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).

Who is this study for? Adult patients with Non-Small Cell Lung Cancer and Brain Tumors
What treatments are being studied? NovoTTF-100M
Status: Recruiting
Location: See all (110) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

⁃ 18 years of age and older

⁃ Life expectancy of ≥ 3 months

⁃ 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).

• 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.

• 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)

Locations
United States
Alabama
Grandview Medical Center - Cancer Center
Recruiting
Birmingham
University of Alabama at Birmingham Comprehensive Cancer Center
Recruiting
Birmingham
Arizona
Barrow Neurological Institute
Recruiting
Phoenix
Mayo Clinic Phoenix
Recruiting
Phoenix
California
MemorialCare Cancer Institute
Recruiting
Long Beach
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
Recruiting
Orange
Kaiser Permanente Redwood City
Recruiting
Redwood City
Dignity Health - Mercy Cancer Centers
Recruiting
Sacramento
Kaiser Permanente - Sacramento
Recruiting
Sacramento
Sharp HealthCare
Recruiting
San Diego
University of California
Recruiting
San Francisco
Florida
Mayo Clinic
Recruiting
Jacksonville
Miami Cancer Institute
Recruiting
Miami
Adult Oncology Research
Recruiting
Orlando
UF Health Cancer Center
Recruiting
Orlando
BRCR Medical Center INC
Recruiting
Plantation
Georgia
Piedmont Brain Tumor Center
Recruiting
Atlanta
Memorial Health University Medical Center
Recruiting
Savannah
Illinois
CDH-Delnor Health System
Recruiting
Warrenville
Kentucky
University of Louisville-James Graham Brown Cancer Center
Recruiting
Louisville
Louisiana
Ochsner Health System
Recruiting
New Orleans
Willis-Knighton Cancer Center
Recruiting
Shreveport
Massachusetts
Beth Israel Deaconess Medical Center
Recruiting
Boston
Tufts Medical Center
Recruiting
Boston
Maryland
University of Maryland
Recruiting
Baltimore
Walter Reed National Military Medical Center
Recruiting
Bethesda
Michigan
Karmanos Cancer Institute
Recruiting
Detroit
Minnesota
Abbott Northwestern Hospital - Givens Brain Tumor Center
Recruiting
Minneapolis
John Nasseff Neuroscience Institute ANW Brain Tumor Center
Recruiting
Minneapolis
University of Minnesota Medical Center (UMMC) - Fairview - Masonic Cancer Clinic
Recruiting
Minneapolis
Missouri
Ellis Fischel Cancer Center, University of Missouri Healthcare
Recruiting
Columbia
Oncology Research | Mercy Research
Recruiting
Saint Louis
Mississippi
University of Mississippi Medical Center
Recruiting
Jackson
North Carolina
UNC - Lineberger Comprehensive Cancer Center
Recruiting
Chapel Hill
Vidant Medical Center
Recruiting
Greenville
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
Recruiting
Winston-salem
New Jersey
MD Anderson Cancer Center at Cooper
Recruiting
Camden
Nevada
Renown Regional Medical Center
Recruiting
Reno
Ohio
Cleveland Clinic
Recruiting
Cleveland
Oregon
Providence St. Vincent Medical Center
Recruiting
Portland
Pennsylvania
Geisinger Medical Center
Recruiting
Danville
Rhode Island
Rhode Island Hospital
Recruiting
Providence
South Carolina
Medical University of South Carolina- Hollings Cancer Center
Recruiting
Charleston
Tennessee
Erlanger Baroness Hospital
Recruiting
Chattanooga
West Cancer Center
Recruiting
Germantown
Texas
Houston Methodist Hospital
Recruiting
Houston
Mischer Neuroscience Associates - Texas Medical Center
Enrolling by invitation
Houston
Texas Oncology
Recruiting
Mckinney
Texas Oncology
Recruiting
Plano
Baylor Scott & White Medical Center - Temple
