Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3)

• Sponsor: NovoCure Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03377491
• Collaborator: (none)
• Enrollment: 556
• Locations: 151
• Arms: 2
• Anticipated Duration (Months): 76.7
• Patients Per Site: 3.7
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

Brief Summary:

The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic adenocarcinoma.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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Adenocarcinoma	Device: NovoTTF-100L(P); Drug: Gemcitabine; Drug: nab paclitaxel	Phase 3

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 pancreatic adenocarcinoma pre-clinical models both as a single modality treatment and in combination with chemotherapies. TTFields have been demonstrated to act synergistically with taxanes and have been shown to be additive when combined with other chemotherapies including gemcitabine. In addition, TTFields have shown to inhibit metastatic spread of malignant melanoma in in vivo experiment.

In a pilot study, 40 patients with locally advanced or metastatic pancreatic adenocarcinoma received gemcitabine together with TTFields (150 kHz) or gemcitabine and nab-paclitaxel together with TTFields (150 kHz) applied to the abdomen until disease progression. The combination was well tolerated and the only device-related adverse event was contact dermatitis.

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 2017).

DESCRIPTION OF THE TRIAL:

All patients included in this trial are patients with locally advanced pancreatic adenocarcinoma. In addition, all patients must meet all eligibility criteria.

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

1. Patients receive gemcitabine and nab-paclitaxel in combination with TTFields using the NovoTTF-100L(P) System.

2. Patients receive gemcitabine and nab-paclitaxel without TTFields.

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-100L(P) group, the patients will be treated continuously with the device until progression in the abdomen. On both arms, patients who have progression outside the abdomen will switch to a second line treatment according to local practice.

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 pancreatic adenocarcinoma with very few side effects.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 556 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Gemcitabine and Nab-paclitaxel for Front-line Treatment of Locally-advanced Pancreatic Adenocarcinoma
• Actual Study Start Date: May 10, 2018
• Anticipated Primary Completion Date: Sep 30, 2024
• Anticipated Study Completion Date: Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NovoTTF-100L(P) Patients receive TTFields using the NovoTTF-100L(P) System together with gemcitabine and nab-Paclitaxel	Device: NovoTTF-100L(P); Patients receive continuous TTFields treatment using the NovoTTF-100L(P) device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the torso. The treatment enables the patient to maintain regular daily routine.; Other Names: TTFields ; Drug: Gemcitabine; Gemcitabine 1000 mg/m^2 over 30 minute infusion will be administered immediately after nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle.; Drug: nab paclitaxel; nab-paclitaxel 125 mg/m^2 administered as an intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle.
Active Comparator: Best Standard of Care Patients receive best standard of care with gemcitabine and nab-Paclitaxel	Drug: Gemcitabine; Gemcitabine 1000 mg/m^2 over 30 minute infusion will be administered immediately after nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle.; Drug: nab paclitaxel; nab-paclitaxel 125 mg/m^2 administered as an intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle.

Outcome Measures

Primary Outcome Measures

1. Overall survival [4 years]

Secondary Outcome Measures

1. Progression-free survival [4 years]

2. Local progression-free survival [4 years]

3. Objective response rate [4 years]

4. One-year survival rate [4 years]

5. Quality of life [4 years]

   Quality of life will be assessed using the EORTC QLQ C-30 questionnaire with EORTC QLQ-PAN26 (Pancreatic Cancer symptom) supplement.

6. Pain-free survival [4 years]

   Pain-free survival will measured as the duration between the time of randomization until a greater than or equal to two-point decline from a baseline measurement in a patient self-reported visual analogue scale (VAS) is recorded or death, whichever occurs first.

