Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

Sponsor

AbbVie (Industry)

Overall Status

Completed

CT.gov ID

NCT02106546

Collaborator

(none)

970

Enrollment

225

Locations

Arms

67.4

Actual Duration (Months)

4.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC).

Condition or Disease	Intervention/Treatment	Phase
Squamous Non-Small Cell Lung Cancer	Drug: Carboplatin Drug: Veliparib Drug: Paclitaxel Drug: Placebo to veliparib	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

970 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Actual Study Start Date :

Apr 10, 2014

Actual Primary Completion Date :

Jan 3, 2017

Actual Study Completion Date :

Nov 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Veliparib + Carboplatin + Paclitaxel Participants received veliparib 120 mg orally twice daily (BID) on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an area under the concentration-time curve (AUC) 6 mg/mL/min and paclitaxel 200 mg/m² by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression.	Drug: Carboplatin Carboplatin administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion. Drug: Veliparib Capsules taken orally twice a day, 12 hours apart. Other Names: ABT-888 Drug: Paclitaxel Paclitaxel administered intravenously over 3 hours at a dose of 200 mg/m².
Placebo Comparator: Placebo + Carboplatin + Paclitaxel Participants received placebo orally BID on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an AUC 6 mg/mL/min and paclitaxel 200 mg/m² by IV infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression.	Drug: Carboplatin Carboplatin administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion. Drug: Paclitaxel Paclitaxel administered intravenously over 3 hours at a dose of 200 mg/m². Drug: Placebo to veliparib Capsules taken orally twice a day, 12 hours apart.

Arm

Intervention/Treatment

Experimental: Veliparib + Carboplatin + Paclitaxel

Participants received veliparib 120 mg orally twice daily (BID) on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an area under the concentration-time curve (AUC) 6 mg/mL/min and paclitaxel 200 mg/m² by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression.

Drug: Carboplatin

Carboplatin administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.

Drug: Veliparib

Capsules taken orally twice a day, 12 hours apart.

Other Names:

ABT-888

Drug: Paclitaxel

Paclitaxel administered intravenously over 3 hours at a dose of 200 mg/m².

Placebo Comparator: Placebo + Carboplatin + Paclitaxel

Participants received placebo orally BID on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an AUC 6 mg/mL/min and paclitaxel 200 mg/m² by IV infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression.

Drug: Carboplatin

Carboplatin administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.

Drug: Paclitaxel

Paclitaxel administered intravenously over 3 hours at a dose of 200 mg/m².

Drug: Placebo to veliparib

Capsules taken orally twice a day, 12 hours apart.

Outcome Measures

Primary Outcome Measures

Overall Survival (OS) in current smokers [Up to 3 years from first dose of study drug]
Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.

Secondary Outcome Measures

Overall Survival (OS) in all subjects [Up to 3 years from first dose of study drug]
Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.
Progressive-Free Survival (PFS) in current smokers and in all subjects [Up to 3 years from first dose of study drug]
Defined as the number of days from the date that the subject was randomized to the date the subject experiences an event of disease progression or to the date of death (all causes of mortality) if disease progression is not reached.
Objective Response Rate (ORR) in current smokers and in all subjects [Up to 3 years from first dose of study drug]
Objective response rate is defined as the proportion of subjects with complete or partial response as determined by the investigator per RECIST (version 1.1)

Other Outcome Measures

Change in Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life Core 30 Question Questionnaire (EORTC-QLQ-C30). [From Screening (prior to dosing) up to 2 years]
Change in Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life Lung Cancer 13 Question Questionnaire (EORTC-LC13). [From Screening (prior to dosing) up to 2 years]
Change in Eastern Cooperative Oncology Group (ECOG) Performance Status [From Screening (prior to dosing) up to 2 years]
Change in Quality of Life: European Quality of Life-5 Dimensions-5 Levels Questionnaire (EQ-5D-5L) [From Screening (prior to dosing) up to 2 years]
Duration of Response [From complete or partial response to disease progression (up to 3 years from randomization).]
The duration of overall response for a given subject will be defined as the number of days from the day the criteria are met for Complete or Partial Response (whichever is recorded first) to the date that Progressive Disease (PD) is objectively documented.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Life expectancy > 12 weeks
Subject must have cytologically or histologically confirmed squamous NSCLC.
Subject must have advanced or metastatic squamous NSCLC that is not amenable to surgical resection or radiation with curative intent at time of study Screening.
Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable to surgical resection or radiation with curative intent are eligible.
Subject must have at least 1 unidimensional measurable NSCLC lesion on a computerized tomography (CT) scan as defined by Response Evaluation Criteria In Solid Tumors (RECIST - version 1.1).

