.2017
- Acronym
- TIGER
- Status last verified
- Jan 2021
- First submitted
- 2 Aug 2017
- Last updated
- 28 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Dolecek TA, Propp JM, Stroup NE, Kruchko C. CBTRUS statistical report: primary brain and central nervous system tumors diagnosed in the United States in 2005-2009. Neuro Oncol. 2012 Nov;14 Suppl 5(Suppl 5):v1-49. doi: 10.1093/neuonc/nos218. No abstract available.
PubMed 23095881Stupp 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 15758009Stupp 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 26670971Kesari S, Ram Z; EF-14 Trial Investigators. Tumor-treating fields plus chemotherapy versus chemotherapy alone for glioblastoma at first recurrence: a post hoc analysis of the EF-14 trial. CNS Oncol. 2017 Jul;6(3):185-193. doi: 10.2217/cns-2016-0049. Epub 2017 Apr 12.
PubMed 28399638Stupp 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 22608262Mrugala MM, Engelhard HH, Dinh Tran D, Kew Y, Cavaliere R, Villano JL, Annenelie Bota D, Rudnick J, Love Sumrall A, Zhu JJ, Butowski N. Clinical practice experience with NovoTTF-100A system for glioblastoma: The Patient Registry Dataset (PRiDe). Semin Oncol. 2014 Oct;41 Suppl 6:S4-S13. doi: 10.1053/j.seminoncol.2014.09.010. Epub 2014 Sep 16.
PubMed 25213869Kirson 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 17551011Kirson 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 15126372Giladi 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 26658786Gera 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 26010837Kanner AA, Wong ET, Villano JL, Ram Z; EF-11 Investigators. Post Hoc analyses of intention-to-treat population in phase III comparison of NovoTTF-100A system versus best physician's choice chemotherapy. Semin Oncol. 2014 Oct;41 Suppl 6:S25-34. doi: 10.1053/j.seminoncol.2014.09.008. Epub 2014 Sep 16.
PubMed 25213871Stupp 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of TTFields for Newly Diagnosed GBM Patients in Germany in Routine Clinical Care - TIGER Study
- ClinicalTrials.gov ID
- NCT03258021
- Acronym / sponsor ID
- TIGER / 05.07.2017
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, GBM, Tumor-treating fields, TTFields
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 710 participants (actual)
- Lead sponsor
- NovoCure Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GBM with indication for TTFields | – | Device: TTFieldsnewly diagnosed GBM with clinical indication for TTFields |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTFieldsTumor 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. | Device | GBM with indication for TTFields |
Primary outcome
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
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Background: PubMed 23095881Dolecek TA, Propp JM, Stroup NE, Kruchko C. CBTRUS statistical report: primary brain and central nervous system tumors diagnosed in the United States in 2005-2009. Neuro Oncol. 2012 Nov;14 Suppl 5(Suppl 5):v1-49. doi: 10.1093/neuonc/nos218. No abstract available.
- Background: PubMed 15758009Stupp 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.
- Background: PubMed 26670971Stupp 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.
- Background: PubMed 28399638Kesari S, Ram Z; EF-14 Trial Investigators. Tumor-treating fields plus chemotherapy versus chemotherapy alone for glioblastoma at first recurrence: a post hoc analysis of the EF-14 trial. CNS Oncol. 2017 Jul;6(3):185-193. doi: 10.2217/cns-2016-0049. Epub 2017 Apr 12.
- Background: PubMed 22608262Stupp 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.
- Background: PubMed 25213869Mrugala MM, Engelhard HH, Dinh Tran D, Kew Y, Cavaliere R, Villano JL, Annenelie Bota D, Rudnick J, Love Sumrall A, Zhu JJ, Butowski N. Clinical practice experience with NovoTTF-100A system for glioblastoma: The Patient Registry Dataset (PRiDe). Semin Oncol. 2014 Oct;41 Suppl 6:S4-S13. doi: 10.1053/j.seminoncol.2014.09.010. Epub 2014 Sep 16.
- Background: PubMed 17551011Kirson 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.
- Background: PubMed 15126372Kirson 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.
- Background: PubMed 26658786Giladi 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.
- Background: PubMed 26010837Gera 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.
- Background: PubMed 25213871Kanner AA, Wong ET, Villano JL, Ram Z; EF-11 Investigators. Post Hoc analyses of intention-to-treat population in phase III comparison of NovoTTF-100A system versus best physician's choice chemotherapy. Semin Oncol. 2014 Oct;41 Suppl 6:S25-34. doi: 10.1053/j.seminoncol.2014.09.008. Epub 2014 Sep 16.
- Background: PubMed 29260225Stupp 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Bähr, Prof. principal investigator
Clinical center Aschaffenburg-Alzenau, Aschaffenburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by NovoCure Ltd. at 1 site 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 5 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 Jan 2021. 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 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?
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?
Time to death of any cause (overall survival (OS)) from diagnosis (time frame: through study completion, an average of 18 months (mean FU time)). The study lists 7 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 NCT03258021, which also lists 12 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 28 Jan 2021.