7. Puncture-free survival [4 years]

8. Resectability rate [4 years]

9. Toxicity profile [4 years]

   Toxicity profile in patients treated with TTFields in combination with gemcitabine and nab-paclitaxel compared to the toxicity profile of patients treated with chemotherapy alone, measured by the rate of treatment-emergent toxicities in both arms. Adverse events will be collected and recorded based on the revised Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 18 years of age and older

2. Life expectancy of ≥ 3 months

3. Histological/cytological diagnosis of de novo adenocarcinoma of the pancreas

4. Unresectable, locally advanced stage disease according to the following criteria:

• Head/uncinate process:

1. Solid tumor contact with SMA>180°

2. Solid tumor contact with the CA>180°

3. Solid tumor contact with the first jejunal SMA branch

4. Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t tumor or bland thrombus)

5. Contact with most proximal draining jejunal branch into SMV

• Body and tail

1. Solid tumor contact of >180° with the SMA or CA

2. Solid tumor contact with the CA and aortic involvement

3. Unreconstructible SMV/PV due to tumor involvement or occlusion (can be d/t tumor or bland thrombus)

• No distant metastasis, including non-regional lymph node metastasis

• No borderline resectable (per Al-Hawary MM, et al., Radiology 201414)

1. ECOG score 0-2

2. Amenable and assigned by the investigator to receive therapy with gemcitabine and nab-paclitaxel

3. Able to operate the NovoTTF-100L(P) System independently or with the help of a caregiver

4. Signed informed consent form for the study protocol

Exclusion Criteria:

1. Prior palliative treatment (e.g. surgery, radiation) to the tumor

2. Cancer requiring anti-tumor treatment within the 5 years before inclusion, excluding treated stage I prostate cancer, in situ cervical or uterus cancer, in situ breast cancer and non-melanomatous skin cancer.

3. Serious co-morbidities:

4. Clinically significant (as determined by the investigator) hematological, hepatic and renal dysfunction, 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); AST and/or ALT > 2.5 x ULN; and serum creatinine > 1.5 x ULN.

5. 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).

6. 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 trial.

7. History of cerebrovascular accident (CVA) within 6 months prior to randomization or that is not stable.

8. Active infection or serious underlying medical condition that would impair the ability of the patient to receive protocol therapy.

9. 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. Concurrent anti-tumor therapy beyond gemcitabine and nab-paclitaxel

11. Implantable electronic medical devices in the torso, such as pacemakers

12. Known severe hypersensitivities to medical adhesives or hydrogel, or to one of the chemotherapies used in this trial.

13. Pregnancy or breast-feeding (female patients with reproductive potential and their partners must accept to use effective contraception throughout the entire study period and for 3 months after the end of treatment). All patients who are capable of becoming pregnant must take a pregnancy test which is negative within 72 hours before beginning treatment. The definition of effective contraception is left up to the decision of the investigator.