Exclusion Criteria:

Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
Subject has a known hypersensitivity to platinum compounds.
Subject has peripheral neuropathy >= grade 2.
Subject has non-squamous NSCLC, or a known epidermal growth factor receptor (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21, or a known anaplastic lymphoma kinase (ALK) gene rearrangement.
Subject has received prior cytotoxic chemotherapy (including definitive chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northeast Arkansas Clinical Ch /ID# 128071	Jonesboro	Arkansas	United States	72401
2	LA Hem-Oncology Med Group /ID# 129178	Los Angeles	California	United States	90017
3	VA Eastern Colorado Healthcare System /ID# 128065	Aurora	Colorado	United States	80045
4	Holy Cross Hospital /ID# 128074	Fort Lauderdale	Florida	United States	33308
5	University of Florida - Archer /ID# 126476	Gainesville	Florida	United States	32610
6	Cancer Specialists of North Florida - Southpoint /ID# 127815	Jacksonville	Florida	United States	32256
7	Winship Cancer Institute of Emory University /ID# 124061	Atlanta	Georgia	United States	30322-1013
8	St. Luke's Mountain States Tumor Institute - Boise /ID# 124059	Boise	Idaho	United States	83712
9	Illinois Cancer Specialists /ID# 127468	Arlington Heights	Illinois	United States	60005
10	NorthShore University HealthSystem - Evanston Hospital /ID# 128585	Evanston	Illinois	United States	60201
11	Ingalls Memorial Hosp /ID# 128360	Harvey	Illinois	United States	60426
12	Midwestern Regional CTC /ID# 126124	Zion	Illinois	United States	60099
13	Goshen Center for Cancer Care /ID# 123875	Goshen	Indiana	United States	46526
14	Franciscan St. Francis Health /ID# 126678	Indianapolis	Indiana	United States	46237
15	Appalachian Regional Healthcare, Inc (ARH) /ID# 128061	Hazard	Kentucky	United States	41701
16	Henry Ford Health System /ID# 126500	Detroit	Michigan	United States	48202
17	Sparrow Regional Cancer Center, Sparrow Health System /ID# 127156	Lansing	Michigan	United States	48912
18	Minnesota Oncology Hematology, PA /ID# 127473	Minneapolis	Minnesota	United States	55404
19	Nebraska Hematology Oncology /ID# 127699	Lincoln	Nebraska	United States	68506
20	SE Nebraska Hema/Oncology Consultants P.C.d/b/a Southeast Nebraska Cancer Center /ID# 126477	Lincoln	Nebraska	United States	68510
21	Comprehensive Cancer Ctrs Neva /ID# 127491	Las Vegas	Nevada	United States	89169
22	Dartmouth-Hitchcock Medical Center /ID# 128075	Lebanon	New Hampshire	United States	03756
23	Hackensack Univ Med Ctr /ID# 124057	Hackensack	New Jersey	United States	07601
24	Gabrail Cancer Center Research /ID# 127415	Canton	Ohio	United States	44718
25	Penn State University and Milton S. Hershey Medical Center /ID# 126676	Hershey	Pennsylvania	United States	17033
26	The Jones Clinic, PC /ID# 124062	Germantown	Tennessee	United States	38138
27	Texas Oncology - Austin Midtown /ID# 127477	Austin	Texas	United States	78705
28	Texas Oncology - South Austin /ID# 127476	Austin	Texas	United States	78745
29	Parkland Health and Hosp Syste /ID# 128518	Dallas	Texas	United States	75235
30	Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 128385	Dallas	Texas	United States	75246-2003
31	UT Southwestern Medical Center /ID# 127876	Dallas	Texas	United States	75390-7208
32	University of Texas MD Anderson Cancer Center /ID# 127946	Houston	Texas	United States	77030
