Glioblastoma MultiformePhase 2NCT04492163
Open-Label Pilot Study of OPTUNE® With High Density Transducer Arrays for the Treatment of Recurrent GBM
A Phase 2 study testing TTFields in people with Glioblastoma Multiforme, run by NovoCure GmbH at 1 site in Czechia.
Trial summary
This is a prospective, open-label, single arm, historical control pilot study aimed to test the effectiveness and safety of TTFields delivered through high intensity arrays in recurrent glioblastoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- TTFields
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCzechia
- Study dates
- 14 Jul 2020to 20 Jun 2023
- Phase
- Phase 2
- 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
Who may be able to join
- Histologically confirmed diagnosis of GBM according to WHO classification criteria.
- Age ≥ 18 years
- Not a candidate for further radiotherapy or additional resection of residual tumor.
- Patients with first or second radiological disease progression per RANO criteria documented by MRI within 4 weeks prior to starting therapy with the following restriction: disease progression must be either growth of the enhancing lesion or a new lesion.
- Karnofsky performance status ≥ 70
- Life expectancy ≥ least 3 months
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- Participants of childbearing age must use highly effective contraception. An effective method of birth control is defined as one that results in a failure rate of less than 1% per year when used consistently and correctly. The Investigator must approve the selected method, and may consult with a gynecologist as needed.
- All patients must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
- Treatment start date at least 4 weeks out from brain surgery chemotherapy or irradiation therapy.
Who cannot join
- Infratentorial or leptomeningeal disease
- Treatment with Optune® (for newly diagnosed or recurrent disease) prior to enrollment.
- Participation in another clinical treatment study during screening and treatment phase of the study.
- Pregnancy or breast-feeding.
- Significant co-morbidities at baseline, as determined by the investigator:
- Thrombocytopenia (platelet count < 100 x 103/μL)
Show all 17Show fewer
- Neutropenia (absolute neutrophil count < 1 x 103/μL)
- CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
- Significant liver function impairment - AST or ALT > 3 times the upper limit of normal
- Total bilirubin > 1.5 x upper limit of normal
- Significant renal impairment (serum creatinine > 1.7 mg/dL, or > 150 µmol/l)
- History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent
- Implanted pacemaker, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
- Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
- Admitted to an institution by administrative or court order.
- Known allergies to medical adhesives or hydrogel
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EF-33: An Open-Label Pilot Study of OPTUNE® (TTFields, 200 Khz) With High Density Transducer Arrays for the Treatment of Recurrent Glioblastoma
This is a prospective, open-label, single arm, historical control pilot study aimed to test the effectiveness and safety of TTFields delivered through high intensity arrays in recurrent glioblastoma.
The Optune® System is an investigational , portable, battery operated medical device in this study delivering 200 kHz TTFields to the brain using high intensity transducer arrays for the treatment of patients at the age of 18 years or older with first or second recurrence of Glioblastoma Multiforme (GBM)
Read the detailed description
Optune® is a medical device that has been approved for the treatment of recurrent and newly diagnosed glioblastoma (GBM) by the Food and Drug Administration (FDA) in the United States. Optune® has obtained a CE mark in Europe for recurrent and newly diagnosed GBM.
TTFields intensity has been shown to be positively correlated with patient outcome. The new transducer array design is expected to reduce skin heating and thus enable delivery of higher TTFields intensities while keeping the safety profile of the treatment unchanged.
The purpose of the study is to test if delivering TTFields using high intensity transducer arrays for recurrent GBM significantly improves the clinical outcome of patients, compared to using the standard transducer arrays.
The study will enroll 25 patients.
All patients included in this clinical investigation are patients with histologically confirmed diagnosis of GBM with first or second radiological disease progression per RANO criteria.
In addition, all patients must meet all eligibility criteria.
Baseline assessments will be performed to confirm patient eligibility in the study.
Enrolled patients will be treated continuously with the device until disease progression per RANO criteria or 18 months (the earlier of the two) unless any of the treatment discontinuation conditions described under criteria for patient withdrawal or termination are met.
Concurrent brain directed antitumor therapy or procedures beyond TTFields is prohibited.
TTFields treatment will start within 28 days following signing the informed consent.
