Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC).

NCT ID: NCT02831959

Last Updated: 2025-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

298 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2024-11-29

Brief Summary

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The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1 inoperable brain metastasis or 2-10 brain metastases, treated with NovoTTF-200M and supportive treatment compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

Detailed Description

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PAST PRE-CLINICAL AND CLINICAL EXPERIENCE:

The effect of the electric fields (TTFields, TTF) has demonstrated significant activity in in vitro and in vivo NSCLC pre-clinical models both as a single modality treatment and in combination with chemotherapies. TTFields have also shown to inhibit metastatic spread of malignant melanoma in in vivo experiment.

In a pilot study, 42 patients with advanced NSCLC who had tumor progression after at least one line of prior chemotherapy, received pemetrexed together with TTFields (150 kHz) applied to the chest and upper abdomen until disease progression (Pless M., et al., Lung Cancer 2011). Efficacy endpoints were remarkably high compared to historical data for pemetrexed alone.

In addition, a phase III trial of Optune® (200 kHz) as monotherapy compared to active chemotherapy in recurrent glioblastoma patients showed TTFields to be equivalent to active chemotherapy in extending survival, associated with minimal toxicity, good quality of life, and activity within the brain (14% response rate) (Stupp R., et al., EJC 2012). Finally, a phase III trial of Optune® combined with maintenance temozolomide compared to maintenance temozolomide alone has shown that combined therapy led to a significant improvement in both progression free survival and overall survival in patients with newly diagnosed glioblastoma without the addition of high grade toxicity and without decline in quality of life (Stupp R., et al., JAMA 2015).

Applying TTFields at 150 kHz to the brain for the treatment of 1-5 brain metastasis from NSCLC using the NovoTTF-100M device has been demonstrated to be safe in a pilot study, where patients were randomized after local therapy of their brain metastasis by neurosurgery and/or stereotactic radiosurgery to receive either NovoTTF-100M treatment or supportive care alone. Eighteen (18) patients have been enrolled in the study. There have been no device-related serious adverse events (SAE) reported to date (Brozova H., et al., Neuro Oncol 2016).

DESCRIPTION OF THE TRIAL:

All patients included in this trial are patients with 1-10 brain metastases from NSCLC which are amenable to stereotactic radiosurgery (SRS). In addition, all patients must meet all eligibility criteria.

Eligible patients will be randomly assigned to one of two groups:

1. Patients undergo SRS followed by TTFields using the NovoTTF-200M System
2. Patients undergo SRS alone and receive supportive care. Patients in both arms of the study may receive systemic therapy for their NSCLC at the discretion of their treating physician.

Patients will be randomized at a 1:1 ratio. Baseline tests will be performed in patients enrolled in both arms. If assigned to the NovoTTF-200M group, the patients will be treated continuously with the device until second intracranial progression.

On both arms, patients who recur anywhere in the brain will be offered one of the following salvage treatments (according to local practice) including, but not limited to:

* Surgery
* Repeat SRS
* Whole brain radiotherapy (WBRT) Patients on the control arm will be offered to cross over to the NovoTTF-200M arm of the study and receive TTFields with or without salvage therapy for second intracranial progression if the investigator believes it is in the best interest of the patient and patient agrees.

SCIENTIFIC BACKGROUND:

Electric fields exert forces on electric charges similar to the way a magnet exerts forces on metallic particles within a magnetic field. These forces cause movement and rotation of electrically charged biological building blocks, much like the alignment of metallic particles seen along the lines of force radiating outwards from a magnet.

Electric fields can also cause muscles to twitch and if strong enough may heat tissues. TTFields are alternating electric fields of low intensity. This means that they change their direction repetitively many times a second. Since they change direction very rapidly (150 thousand times a second), they do not cause muscles to twitch, nor do they have any effects on other electrically activated tissues in the body (brain, nerves and heart). Since the intensities of TTFields in the body are very low, they do not cause heating.

