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
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Basic Information
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COMPLETED
PHASE3
298 participants
INTERVENTIONAL
2016-07-31
2024-11-29
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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.
NovoTTF-200M device
Best Standard of Care
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.
Best Standard of Care
Interventions
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NovoTTF-200M device
Best Standard of Care
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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NovoCure GmbH
INDUSTRY
Responsible Party
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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
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
St 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
Le CIUSSS de I'Est-de-L'ile de Montreal - Hôpital Maisonneuve Rosemont
Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, 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 Municipality, 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-Etienne, , 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, , 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
Florence, , 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
Gdansk, , 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
Poznan, , Poland
Gamma Knife Center Warsaw
Warsaw, , Poland
Center for Neuro-oncology, Neurosurgery Clinic, Clinical Center of Serbia
Belgrade, , Serbia
Catalan Institute of Oncology
Barcelona, , Spain
Hospital Universitario HM Sanchinarro Edificio CIOCC
Madrid, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Countries
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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
Other Identifiers
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EF-25 METIS
Identifier Type: -
Identifier Source: org_study_id
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