14. Unable to follow the protocol for medical, psychological, familial, geographic or other reasons.

15. Admitted to an institution by administrative or court order.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grandview Medical Center, Cancer Center	Birmingham	Alabama	United States	35243
2	Infirmary Cancer Care	Mobile	Alabama	United States	36607
3	Banner MD Anderson Cancer Center	Gilbert	Arizona	United States	85234
4	Arizona Oncology Associates, PC- HOPE - US Oncology Research	Tucson	Arizona	United States	85711
5	University of Arizona Cancer Center	Tucson	Arizona	United States	85724-5024
6	Pacific Cancer Medical Center	Anaheim	California	United States	92801
7	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
8	Dignity Health - Mercy Cancer Centers	Sacramento	California	United States	95816
9	Sutter Cancer Center Sacramento	Sacramento	California	United States	95816
10	Boca Raton Regional Hospital, Lynn Cancer Institute	Boca Raton	Florida	United States	33486
11	Mayo Clinic Hospital - Florida	Jacksonville	Florida	United States	32224
12	Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
13	AdventHealth Neuro Oncology	Orlando	Florida	United States	32804
14	BRCR Medical Center INC	Plantation	Florida	United States	33324
15	Florida Cancer Specialists	Saint Petersburg	Florida	United States	33705
16	Florida Hospital Tampa	Tampa	Florida	United States	33613
17	Piedmont Cancer Institute	Atlanta	Georgia	United States	30318
18	Illinois Cancer Specialist - US Oncology Research	Arlington Heights	Illinois	United States	60005
19	Rush University Medical Center	Chicago	Illinois	United States	60612
20	Loyola University Medical Center	Maywood	Illinois	United States	60153
21	University of Kansas Medical Cancer Center	Fairway	Kansas	United States	66205
22	Norton Cancer Institute, Norton Healthcare Pavilion	Louisville	Kentucky	United States	40202
23	Ochsner Medical Center	New Orleans	Louisiana	United States	70121
24	Central Maine Medical Center, Clinical Research Department	Lewiston	Maine	United States	04240
25	University of Maryland Comprehensive Cancer Center	Baltimore	Maryland	United States	21201
26	Maryland Oncology Hematology, P.A - US Oncology Research	Columbia	Maryland	United States	21044
27	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
28	UMass Memorial Medical Center	Worcester	Massachusetts	United States	01605
29	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
30	Cancer and Hematology Centers of Western Michigan, PC	Grand Rapids	Michigan	United States	49503
31	University of Minnesota	Minneapolis	Minnesota	United States	55455
32	MidAmerica Division	Kansas City	Missouri	United States	64132
33	Nebraska Methodist Hospital	Omaha	Nebraska	United States	68114
34	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89619
35	Astera Cancer Care	East Brunswick	New Jersey	United States	08816
36	Kaleida Health	Buffalo	New York	United States	14210
37	Bassett Medical Center	Cooperstown	New York	United States	13326
38	NYU Langone Arena Oncology	Lake Success	New York	United States	11042
39	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
40	Willamette Valley Cancer Institute and Research Center - US Oncology Research	Eugene	Oregon	United States	97401
41	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
42	Vita Medical Associates, P.C.	Fountain Hill	Pennsylvania	United States	18015
43	UT/Erlanger Oncology & Hematology	Chattanooga	Tennessee	United States	37403
44	Tennessee Cancer Specialists	Knoxville	Tennessee	United States	37909-1327
45	Tennessee Oncology	Nashville	Tennessee	United States	37203
46	Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center - US Oncology Research	Beaumont	Texas	United States	77702
47	Texas Oncology - Bedford - US Oncology Reasearch	Bedford	Texas	United States	76022
48	Methodist Regional Cancer Center	Dallas	Texas	United States	75203
49	Texas Oncology - Baylor - US Oncology Research	Dallas	Texas	United States	75246
50	Texas Oncology - El Paso Cancer Treatment Center Gateway - US Oncology Research	El Paso	Texas	United States	79915
51	Houston Methodist Cancer Center	Houston	Texas	United States	77030
52	Baylor Scott and White Medical Center	Temple	Texas	United States	76508
53	Texas Oncology - Tyler - US Oncology Research	Tyler	Texas	United States	75702
54	Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - US Oncology Research	Roanoke	Virginia	United States	24014
55	Vista Oncology Inc PS	Olympia	Washington	United States	98506
56	Virginia Mason Medical Center	Seattle	Washington	United States	98101
57	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109
58	West Virginia University Cancer Institute	Morgantown	West Virginia	United States	26506
59	Greenslopes Private Hospital	Greenslopes	Queensland	Australia	4120
60	St. John of God Murdoch Hospital	Murdoch	Western Australia	Australia	6150
61	Sydney Adventist Hospital	Wahroonga		Australia	NSW 2076
62	Westmead Hosptial	Westmead		Australia	NSW 2145
63	Klinikum Klagenfurt am Wörthersee	Klagenfurt	Wörthersee	Austria	9020
64	Medical University Graz	Graz		Austria	17070
65	Univ. Klinik für Innere Medizin III der PMU	Salzburg		Austria	5020
66	Landes-Krankenhaus Steyr	Steyr		Austria	4400
67	UZ Leuven	Leuven		Belgium	3000
68	Centro de Pesquisa Clínica e Ensino Florianópolis LTDA	Florianópolis		Brazil
69	Irmandade da Santa Casa de Misericórdia de Porto Alegre	Porto Alegre		Brazil	90020-090
70	IRPCc - Instituto Ribeirãopretano de Combate ao Câncer	Ribeirão Preto		Brazil	14015-130
71	Oncoclinicas Group Botafogo	Rio De Janeiro		Brazil	22250-040