After the initial visit, subjects will continue treatment at home, while pursuing normal daily routines. Subjects are required to use the device for at least 18 hours a day. Short breaks in treatment for personal hygiene and other personal needs is allowed. Total usage time will be recorded and provided to the sponsor.
Subjects will be required to return to the clinic every 4 weeks and every 8 weeks after first 12 visits, until disease progression. At each study visit an examination by a physician and a routine laboratory examination will be performed.
A contrast enhanced MRI of the head will be performed at baseline and every 4 weeks for the first 24 weeks and then at least every 12 weeks, until disease progression.
A post-treatment termination visit will be performed approximately 30 days after discontinuation of TTfields treatment or disease progression (the latter of the two).
Following disease progression, subjects will be contacted once per month by telephone to answer basic questions about their health status.
Pathological analysis of GBM tumor samples, which may be obtained prior and during the study period, will be performed based on subjects' consent to have an experimental pathological examination of their tumors.
- Conditions
- Glioblastoma Multiforme
- Being tested
- TTFields
- Keywords
- Glioblastoma Multiforme, Recurrent Glioblastoma, GBM, Treatment, Minimal Toxicity, TTFields, Tumor Treating Fields, NovoCure
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTFieldsDevice
TTFields treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine.
Other Names:
- TTFields
| Study group | Role | What they receive |
|---|---|---|
| Experimental: TTFields | Experimental | Patients receive continuous TTFields treatment using the Optune® System with high intensity transducer arrays. Receives: Device: TTFields |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
PFS will be measured from the date of enrollment to date of progression (in months) based on RANO citeria.
Measured: 18 Months
Secondary outcomes (8)
Overall Survival (OS)
Survival will be measured from date of enrollment until date of death.
Measured: 18 Months
Progression Free Survival at 6 months (PFS6)
The analysis will be estimated proportions of patients who are progression-free at 6 months based on the RANO criteria following the time of enrollment.
Measured: 18 Months
1-year and 2-year survival rates
The analyses will be performed based on estimated proportions of patients who are alive at one and two years following enrollment.
Measured: 24 Months
Overall radiological response
The percentage of patients who had either complete response or partial response per RANO criteria following enrollment
Measured: 18 Months
Severity and frequency of adverse events
The analyses will be performed based on the incidence, severity, frequency of adverse events, and their association with study treatments
Measured: 18 Months
Pathological changes in resected GBM tumors following study treatment
Pathological changes in the tumors of patients who consented to have pathological analysis of their tumors and also underwent another surgical resection while on the study
Measured: 18 Months
Dependence of Progression Free Survival on TTFields dose delivered to the tumor bed
Measured: 18 months
Dependence of Overall Survival on TTFields dose delivered to the tumor bed
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start14 Jul 2020
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
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 Glioblastoma MultiformeStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoCure GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josef Vymazal, MD, DSc, Principal investigator, Nemocnice Na Homolce (Na Homolce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492163
- Sponsor's protocol ID
- EF-33
- Status last verified
- May 2024
- First submitted
- 27 Jul 2020
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wen PY, Macdonald DR, Reardon DA, Cloughesy TF, Sorensen AG, Galanis E, Degroot J, Wick W, Gilbert MR, Lassman AB, Tsien C, Mikkelsen T, Wong ET, Chamberlain MC, Stupp R, Lamborn KR, Vogelbaum MA, van den Bent MJ, Chang SM. Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol. 2010 Apr 10;28(11):1963-72. doi: 10.1200/JCO.2009.26.3541. Epub 2010 Mar 15.
PubMed 20231676Stupp 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 29260225Giladi 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 26658786Kirson 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, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.
PubMed 19387848Kirson 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 15126372Stupp 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 22608262Pless M, Weinberg U. Tumor treating fields: concept, evidence and future. Expert Opin Investig Drugs. 2011 Aug;20(8):1099-106. doi: 10.1517/13543784.2011.583236. Epub 2011 May 9.
PubMed 21548832Mun EJ, Babiker HM, Weinberg U, Kirson ED, Von Hoff DD. Tumor-Treating Fields: A Fourth Modality in Cancer Treatment. Clin Cancer Res. 2018 Jan 15;24(2):266-275. doi: 10.1158/1078-0432.CCR-17-1117. Epub 2017 Aug 1.
