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Spots Global Cancer Trial Database for 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).

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

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