72	Núcleo de Pesquisa Clínica da Rede São Camilo	São Paulo		Brazil	04014-002
73	London Regional Cancer Program, London Health Sciences Centre	London	Ontario	Canada	N6A 5W9
74	Centre Hospitalier de I'Universitaire de de Montreal (CHUM)	Montréal	Quebec	Canada	H2X 3E4
75	Centre Hospitalier Universitaire de Sherbrooke CIUSSS de l'Estrie - CHUS	Sherbrooke	Quebec	Canada	J1G 1B1
76	Sun Yat-sen Memorial Hospital Sun Yat-sen University	Guangzhou	Guangdong	China	510000
77	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang	China	150086
78	Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei	China	430000
79	Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei	China	430014
80	The First Affiliated Hospital of Xi 'an Jiaotong University	Xi'an	Shaanxi	China	710061
81	Linyi Cancer Hospital	Linyi	Shandong	China	276000
82	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China
83	Beijing Cancer Hospital	Beijing		China	100142
84	The first hospital of Jilin University	Changchun		China	130021
85	Guangdong provincial people's hospital	Guangzhou		China	510000
86	Jilin Guowen Hospital	Jilin		China	136100
87	Shanghai Changhai Hospital	Shanghai		China	200433
88	Shanxi Provincial Cancer Hospital	Shanxi		China	030013
89	Xingtai People's Hospital	Xingtai		China
90	The First Affiliated Hospital of Zhengzhou University	Zhengzhou		China	450052
91	Henan Provincial Peoples Hospital	Zhengzhou		China
92	University Hospital Centre Zagreb	Zagreb		Croatia	10000
93	Nemocnice Nový Jičín	Nový Jičín		Czechia	741 01
94	University Hospital Olomouc	Olomouc		Czechia	779 00
95	General University Hospital in Prague	Praha 2		Czechia	128 08
96	Nemocnice Na Bulovce	Praha 8		Czechia	180 81
97	Hopital haut-Léveque CHU Bordeaux - Service d'Hépato- Gastroentérologie et d'Oncologie digestive	Pessac	Bordeaux	France	33604
98	Institut de Cancérologie de l'Ouest	Angers cedex		France	49055
99	Centre Hospitalier de Bretagne Sud /Site du Scorff	Lorient		France	56322
100	Centre Léon Bérard	Lyon		France
101	Service d'Oncologie médicale du Pr. Andre, Hôpital Saint-Antoine	Paris		France	75012
102	Hôpital Privé des Côtes d'Armor	Plérin		France	22190
103	Centre de Lutte Contre le Cancer (CLCC) - Centre Paul Strauss	Strasbourg		France	67000
104	Clinique Sainte Anne - Groupe Hospitalier Saint-Vincent, Strasbourg Oncologie Libérale	Strasbourg		France	67000
105	Klinikum Chemnitz gGmbH	Chemnitz		Germany	09116
106	VK und K Studien GbR Landshut-Achdorf	Landshut		Germany	84036
107	Bonifatius Hospital Hematology and Oncology	Lingen		Germany	49808
108	Carl-von-Basedow-klinikum Saalekrei	Merseburg		Germany	06217
109	Klinikum München Bogenhausen, Klinik für Gastroenterologie und Gastroenterologische Onkologie	München		Germany	81925
110	Universitätsklinikum Ulm	Ulm		Germany	D-89081
111	Queen Mary Hospital	Hong Kong		Hong Kong
112	National Institute of Oncology	Budapest		Hungary	1122
113	Bekes County Hospital	Gyula		Hungary	5700
114	Bacs-Kiskun County Hospital	Kecskemét		Hungary	6000
115	Tolna County Hospital	Szekszárd		Hungary	7100
116	Jasz-Nagykun-Szolnok County Hospital	Szolnok		Hungary	5000
117	Rambam Health Care Campus, Oncology Institute	Haifa		Israel	3109601
118	Sourasky Medical Center, Oncology Department	Tel Aviv		Israel	64239
119	A.O. SS Antonio e Biagio e Cesare Arrigo	Alessandria		Italy	15121
120	Università Campus Bio-Medico di Rome	Roma		Italy	00128
121	A.O.U Città della Salute e della Scienza di Torino	Torino		Italy	10126
122	Dong-A University Hospital	Seogu	Busan	Korea, Republic of
123	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	13620
124	Keimyung University, Dongsan hospital	Daegu		Korea, Republic of	42601
125	Inha University Hospital	Incheon		Korea, Republic of	22332
126	CHA Bundang Medical Center	Seongnam-si		Korea, Republic of
127	Samsung Medical Center	Seoul		Korea, Republic of	06351
128	Mediadvance Clinical	Chihuahua	Chih.	Mexico	31210
129	Accelerium S de RL de C.V.	Monterrey	NL	Mexico	64000
130	Centro de Estudios de Alta Especialidad de Sinaloa, ubicado	Mazatlán	Sinaloa	Mexico	82110
131	Centro de Investigación Médica Aguascalientes (CIMA),	Aguascalientes		Mexico	20116
132	Clinstile S.A. de C.V.,	Cuauhtémoc		Mexico	06700
133	Centro de Investigación Clínica PCR	Cuautitlán Izcalli		Mexico	54769
134	Clínica Integral Internacional de Oncología, S de RL de CV	Puebla		Mexico	72530
135	Centro Potosino de Investigación Médica SC,	San Luis Potosí		Mexico	78250
136	Centro Hemato-Oncologico Privado CHOP	Toluca de Lerdo		Mexico	50080
137	Phylasis Clinicas Research S.de R.L. de C.V. (PCR)-Toluca	Toluca De Lerdo		Mexico	50180
138	Oncology Clinic Clinical Hospital of Przemienienia Pańskiego UM in Poznaniu	Poznań		Poland	60-596
139	Centrum Medyczne MrukMed	Rzeszów		Poland	35-021
140	Oncology and Radiotherapy Clinic, Oncology Center - Institute	Warsaw		Poland	02-034
141	Jan Mikulicz-Radecki University Teaching Hospital	Wrocław		Poland	50-556
142	Instituto Oncòlogico Dr. Rosell	Barcelona		Spain	08028
143	Vall d´Hebron University Hospital	Barcelona		Spain
144	Hospital General Universitario de Elche	Elche		Spain
145	HM Hospitales - Centro Integral Oncologico Clara Campal - CIOCC	Madrid		Spain	28050
146	Hospital Regional Universitario de Málaga	Málaga		Spain	29010
147	Clinica Universiatria de Navarra	Pamplona		Spain	31008
148	Hospital Universitario Marqués de Valdecilla	Santander		Spain
149	Instituto Valenciano de Oncología IVO	Valencia		Spain	46009
150	Hôpital Fribourgeois/Freiburger Spital	Fribourg		Switzerland	1708
151	KS Winterthur	Winterthur		Switzerland	8401