The breakthrough finding made by Novocure was that finely tuned alternating fields of very low intensity, now termed TTFields (Tumor Treating Fields), cause a significant slowing in the growth of cancer cells. Due to the unique geometric shape of cancer cells when they are multiplying, TTFields cause electrically- charged cellular components of these cells to change their location within the dividing cell, disrupting their normal function and ultimately leading to cell death.. In addition, cancer cells also contain miniature building blocks which act as tiny motors in moving essential parts of the cells from place to place. TTFields interfere with the normal orientation of these tiny motors related to other cellular components since they are electrically-charged as well. As a result of these two effects, tumor cell division is slowed, results in cellular death or reverses after continuous exposure to TTFields.

Other cells in the body (normal healthy tissues) are affected much less than cancer cells since they multiply at a much slower rate if at all. In addition TTFields can be directed to a certain part of the body, leaving sensitive areas out of their reach. Finally, the frequency of TTFields applied to each type of cancer is specific and may not damage normally dividing cells in healthy tissues. In conclusion, TTFields hold the promise of serving as a brand new treatment for brain metastases from NSCLC with very few side effects.

Conditions

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Brain Metastases From Non-small Cell Lung Cancer (NSCLC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NovoTTF-200M device

NovoTTF-200M device Patients undergo SRS followed by continuous TTFields treatment using the NovoTTF-200M device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the head.

The treatment enables the patient to maintain regular daily routine.

Group Type EXPERIMENTAL

NovoTTF-200M device

Intervention Type DEVICE

Best Standard of Care

Intervention Type OTHER

Best Standard of Care

Patients will undergo SRS alone and be treated with the best known standard of care for Non-Small Cell Lung Cancer metastatic to the brain.

Group Type ACTIVE_COMPARATOR

Best Standard of Care

Intervention Type OTHER

Interventions

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NovoTTF-200M device

Intervention Type DEVICE

Best Standard of Care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 18 years of age and older
2. Life expectancy of ≥ 3 months
3. New diagnosis of brain metastases from a histologically or cytologically confirmed primary or metastatic NSCLC tumor within 5 years of registration on the study. If the original histological proof of malignancy is greater than 5 years, then pathological confirmation is required (i.e.: from extra-cranial or intracranial disease).

5\. 1 inoperable brain metastasis or 2- 10 brain lesions per screening MRI, confirmed by contrast enhanced MRI amenable to SRS according to the following criteria:

a. largest tumor volume \< 10 cc b. longest tumor diameter \< 3 cm c. Cumulative volume of all tumors ≤ 15 cc 6. At least one measurable disease per study protocol 7. Patients must be receiving optimal therapy for their extracranial disease according to local practice at each center. Patients may continue on systemic therapy while receiving TTFields.

8\. Able to operate the NovoTTF-200M device independently or with the help of a caregiver 9. Clinical trials prior to enrollment are allowed, as long as no brain directed therapy was included (current treatment trials are exclusionary)

Exclusion Criteria

1. Patients who are known to have somatic tumor mutations in the following genes, for which targeted agents are available that directly affect the treatment of brain metastasis: Anaplastic lymphoma kinase (ALK), epidermal growth factor receptor (EGFR), ROS-1 proto- oncogene, and proto-oncogene B-RAF
2. Patients who have a single, operable brain metastasis
3. Patients with significant edema leading to risk of brain herniation
4. Patients with midline shift \> 10mm
5. Patients with intractable seizures
6. Leptomeningeal metastases
7. Recurrent brain metastases
8. Prior WBRT for newly diagnosed brain metastases
9. Severe comorbidities:

1. Clinically-significant inadequate hematological, hepatic and renal function, defined as: Neutrophil count \< 1.5 x 10 9/L and platelet count \< 100 x 10\^9/L; bilirubin \> 1.5 x upper limit of normal (ULN); aspartate transaminase (AST) and/or alanine aminotransferase (ALT) \> 2.5 x ULN or \> 5 x ULN if patient has documented liver metastases; and serum creatinine \> 1.5 x ULN
2. History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/ third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea).
3. History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the study.
4. History of cerebrovascular accident (CVA) within 6 months prior to randomization or that is not stable
5. Active infection or serious underlying medical condition that would impair the ability of the patient to received protocol therapy
6. 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
10. Implantable electronic medical devices in the brain
11. Known allergies to medical adhesives or hydrogel
12. Currently pregnant or breastfeeding
13. Planned concurrent brain directed therapy (beyond SRS and NovoTTF-200M as per protocol)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NovoCure GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minesh Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