33	Texas Oncology - Paris /ID# 127484	Paris	Texas	United States	75460
34	Texas Oncology - Waco /ID# 127459	Waco	Texas	United States	76712
35	University of Vermont Medical Center /ID# 128064	Burlington	Vermont	United States	05401-1473
36	Virginia Oncology Associates /ID# 127458	Norfolk	Virginia	United States	23502
37	Northwest Cancer Specialists, P.C. /ID# 127486	Vancouver	Washington	United States	98684
38	Northwest Cancer Specialists, P.C. /ID# 127488	Vancouver	Washington	United States	98684
39	Southern Medical Day Care Ctr /ID# 125604	Wollongong	New South Wales	Australia	2500
40	Sunshine Coast University Hosp /ID# 125608	Birtinya	Queensland	Australia	4575
41	The Townsville Hospital /ID# 125609	Douglas	Queensland	Australia	4814
42	Flinders Centre for Innovation /ID# 125605	Bedford Park	South Australia	Australia	5042
43	The Queen Elizabeth Hospital /ID# 125607	Woodville	South Australia	Australia	5011
44	Barwon Health University Hospital Geelong /ID# 125606	Geelong	Victoria	Australia	3220
45	Ordensklinikum Linz GmbH, Elisabethinen /ID# 126183	Linz		Austria	4020
46	Bobruysk Interdistrict Onco. /ID# 128999	Bobruisk		Belarus	213825
47	Brest Regional Hospital /ID# 125955	Brest		Belarus	224027
48	State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 125815	Lesnoy		Belarus	223040
49	Mogilev Reg Clin Oncology Dis /ID# 128639	Mogilev		Belarus	212018
50	Vitebsk Reg Clin Onc Disp /ID# 125516	Vitebsk		Belarus	210603
51	Hospital Sao Lucas da PUCRS /ID# 127737	Porto Alegre	Rio Grande Do Sul	Brazil	90610-000
52	Clinica de Neoplasias Litoral - Centro de Novos Tratamentos Itajai /ID# 127738	Itajai	Santa Catarina	Brazil	88301-220
53	Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 126736	Barretos	Sao Paulo	Brazil	14784-400
54	Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 127309	Rio de Janeiro		Brazil	20231-050
55	Instituto COI de Educacao e Pesquisa /ID# 127739	Rio de Janeiro		Brazil	22793-080
56	Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 126737	Sao Paulo		Brazil	01509-000
57	University of Calgary /Id# 126326	Calgary	Alberta	Canada	T2N 4Z6
58	Cross Cancer Institute /ID# 126154	Edmonton	Alberta	Canada	T6G 1Z2
59	Juravinski Cancer Clinic /ID# 126153	Hamilton	Ontario	Canada	L8V 1C3
60	Victoria Hospital /ID# 126669	London	Ontario	Canada	N6A 4L6
61	The Ottawa Hospital /ID# 126522	Ottawa	Ontario	Canada	K1H 8L6
62	Princess Margaret Cancer Centre /ID# 126155	Toronto	Ontario	Canada	M5G 2M9
63	McGill Univ HC /ID# 130431	Montreal	Quebec	Canada	H3G 1A4
64	CSSS Alphonse-Desjardins, CHAU de Levis /ID# 126149	Quebec City	Quebec	Canada	G6V 3Z1
65	Iucpq-Ul /Id# 126524	Québec	Quebec	Canada	G1V 4G5
66	Klinika za plucne bolesti Jordanovac /ID# 126537	Zagreb	Grad Zagreb	Croatia	10000
67	Klinicki bolnicki centar Osijek /ID# 132214	Osijek	Osjecko-baranjska Zupanija	Croatia	31000
68	Opca bolnica Pula /ID# 126540	Pula		Croatia	52100
69	Opca bolnica Dr. Josip Bencevi /ID# 126539	Slavonski Brod		Croatia	35000
70	Fakultni Nemocnice Olomouc /ID# 125820	Olomouc	Olomoucky Kraj	Czechia	779 00
71	Nemocnice Na Plesi s.r.o. /ID# 125817	Nová Ves pod Pleší	Pribram	Czechia	262 04
72	Nemocnice Kyjov, prispevkova organizace /ID# 125819	Kyjov		Czechia	697 01
73	Nemocnice Novy Jicin /ID# 125818	Nový Jičín 1		Czechia	741 01
74	Vitkovicka nemocnice a. s. /ID# 127023	Ostrava		Czechia	703 84
75	Herlev Hospital /ID# 125995	Herlev	Hovedstaden	Denmark	2730
76	Odense Universitets Hospital /ID# 125996	Odense C	Syddanmark	Denmark	5000