PubMed 28765323Giladi M, Munster M, Schneiderman RS, Voloshin T, Porat Y, Blat R, Zielinska-Chomej K, Haag P, Bomzon Z, Kirson ED, Weinberg U, Viktorsson K, Lewensohn R, Palti Y. Tumor treating fields (TTFields) delay DNA damage repair following radiation treatment of glioma cells. Radiat Oncol. 2017 Dec 29;12(1):206. doi: 10.1186/s13014-017-0941-6.
PubMed 29284495Taphoorn 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 29392280Ballo MT, Urman N, Lavy-Shahaf G, Grewal J, Bomzon Z, Toms S. Correlation of Tumor Treating Fields Dosimetry to Survival Outcomes in Newly Diagnosed Glioblastoma: A Large-Scale Numerical Simulation-Based Analysis of Data from the Phase 3 EF-14 Randomized Trial. Int J Radiat Oncol Biol Phys. 2019 Aug 1;104(5):1106-1113. doi: 10.1016/j.ijrobp.2019.04.008. Epub 2019 Apr 23.
PubMed 31026557
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EF-33: An Open-Label Pilot Study of OPTUNE® (TTFields, 200 Khz) With High Density Transducer Arrays for the Treatment of Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT04492163
- Acronym / sponsor ID
- EF-33
- Conditions
- Glioblastoma Multiforme
- Keywords
- Glioblastoma Multiforme, Recurrent Glioblastoma, GBM, Treatment, Minimal Toxicity, TTFields, Tumor Treating Fields, NovoCure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- NovoCure GmbHIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 30 Jul 2020 (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.
This is a prospective, open-label, single arm, historical control pilot study aimed to test the effectiveness and safety of TTFields delivered through high intensity arrays in recurrent glioblastoma.
The Optune® System is an investigational , portable, battery operated medical device in this study delivering 200 kHz TTFields to the brain using high intensity transducer arrays for the treatment of patients at the age of 18 years or older with first or second recurrence of Glioblastoma Multiforme (GBM)
Detailed description
Optune® is a medical device that has been approved for the treatment of recurrent and newly diagnosed glioblastoma (GBM) by the Food and Drug Administration (FDA) in the United States. Optune® has obtained a CE mark in Europe for recurrent and newly diagnosed GBM.
TTFields intensity has been shown to be positively correlated with patient outcome. The new transducer array design is expected to reduce skin heating and thus enable delivery of higher TTFields intensities while keeping the safety profile of the treatment unchanged.
The purpose of the study is to test if delivering TTFields using high intensity transducer arrays for recurrent GBM significantly improves the clinical outcome of patients, compared to using the standard transducer arrays.
The study will enroll 25 patients.
All patients included in this clinical investigation are patients with histologically confirmed diagnosis of GBM with first or second radiological disease progression per RANO criteria.
In addition, all patients must meet all eligibility criteria.
Baseline assessments will be performed to confirm patient eligibility in the study.
Enrolled patients will be treated continuously with the device until disease progression per RANO criteria or 18 months (the earlier of the two) unless any of the treatment discontinuation conditions described under criteria for patient withdrawal or termination are met.
Concurrent brain directed antitumor therapy or procedures beyond TTFields is prohibited.
TTFields treatment will start within 28 days following signing the informed consent.
After the initial visit, subjects will continue treatment at home, while pursuing normal daily routines. Subjects are required to use the device for at least 18 hours a day. Short breaks in treatment for personal hygiene and other personal needs is allowed. Total usage time will be recorded and provided to the sponsor.
Subjects will be required to return to the clinic every 4 weeks and every 8 weeks after first 12 visits, until disease progression. At each study visit an examination by a physician and a routine laboratory examination will be performed.
A contrast enhanced MRI of the head will be performed at baseline and every 4 weeks for the first 24 weeks and then at least every 12 weeks, until disease progression.
A post-treatment termination visit will be performed approximately 30 days after discontinuation of TTfields treatment or disease progression (the latter of the two).
Following disease progression, subjects will be contacted once per month by telephone to answer basic questions about their health status.
Pathological analysis of GBM tumor samples, which may be obtained prior and during the study period, will be performed based on subjects' consent to have an experimental pathological examination of their tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental: TTFields | Experimental | Device: TTFieldsPatients receive continuous TTFields treatment using the Optune® System with high intensity transducer arrays. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed diagnosis of GBM according to WHO classification criteria.