Sponsors and Collaborators

• NovoCure Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Giladi M, Schneiderman RS, Porat Y, Munster M, Itzhaki A, Mordechovich D, Cahal S, Kirson ED, Weinberg U, Palti Y. Mitotic disruption and reduced clonogenicity of pancreatic cancer cells in vitro and in vivo by tumor treating fields. Pancreatology. 2014 Jan-Feb;14(1):54-63. doi: 10.1016/j.pan.2013.11.009. Epub 2013 Dec 4.
• 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.
• Kirson ED, Dbalý 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. Epub 2007 Jun 5.
• 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.
• 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.
• Stupp R, Taillibert S, Kanner A, Read W, Steinberg D, Lhermitte B, Toms S, Idbaih A, Ahluwalia MS, Fink K, Di Meco F, Lieberman F, Zhu JJ, Stragliotto G, Tran D, Brem S, Hottinger A, Kirson ED, Lavy-Shahaf G, Weinberg U, Kim CY, Paek SH, Nicholas G, Bruna J, Hirte H, Weller M, Palti Y, Hegi ME, Ram Z. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2306-2316. doi: 10.1001/jama.2017.18718. Erratum in: JAMA. 2018 May 1;319(17):1824.
• 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.
• Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbalý 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.

• Responsible Party: NovoCure Ltd.
• ClinicalTrials.gov Identifier: NCT03377491
• Other Study ID Numbers: EF-27
• First Posted: Dec 19, 2017
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by NovoCure Ltd.: Locally Advanced Pancreatic Adenocarcinoma; TTFields; Tumor Treating Fields; Gemcitabine; nab-Paclitaxel; Minimal toxicity; TTF; Novocure
• Additional relevant MeSH terms: Adenocarcinoma; Gemcitabine; Paclitaxel

Study Results

No Results Posted as of Aug 24, 2022