77	University of Alexandria /ID# 128337	Alexandria		Egypt	21131
78	Naser Institute for Res & Dev /ID# 129263	Cairo		Egypt	11511
79	Cairo Uni Hosp Al Kasr El Ainy /ID# 128338	Cairo		Egypt	11956
80	Cairo Uni Hosp Al Kasr El Ainy /ID# 128340	Cairo		Egypt	11956
81	North Estonian Medical Centre /ID# 128215	Tallinn		Estonia	13419
82	Tartu University Hospital /ID# 127735	Tartu		Estonia	51014
83	Helsinki Univ Central Hospital /ID# 125897	Helsinki		Finland	00290
84	Vaasa Central Hospital /ID# 125896	Vaasa		Finland	65130
85	CHU Hopital Nord /ID# 128388	Marseille	Bouches-du-Rhone	France	13915
86	Hopital Haut-Lévêque /ID# 135270	Pessac CEDEX	Gironde	France	33604
87	CHRU Lille - Hôpital Claude Huriez /ID# 126353	Lille CEDEX	Hauts-de-France	France	59045
88	Centre Hospitalier Le Mans /ID# 127902	Le Mans CEDEX 9	Sarthe	France	72037
89	Centre Hosp Intercommunal de Creteil /ID# 125922	Creteil	Val-de-Marne	France	94000
90	CHRU de Brest - Hopital Morvan /ID# 127903	Brest		France	29200
91	Centre Antoine Lacassagne /ID# 126360	Nice		France	06189
92	Hospital Pontchaillou /ID# 126356	Rennes		France	35033
93	Hopital Larrey - CHU de Toulouse /ID# 128394	Toulouse		France	31059
94	Charite-Univ. Berlin, Benjamin-Franklin /ID# 125708	Berlin		Germany	12203
95	Lungen Clinic Grosshansdorf /ID# 126107	Grosshansdorf		Germany	22927
96	Klinikum Kassel /ID# 127025	Kassel		Germany	34125
97	Klinik Loewenstein GmbH /ID# 126191	Löwenstein		Germany	74245
98	Univ Johannes Gutenberg /ID# 125603	Mainz		Germany	55131
99	Papageorgiou General Hospital Thessaloniki /ID# 125876	Nea Efkarpia	Thessaloniki	Greece	54603
100	General Hospital of Chest Diseases of Athens SOTIRIA /ID# 125879	Athens		Greece	11527
101	Metropolitan Hospital /ID# 125878	Athens		Greece	18547
102	University General Hospital of Heraklion PA.G.N.I /ID# 125877	Heraklion		Greece	71110
103	CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 135234	Miskolc	Borsod-Abauj-Zemplen	Hungary	3529
104	Orszagos Koranyi Pulmonologiai Intezet /ID# 126112	Budapest XII	Budapest	Hungary	1122
105	Debreceni Egyetem Klinikai Központ /ID# 126119	Debrecen		Hungary	4032
106	Veszprem Megyei Tudogyogyintez /ID# 126121	Farkasgyepu		Hungary	8582
107	Petz Aladar Megyei Oktato Korh /ID# 126110	Gyor		Hungary	9023
108	Bekes Megyei Pandy Kalman Korhaz /ID# 126117	Gyula		Hungary	5700
109	Matrahaza Gyogyintezet /ID# 126109	Kékesteto		Hungary	3233
110	Fejer Megyei Szent Gyorgy Korh /ID# 126118	Szekesfehervar		Hungary	8000
111	Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 126120	Szolnok		Hungary	5004
112	Tudogyogyintezet Toeroekbalint /ID# 126111	Torokbalint		Hungary	2045
113	St. James's Hospital /ID# 126177	Dublin 8	Dublin	Ireland	D08 E9P6
114	Cork University Hospital /ID# 126176	Cork		Ireland	T12 E8YV
115	Beaumont Hospital /ID# 126218	Dublin		Ireland	D09 XR63
116	University Hospital Limerick /ID# 126175	Limerick		Ireland	V94F858
117	University Hospital Waterford /ID# 126178	Waterford		Ireland	X91 ER8E
118	Assaf Harofeh Medical Center /ID# 127076	Be'er Ya'akov		Israel	70300
119	Hadassah University Hospital /ID# 127077	Jerusalem		Israel	91120
120	Meir Medical Center /ID# 127078	Kfar Saba		Israel	4428164
121	Sheba Medical Center /ID# 127079	Ramat Gan		Israel	5239424
122	AO San Giuseppe Moscati /ID# 125701	Avellino		Italy	83100
123	Istituto Europeo di Oncologia /ID# 125702	Milan		Italy	20141