- Age ≥ 18 years
- Not a candidate for further radiotherapy or additional resection of residual tumor.
- Patients with first or second radiological disease progression per RANO criteria documented by MRI within 4 weeks prior to starting therapy with the following restriction: disease progression must be either growth of the enhancing lesion or a new lesion.
- Karnofsky performance status ≥ 70
Key exclusion criteria (17 listed)
- Infratentorial or leptomeningeal disease
- Treatment with Optune® (for newly diagnosed or recurrent disease) prior to enrollment.
- Participation in another clinical treatment study during screening and treatment phase of the study.
- Pregnancy or breast-feeding.
- Significant co-morbidities at baseline, as determined by the investigator:
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 |
|---|---|---|
| TTFieldsTTFields treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine. Other Names: • TTFields | Device | Experimental: TTFields |
Primary outcome
Progression free survival (PFS)
Time frame: 18 Months
PFS will be measured from the date of enrollment to date of progression (in months) based on RANO citeria.
8 secondary outcomes
Overall Survival (OS)
Time frame: 18 Months
Progression Free Survival at 6 months (PFS6)
Time frame: 18 Months
1-year and 2-year survival rates
Time frame: 24 Months
Overall radiological response
Time frame: 18 Months
Severity and frequency of adverse events
Time frame: 18 Months
Pathological changes in resected GBM tumors following study treatment
Time frame: 18 Months
Dependence of Progression Free Survival on TTFields dose delivered to the tumor bed
Time frame: 18 months
Dependence of Overall Survival on TTFields dose delivered to the tumor bed
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Background: PubMed 20231676Wen PY, Macdonald DR, Reardon DA, Cloughesy TF, Sorensen AG, Galanis E, Degroot J, Wick W, Gilbert MR, Lassman AB, Tsien C, Mikkelsen T, Wong ET, Chamberlain MC, Stupp R, Lamborn KR, Vogelbaum MA, van den Bent MJ, Chang SM. Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol. 2010 Apr 10;28(11):1963-72. doi: 10.1200/JCO.2009.26.3541. Epub 2010 Mar 15.
- 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.
- 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 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 19387848Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.
- 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 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 21548832Pless M, Weinberg U. Tumor treating fields: concept, evidence and future. Expert Opin Investig Drugs. 2011 Aug;20(8):1099-106. doi: 10.1517/13543784.2011.583236. Epub 2011 May 9.
- Background: PubMed 28765323Mun EJ, Babiker HM, Weinberg U, Kirson ED, Von Hoff DD. Tumor-Treating Fields: A Fourth Modality in Cancer Treatment. Clin Cancer Res. 2018 Jan 15;24(2):266-275. doi: 10.1158/1078-0432.CCR-17-1117. Epub 2017 Aug 1.
- Background: PubMed 29284495Giladi M, Munster M, Schneiderman RS, Voloshin T, Porat Y, Blat R, Zielinska-Chomej K, Haag P, Bomzon Z, Kirson ED, Weinberg U, Viktorsson K, Lewensohn R, Palti Y. Tumor treating fields (TTFields) delay DNA damage repair following radiation treatment of glioma cells. Radiat Oncol. 2017 Dec 29;12(1):206. doi: 10.1186/s13014-017-0941-6.
- Background: PubMed 29392280Taphoorn 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.
- Background: PubMed 31026557Ballo MT, Urman N, Lavy-Shahaf G, Grewal J, Bomzon Z, Toms S. Correlation of Tumor Treating Fields Dosimetry to Survival Outcomes in Newly Diagnosed Glioblastoma: A Large-Scale Numerical Simulation-Based Analysis of Data from the Phase 3 EF-14 Randomized Trial. Int J Radiat Oncol Biol Phys. 2019 Aug 1;104(5):1106-1113. doi: 10.1016/j.ijrobp.2019.04.008. Epub 2019 Apr 23.
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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.
Josef Vymazal, MD, DSc principal investigator
Nemocnice Na Homolce (Na Homolce Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TTFields in people with Glioblastoma Multiforme, run by NovoCure GmbH at 1 site in Czechia.
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 9 inclusion and 17 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: finished, as of the sponsor's last update on 16 Aug 2024. 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 Czechia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression free survival (PFS) (time frame: 18 Months). 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 NCT04492163, 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 16 Aug 2024.