Enrolling by invitation
Waco
Washington
University of Washington Medical Center
Recruiting
Seattle
Wisconsin
Aurora Research Institute
Recruiting
Milwaukee
Other Locations
Austria
Medizinische Universität Innsbruck
Recruiting
Innsbruck
Bulgaria
UMHAT Sv. Ivan Rilski EAD, Department of Medical Oncology
Recruiting
Sofia
University Multiprofile Hospital for Active Treatment Sofiamed, Department of Medical Oncology
Recruiting
Sofia
Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Recruiting
Montreal
Jewish General Hospital
Recruiting
Montreal
Le CIUSSS de I'Est-de-L'ile de Montreal - Hôpital Maisonneuve Rosemont
Recruiting
Montréal
(CHUS) Centre Hospitalier Universitaire de Sherbrooke, Service de Neurochirurgie
Completed
Sherbrooke
Cancercare Manitoba
Recruiting
Winnipeg
China
Cancer Hospital Chinese Academy of Medical Sciences
Recruiting
Beijing
Peking University Third Hospital
Recruiting
Beijing
The First Hospital of Jilin University
Recruiting
Changchun
The First Affiliated Hospital of Guangdong Pharmaceutical University
Recruiting
Guangzhou
The Second Affiliated Hospital Of Xingtai Medical College
Recruiting
Hebei
Qilu Hospital of Shandong University
Recruiting
Jinan
Shandong Cancer Hospital
Recruiting
Jinan
Nanjing Drum Tower Hospital
Recruiting
Nanjing
Qingdao Central Hospital
Recruiting
Qingdao
Fudan University Shanghai Cancer Center
Recruiting
Shanghai
Liaoning Cancer Hospital
Recruiting
Shenyang
The First Hospital of China Medical University
Recruiting
Shenyang
The University of Hong Kong-Shenzhen Hospital
Recruiting
Shenzhen
The First Affiliated Hospital of Soochow University
Recruiting
Suzhou
Tianjin Medical University Cancer Institute and Hospital
Recruiting
Tianjin
Hubei Cancer Hospital
Recruiting
Wuhan
Zhongnan Hospital of Wuhan University
Recruiting
Wuhan
First Affiliated Hospital of Xi'an Jiaotong University
Recruiting
Xi'an
The First Affiliated Hospital of Xiamen University
Recruiting
Xiamen
Northern Jiangsu People's Hospital
Recruiting
Yangzhou
Taizhou Hospital, Zhejiang Province
Recruiting
Zhejiang
Zigong Fourth People's Hospital
Recruiting
Zigong
Croatia
Radiochirugia Zagreb
Recruiting
Sveta Nedelja
France
University Hospital Lille
Recruiting
Lille
Clairval Hospital Center
Not yet recruiting
Marseille
Hopital Pitié-Salpétriere
Recruiting
Paris
Germany
Klinik für Radioonkologie und Strahlentherapie der Charité Universitätsmedizin Berlin Campus Charité Virchow-Klinikum
Recruiting
Berlin
Universitätsklinikum Düsseldorf
Recruiting
Düsseldorf
Dr. Senckenbergisches Institut für Neuroonkologie, Zentrum der Neurologie und Neurochirurgie
Recruiting
Frankfurt Am Main
Universitätsklinikum Halle (Saale), Klinik für Innere Medizin IV, Hämatologie / Onkologie
Recruiting
Halle (saale)
Hong Kong Special Administrative Region
Queen Mary Hospital
Recruiting
Hong Kong
Hungary
National Koranyi Institute of Tb and Pulmonology
Recruiting
Budapest
Onkologiai Osztaly, Balassa Janos Korhaz
Recruiting
Szekszárd
Geza Hetenyi Hospital-Clinic of Jasz-Nagykun-Szolnok County
Recruiting
Szolnok
Israel
Rambam Medical Center
Recruiting
Haifa
Hadassah Medical Organization
Recruiting
Jerusalem
Rabin Medical Center
Recruiting
Petah Tikva
Sheba Medical Center
Recruiting
Ramat Gan
Sourasky Medical Center
Recruiting
Tel Aviv
Italy
A.O.S.G. Moscati Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità
Completed
Avellino
Azienda Socio Sanitaria Territoriale di Lecco
Recruiting
Lecco
University Hospital of Messina AOU Policlinico G. Martino
Recruiting
Messina