Miami Cancer Institute, Miami FL USA

Paul Brown, MD

Role: PRINCIPAL_INVESTIGATOR

MD Anderson Cancer Center, Houston TX USA

Vinai Gondi, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern Medicine Cancer Center, Warenville IL USA

Manmeet Ahluwalia, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Cleveland OH USA

Locations

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University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Site Status

Grandview Medical Center - Cancer Center

Birmingham, Alabama, United States

Site Status

Infirmary Cancer Care

Mobile, Alabama, United States

Site Status

Barrow Neurological Institute

Phoenix, Arizona, United States

Site Status

Mayo Clinic Phoenix

Phoenix, Arizona, United States

Site Status

MemorialCare Cancer Institute

Long Beach, California, United States

Site Status

The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange

Orange, California, United States

Site Status

Kaiser Permanente Redwood City

Redwood City, California, United States

Site Status

Dignity Health - Mercy Cancer Centers

Sacramento, California, United States

Site Status

Kaiser Permanente - Sacramento

Sacramento, California, United States

Site Status

Sharp HealthCare

San Diego, California, United States

Site Status

University of California

San Francisco, California, United States

Site Status

St. Mary's Medical Center - Grand Junction

Grand Junction, Colorado, United States

Site Status

Banner North Colorado Medical Center (NCMC) - Oncology - Greeley

Greeley, Colorado, United States

Site Status

Banner MD Anderson Cancer Center - McKee Medical Center

Loveland, Colorado, United States

Site Status

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Site Status

UF Health Jacksonville

Jacksonville, Florida, United States

Site Status

Mayo Clinic

Jacksonville, Florida, United States

Site Status

Miami Cancer Institute

Miami, Florida, United States

Site Status

Adult Oncology Research

Orlando, Florida, United States

Site Status

UF Health Cancer Center

Orlando, Florida, United States

Site Status

BRCR Medical Center INC

Plantation, Florida, United States

Site Status

Piedmont Brain Tumor Center

Atlanta, Georgia, United States

Site Status

Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status

CDH-Delnor Health System

Warrenville, Illinois, United States

Site Status

University of Kansas Cancer Center and Medical Pavilion

Kansas City, Kansas, United States

Site Status

University of Kentucky HealthCare

Lexington, Kentucky, United States

Site Status

University of Louisville-James Graham Brown Cancer Center

Louisville, Kentucky, United States

Site Status

Ochsner Health System

New Orleans, Louisiana, United States

Site Status

Willis-Knighton Cancer Center

Shreveport, Louisiana, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

Site Status

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Abbott Northwestern Hospital - Givens Brain Tumor Center

Minneapolis, Minnesota, United States

Site Status

John Nasseff Neuroscience Institute ANW Brain Tumor Center

Minneapolis, Minnesota, United States

Site Status

University of Minnesota Medical Center (UMMC) - Fairview - Masonic Cancer Clinic

Minneapolis, Minnesota, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Ellis Fischel Cancer Center, University of Missouri Healthcare

Columbia, Missouri, United States

Site Status

Oncology Research | Mercy Research

St Louis, Missouri, United States

Site Status

Renown Regional Medical Center

Reno, Nevada, United States

Site Status

MD Anderson Cancer Center at Cooper

Camden, New Jersey, United States

Site Status

UNC - Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Site Status

Vidant Medical Center

Greenville, North Carolina, United States

Site Status

Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

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Providence St. Vincent Medical Center

Portland, Oregon, United States

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Geisinger Medical Center

Danville, Pennsylvania, United States

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Rhode Island Hospital

Providence, Rhode Island, United States

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Medical University of South Carolina- Hollings Cancer Center

