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Brief Title: 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).
Official Title: 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).
Study ID: NCT02831959
Brief 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
Grandview Medical Center - Cancer Center, Birmingham, Alabama, United States
Infirmary Cancer Care, Mobile, Alabama, United States
Barrow Neurological Institute, Phoenix, Arizona, United States
Mayo Clinic Phoenix, Phoenix, Arizona, United States
MemorialCare Cancer Institute, Long Beach, California, United States
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange, Orange, California, United States
Kaiser Permanente Redwood City, Redwood City, California, United States
Dignity Health - Mercy Cancer Centers, Sacramento, California, United States
Kaiser Permanente - Sacramento, Sacramento, California, United States
Sharp HealthCare, San Diego, California, United States
University of California, San Francisco, California, United States
St. Mary's Medical Center - Grand Junction, Grand Junction, Colorado, United States
Banner North Colorado Medical Center (NCMC) - Oncology - Greeley, Greeley, Colorado, United States
Banner MD Anderson Cancer Center - McKee Medical Center, Loveland, Colorado, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
UF Health Jacksonville, Jacksonville, Florida, United States
Mayo Clinic, Jacksonville, Florida, United States
Miami Cancer Institute, Miami, Florida, United States
Adult Oncology Research, Orlando, Florida, United States
UF Health Cancer Center, Orlando, Florida, United States
BRCR Medical Center INC, Plantation, Florida, United States
Piedmont Brain Tumor Center, Atlanta, Georgia, United States
Memorial Health University Medical Center, Savannah, Georgia, United States
CDH-Delnor Health System, Warrenville, Illinois, United States
University of Kansas Cancer Center and Medical Pavilion, Kansas City, Kansas, United States
University of Kentucky HealthCare, Lexington, Kentucky, United States
University of Louisville-James Graham Brown Cancer Center, Louisville, Kentucky, United States
Ochsner Health System, New Orleans, Louisiana, United States
Willis-Knighton Cancer Center, Shreveport, Louisiana, United States
University of Maryland, Baltimore, Maryland, United States
Walter Reed National Military Medical Center, Bethesda, Maryland, United States
Tufts Medical Center, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Abbott Northwestern Hospital - Givens Brain Tumor Center, Minneapolis, Minnesota, United States
John Nasseff Neuroscience Institute ANW Brain Tumor Center, Minneapolis, Minnesota, United States
University of Minnesota Medical Center (UMMC) - Fairview - Masonic Cancer Clinic, Minneapolis, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Ellis Fischel Cancer Center, University of Missouri Healthcare, Columbia, Missouri, United States
Oncology Research | Mercy Research, Saint Louis, Missouri, United States
Renown Regional Medical Center, Reno, Nevada, United States
MD Anderson Cancer Center at Cooper, Camden, New Jersey, United States
UNC - Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Vidant Medical Center, Greenville, North Carolina, United States
Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Providence St. Vincent Medical Center, Portland, Oregon, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Medical University of South Carolina- Hollings Cancer Center, Charleston, South Carolina, United States
Prisma Health - Upstate, Greenville, South Carolina, United States
Erlanger Baroness Hospital, Chattanooga, Tennessee, United States
West Cancer Center, Germantown, Tennessee, United States
Mischer Neuroscience Associates - Texas Medical Center, Houston, Texas, United States
Houston Methodist Hospital, Houston, Texas, United States
Texas Oncology, McKinney, Texas, United States
Texas Oncology, Plano, Texas, United States
Baylor Scott & White Medical Center - Temple, Waco, Texas, United States
University of Washington Medical Center, Seattle, Washington, United States
Aurora Research Institute, Milwaukee, Wisconsin, United States
Medizinische Universität Innsbruck, Innsbruck, , Austria
UMHAT Sv. Ivan Rilski EAD, Department of Medical Oncology, Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment Sofiamed, Department of Medical Oncology, Sofia, , Bulgaria