The IRCCS Carlo Besta Neurological Institute Foundation
Recruiting
Milan
A.O.U Città della Salute e della Scienza di Torino
Not yet recruiting
Torino
Poland
Marek Harat Private Practice, Neurosurgery and Radiation Oncology
Recruiting
Bydgoszcz
University Clinical Center
Recruiting
Gdańsk
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Recruiting
Poznań
Serbia
Center for Neuro-oncology, Neurosurgery Clinic, Clinical Center of Serbia
Recruiting
Belgrad
Spain
Catalan Institute of Oncology
Recruiting
Barcelona
Clinica Universidad de Navarra
Recruiting
Pamplona
Contact Information
Primary
Teresa Bagulho
clinicaltrials@novocure.com
+1.603.206.2337
Backup
Tijy John
clinicaltrials@novocure.com
1.603.206.2337
Time Frame
Start Date: July 2016
Estimated Completion Date: September 2022
Participants
Target number of participants: 270
Treatments
Experimental: 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.
Active Comparator: 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.
Authors
Cesaer Guida, Scott Gatson, Anna Maria Lucas, Melissa Lemieux, Vito John Antonucci, aronp@clalit.org.il aronp@clalit.org.il, Antonio Antonio, Alfred Attia, Deborah Deborah, Teri Kreisl, Nicholas Blondin, Ronald Scheff, Deepa Subramaniam, Jennifer De Los Santos, Paul Anderson, Jose Carrillo, Vinai Gondi, Gregory Kubicek, Matthew Ballo, Adam Nowlan, Nati Lerman, Vijay Kudithipudi, Brett Theeler, Lars Anker, THOMAS DEVLIN, Linda Chan, Jennifer Tseng, Mark Shahin, Ekokobe Fonkem, Kendra Harris, Jennifer Connelly, Michael Hasselle, Martin Voss, Marcus Ware, Simon Khagi, David Tran, Scott Peak, Anand Shivnani, Minesh Mehta, Stephanie Weiss, Herbert Newton, George Bobustuc, Michael Dominello, Steve Braunstein, John Trusheim, Stephen Karlovits, Goetz Kloecker, Steven Brem, Wylie Zhu, Daniel Trifiletti, Alexander Mohler, Venita Williams, Priya Kumthekar, Manmeet Ahluwalia, Hani Babiker, Morris Groves, Lynne Taylor, Bernard Taylor, Steven DiBiase, Mark Anderson, Abhishek Solanki, Yolanda Garces, Heinrich Elinzano, Jethro Hu, Garrett Green, Enrico Lallana, Siavash Jabbari, Isabelle Germano, Paul Brown, Scott Lindhorst, Emil Lou, Eric Wong, Steven Toms, Rimas Lukas, Suriya Jeyapalan, Scott Turner, Jeffrey Craft, Thomas Chen, Robert Albright, Clinton Leinweber, Jing Li, Mark Mishra, Daniel Ma, John Fiveash, Ricky Chen, Eric Burton, Amir Azadi, Orit Kaidar-Person, Jason Tache, James Petrikas, Gregory Biedermann, Chiachien Jake Wang, Norleena P. Gullett, Yi Wang, Ewa Szutowicz-Zielińska, Pierre Chabot, Loïc Feuvret, Jörn Rüssel, Philippe Metellus, Emilie Le Rhun, Marta Moreno, Ana Mišir Krpan, Margarita Taushanova-Hadzhieva, K. Stuart Lee, Ivo Tremont, Saranya Kakumanu, Lijun Wang, Hongquing Zhuang, Jidong Miao, Dr. Zhang, Hong Yu, Dongquing LV, Thierry Muanza, Tai-Chung Lam, Xiaotao Zhang, Alexander Lossos, Naren Ramakrishna, Songbing Qin, Rodryg Ramlau, Terence Sio, Maciej Harat, Michael Sabel, Xicheng Wang, Jinming Yu, Bozhil Robev, Zhengfei Zhu, Jay-Jiguang Zhu, Lihua Dong, Giovanna Paola Bellotti, Gregory Biedermnann, Michael Chan, David Mathieu, Jason Sheehan, Nina Martinez, Desheng Hu, Leor Zach, Zhouguang Hui, Buhai Wang, Christian Freyschlag, Guang Li, David Roberge, Lujun Zhao, Yufeng Cheng, Brian Yaremko, Qi Zhao, Christopher Dardis, Antonio Silvani, Danica Grujicic, Mario Airoldi, Qin Lin, Federica Grosso, Andrea Salmaggi, Conghua Conghua Xie, Tibor Csőszi, Li Yang, Jing Yan
Sponsors
Leads: NovoCure GmbH

This content was sourced from clinicaltrials.gov

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