Charleston, South Carolina, United States

Site Status

Prisma Health - Upstate

Greenville, South Carolina, United States

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Erlanger Baroness Hospital

Chattanooga, Tennessee, United States

Site Status

West Cancer Center

Germantown, Tennessee, United States

Site Status

Mischer Neuroscience Associates - Texas Medical Center

Houston, Texas, United States

Site Status

Houston Methodist Hospital

Houston, Texas, United States

Site Status

Texas Oncology

McKinney, Texas, United States

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Texas Oncology

Plano, Texas, United States

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Baylor Scott & White Medical Center - Temple

Waco, Texas, United States

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University of Washington Medical Center

Seattle, Washington, United States

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Aurora Research Institute

Milwaukee, Wisconsin, United States

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Medizinische Universität Innsbruck

Innsbruck, , Austria

Site Status

UMHAT Sv. Ivan Rilski EAD, Department of Medical Oncology

Sofia, , Bulgaria

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University Multiprofile Hospital for Active Treatment Sofiamed, Department of Medical Oncology

Sofia, , Bulgaria

Site Status

Cancercare Manitoba

Winnipeg, Manitoba, Canada

Site Status

Le CIUSSS de I'Est-de-L'ile de Montreal - Hôpital Maisonneuve Rosemont

Montreal, Quebec, Canada

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Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

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Jewish General Hospital

Montreal, Quebec, Canada

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(CHUS) Centre Hospitalier Universitaire de Sherbrooke, Service de Neurochirurgie

Sherbrooke, Quebec, Canada

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Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Chaoyang, China

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The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

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Hubei Cancer Hospital

Wuhan, Hubei, China

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Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

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Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

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The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

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Liaoning Cancer Hospital

Shenyang, Liaoning, China

Site Status

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status

Qilu Hospital of Shandong University

Jinan, Shandong, China

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Shandong Cancer Hospital

Jinan, Shandong, China

Site Status

Qingdao Central Hospital

Qingdao, Shandong, China

Site Status

Zigong Fourth People's Hospital

Zigong, Sichuan, China

Site Status

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status

Fudan University Shanghai Cancer Center

Shanghai, Xuhui District, China

Site Status

Taizhou Hospital, Zhejiang Province

Zhejiang, Zhejiang, China

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Peking University Third Hospital

Beijing, , China

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The First Hospital of Jilin University

Changchun, , China

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The Second Affiliated Hospital Of Xingtai Medical College

Hebei, , China

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The First Hospital of China Medical University

Shenyang, , China

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The University of Hong Kong-Shenzhen Hospital

Shenzhen, , China

Site Status

The First Affiliated Hospital of Xiamen University

Xiamen, , China

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Radiochirugia Zagreb

Sveta Nedelja, , Croatia

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University Hospital Lille

Lille, , France

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Clairval Hospital Center

Marseille, , France

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Hopital Pitié-Salpétriere

Paris, , France

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Centre Hospitalier Universitaire de Saint-Étienne

Saint-Etienne, , France

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Klinik für Radioonkologie und Strahlentherapie der Charité Universitätsmedizin Berlin Campus Charité Virchow-Klinikum

Berlin, , Germany

Site Status

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Site Status

Dr. Senckenbergisches Institut for Neurooncology,

Frankfurt am Main, , Germany

Site Status

Dr. Senckenbergisches Institut für Neuroonkologie, Zentrum der Neurologie und Neurochirurgie

Frankfurt am Main, , Germany

Site Status

Universitätsklinikum Halle (Saale), Klinik für Innere Medizin IV, Hämatologie / Onkologie

Halle, , Germany

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Heidelberg University Clinic for Radiooncology and Radiation Therapy

Heidelberg, , Germany

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Queen Mary Hospital

Hong Kong, , Hong Kong

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National Koranyi Institute of Tb and Pulmonology

Budapest, , Hungary

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Onkologiai Osztaly, Balassa Janos Korhaz

Szekszárd, , Hungary

Site Status

Geza Hetenyi Hospital-Clinic of Jasz-Nagykun-Szolnok County

Szolnok, , Hungary

Site Status

Rambam Medical Center

Haifa, , Israel

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Rabin Medical Center

Petah Tikva, , Israel

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Sourasky Medical Center

Tel Aviv, , Israel

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A.O.S.G. Moscati Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità

Avellino, , Italy

Site Status

General Hospital Gavazzeni

Bergamo, , Italy

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Radioterapia Oncologica AOU Careggi

Florence, , Italy

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Azienda Socio Sanitaria Territoriale di Lecco

Lecco, , Italy

Site Status

University Hospital of Messina AOU Policlinico "G. Martino"

Messina, , Italy

Site Status

The IRCCS Carlo Besta Neurological Institute Foundation

Milan, , Italy

Site Status

A.O.U Città della Salute e della Scienza di Torino

Torino, , Italy

Site Status

Marek Harat Private Practice, Neurosurgery and Radiation Oncology

Bydgoszcz, , Poland

Site Status

University Clinical Center

Gdansk, , Poland

Site Status

Maria Sklodowska-Curie National Research Institute of Oncology

Gliwice, , Poland

Site Status

MS Clinsearch Sp. z.o.o.

Lublin, , Poland

Site Status

Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

Poznan, , Poland

Site Status

Gamma Knife Center Warsaw

Warsaw, , Poland

Site Status

Center for Neuro-oncology, Neurosurgery Clinic, Clinical Center of Serbia

Belgrade, , Serbia

Site Status

Catalan Institute of Oncology

Barcelona, , Spain

Site Status

Hospital Universitario HM Sanchinarro Edificio CIOCC

Madrid, , Spain

Site Status

Clinica Universidad de Navarra

Pamplona, , Spain

Site Status

Countries

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United States Austria Bulgaria Canada China Croatia France Germany Hong Kong Hungary Israel Italy Poland Serbia Spain

References

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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.

Reference Type BACKGROUND
PMID: 15126372 (View on PubMed)

Kirson 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.

Reference Type BACKGROUND
PMID: 19387848 (View on PubMed)

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.

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PMID: 22608262 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26658786 (View on PubMed)

Giladi M, Weinberg U, Schneiderman RS, Porat Y, Munster M, Voloshin T, Blatt R, Cahal S, Itzhaki A, Onn A, Kirson ED, Palti Y. Alternating electric fields (tumor-treating fields therapy) can improve chemotherapy treatment efficacy in non-small cell lung cancer both in vitro and in vivo. Semin Oncol. 2014 Oct;41 Suppl 6:S35-41. doi: 10.1053/j.seminoncol.2014.09.006. Epub 2014 Sep 8.

Reference Type BACKGROUND
PMID: 25213867 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17551011 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26670971 (View on PubMed)

Pless M, Droege C, von Moos R, Salzberg M, Betticher D. A phase I/II trial of Tumor Treating Fields (TTFields) therapy in combination with pemetrexed for advanced non-small cell lung cancer. Lung Cancer. 2013 Sep;81(3):445-450. doi: 10.1016/j.lungcan.2013.06.025. Epub 2013 Jul 23.

Reference Type BACKGROUND
PMID: 23891283 (View on PubMed)

Lin NU, Lee EQ, Aoyama H, Barani IJ, Barboriak DP, Baumert BG, Bendszus M, Brown PD, Camidge DR, Chang SM, Dancey J, de Vries EG, Gaspar LE, Harris GJ, Hodi FS, Kalkanis SN, Linskey ME, Macdonald DR, Margolin K, Mehta MP, Schiff D, Soffietti R, Suh JH, van den Bent MJ, Vogelbaum MA, Wen PY; Response Assessment in Neuro-Oncology (RANO) group. Response assessment criteria for brain metastases: proposal from the RANO group. Lancet Oncol. 2015 Jun;16(6):e270-8. doi: 10.1016/S1470-2045(15)70057-4. Epub 2015 May 27.

Reference Type BACKGROUND
PMID: 26065612 (View on PubMed)

Brozova H, Lucas A, Salmaggi A, Vymazal J. COMET: A phase II randomized study of TTFields versus supportive care in non-small cell lung cancer patients with 1-5 brain metastases - initial safety results. Neuro Oncol. 2015 Nov; 17 (suppl 5): v46. doi:10.1093/neuonc/nov208.6

Reference Type BACKGROUND

Other Identifiers

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EF-25 METIS

Identifier Type: -

Identifier Source: org_study_id

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