Cancercare Manitoba, Winnipeg, Manitoba, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM), Montreal, Quebec, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Le CIUSSS de I'Est-de-L'ile de Montreal - Hôpital Maisonneuve Rosemont, Montréal, Quebec, Canada
(CHUS) Centre Hospitalier Universitaire de Sherbrooke, Service de Neurochirurgie, Sherbrooke, Quebec, Canada
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Chaoyang, China
The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, Guangdong, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, China
Liaoning Cancer Hospital, Shenyang, Liaoning, China
First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
Qilu Hospital of Shandong University, Jinan, Shandong, China
Shandong Cancer Hospital, Jinan, Shandong, China
Qingdao Central Hospital, Qingdao, Shandong, China
Zigong Fourth People's Hospital, Zigong, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
Fudan University Shanghai Cancer Center, Shanghai, Xuhui District, China
Taizhou Hospital, Zhejiang Province, Zhejiang, Zhejiang, China
Peking University Third Hospital, Beijing, , China
The First Hospital of Jilin University, Changchun, , China
The Second Affiliated Hospital Of Xingtai Medical College, Hebei, , China
The First Hospital of China Medical University, Shenyang, , China
The University of Hong Kong-Shenzhen Hospital, Shenzhen, , China
The First Affiliated Hospital of Xiamen University, Xiamen, , China
Radiochirugia Zagreb, Sveta Nedelja, , Croatia
University Hospital Lille, Lille, , France
Clairval Hospital Center, Marseille, , France
Hopital Pitié-Salpétriere, Paris, , France
Centre Hospitalier Universitaire de Saint-Étienne, Saint-Étienne, , France
Klinik für Radioonkologie und Strahlentherapie der Charité Universitätsmedizin Berlin Campus Charité Virchow-Klinikum, Berlin, , Germany
Universitätsklinikum Düsseldorf, Düsseldorf, , Germany
Dr. Senckenbergisches Institut for Neurooncology,, Frankfurt am Main, , Germany
Dr. Senckenbergisches Institut für Neuroonkologie, Zentrum der Neurologie und Neurochirurgie, Frankfurt am main, , Germany
Universitätsklinikum Halle (Saale), Klinik für Innere Medizin IV, Hämatologie / Onkologie, Halle (Saale), , Germany
Heidelberg University Clinic for Radiooncology and Radiation Therapy, Heidelberg, , Germany
Queen Mary Hospital, Hong Kong, , Hong Kong
National Koranyi Institute of Tb and Pulmonology, Budapest, , Hungary
Onkologiai Osztaly, Balassa Janos Korhaz, Szekszárd, , Hungary
Geza Hetenyi Hospital-Clinic of Jasz-Nagykun-Szolnok County, Szolnok, , Hungary
Rambam Medical Center, Haifa, , Israel
Hadassah Medical Organization, Jerusalem, , Israel
Rabin Medical Center, Petah Tikva, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Sourasky Medical Center, Tel Aviv, , Israel
A.O.S.G. Moscati Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità, Avellino, , Italy
General Hospital Gavazzeni, Bergamo, , Italy
Radioterapia Oncologica AOU Careggi, Firenze, , Italy
Azienda Socio Sanitaria Territoriale di Lecco, Lecco, , Italy
University Hospital of Messina AOU Policlinico "G. Martino", Messina, , Italy
The IRCCS Carlo Besta Neurological Institute Foundation, Milan, , Italy
A.O.U Città della Salute e della Scienza di Torino, Torino, , Italy
Marek Harat Private Practice, Neurosurgery and Radiation Oncology, Bydgoszcz, , Poland
University Clinical Center, Gdańsk, , Poland
Maria Sklodowska-Curie National Research Institute of Oncology, Gliwice, , Poland
MS Clinsearch Sp. z.o.o., Lublin, , Poland
Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Poznań, , Poland
Gamma Knife Center Warsaw, Warsaw, , Poland
Center for Neuro-oncology, Neurosurgery Clinic, Clinical Center of Serbia, Belgrad, , Serbia
Catalan Institute of Oncology, Barcelona, , Spain
Hospital Universitario HM Sanchinarro Edificio CIOCC, Madrid, , Spain
Clinica Universidad de Navarra, Pamplona, , Spain
Name: Minesh Mehta, MD
Affiliation: Miami Cancer Institute, Miami FL USA
Role: PRINCIPAL_INVESTIGATOR
Name: Paul Brown, MD
Affiliation: MD Anderson Cancer Center, Houston TX USA
Role: PRINCIPAL_INVESTIGATOR
Name: Vinai Gondi, MD
Affiliation: Northwestern Medicine Cancer Center, Warenville IL USA
Role: PRINCIPAL_INVESTIGATOR
Name: Manmeet Ahluwalia, MD
Affiliation: Cleveland Clinic, Cleveland OH USA
Role: PRINCIPAL_INVESTIGATOR