124	Azienda Ospedaliera San Gerardo di Monza _ Oncologia Medica /ID# 125704	Monza		Italy	20052
125	A.O.U. San Luigi Gonzaga /ID# 125700	Orbassano		Italy	10043
126	Azienda Ospedaliero Uni Parma /ID# 125703	Parma		Italy	43100
127	Azienda Ospedaliera-Universitaria di Perugia-Divisione di Oncologia Medica. /ID# 125699	Perugia		Italy	06100
128	Istituto Oncologico del Medite /ID# 132844	Viagrande		Italy	95029
129	Riga East Clinical Univ Hosp /ID# 125597	Riga		Latvia	1038
130	P. Stradins Clinical Univ Hosp /ID# 126322	Riga		Latvia	LV-1002
131	Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127176	Kovno	Kaunas	Lithuania	50009
132	National Cancer Institute /ID# 126323	Vilnius		Lithuania	08660
133	Centro Estatal de Cancerologia /ID# 127583	Chihuahua		Mexico	31000
134	Hospital Angeles Centro Medico /ID# 127620	San Luis Potosí		Mexico	78216
135	Cancerologia de Queretaro S.C. /ID# 125920	Santiago de Querétaro		Mexico	76178
136	Vrije Universiteit Medisch Centrum /ID# 125578	Amsterdam		Netherlands	1081 HV
137	Amphia Ziekenhuis /ID# 126466	Breda		Netherlands	4818 CK
138	Catharina Ziekenhuis /ID# 125577	Eindhoven		Netherlands	5623 EJ
139	Ziekenhuis St. Jansdal /ID# 125576	Harderwijk		Netherlands	3844 DG
140	Atrium-Orbis Zuyderland Medisch Centrum /ID# 125710	Heerlen		Netherlands	6419 PC
141	Jeroen Bosch Ziekenhuis /ID# 125709	S Hertogenbosch		Netherlands	5223 GZ
142	Isala /ID# 125579	Zwolle		Netherlands	8025 AB
143	Wellington Hospital (Capital and Coast District Health Board) /ID# 125755	Wellington		New Zealand	6021
144	Haukeland University Hospital /ID# 126338	Bergen	Hordaland	Norway	5021
145	Nordland Hospital /ID# 126337	Bodø		Norway	8005
146	Sorlandet Sykehus HF /ID# 126341	Kristiansand		Norway	4615
147	Oslo Universitetssykehus, Radiumhospitalet /ID# 126335	Oslo		Norway	0310
148	Stavanger University Hospital /ID# 126336	Stavanger		Norway	4068
149	Sykehuset i Vestfold HF /ID# 126340	Tonsberg		Norway	3116
150	Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 126548	Rzeszów	Podkarpackie	Poland	35-021
151	Szpital Morski im. PCK /ID# 126547	Gdynia		Poland	81-519
152	NZOZ Magodent Ctr. Med. Ostro /ID# 126545	Warsaw		Poland	04-125
153	Mazowiecki Szpital Onkologiczn /ID# 126546	Wieliszew		Poland	05-135
154	Hospital Senhora da Oliveira de Guimaraes, EPE /ID# 126761	Guimaraes	Braga	Portugal	4835-044
155	CCA Braga - Hospital de Braga /ID# 125837	Braga		Portugal	4710-243
156	Ctr Hosp Univ Coimbra, EPE /ID# 125838	Coimbra		Portugal	3000-075
157	Hospital Pulido Valente /ID# 125835	Lisbon		Portugal	1769-001
158	IPO Porto FG, EPE /ID# 125836	Porto		Portugal	4200-072
159	Centro Hospitalar de Sao Joao, EPE /ID# 125875	Porto		Portugal	4200-319
160	VA Caribbean Healthcare System /ID# 124562	San Juan		Puerto Rico	00921-3201
161	Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 128458	Moscow	Moskva	Russian Federation	115478
162	Sverdlovsk Regional Oncology Center Dispensary /ID# 128457	Ekaterinburg	Sverdlovskaya Oblast	Russian Federation	620043
163	Volgograd Regional Clinical Oncology Dispensary /ID# 126350	Volgograd	Volgogradskaya Oblast	Russian Federation	400138
164	Belgorod Oncology Dispensary /ID# 129899	Belgorod		Russian Federation	308010
165	State Budgetary Healthcare Institution"Irkutsk Regional Oncology Center /ID# 128460	Irkutsk		Russian Federation	664035
166	State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 128461	Murmansk		Russian Federation	183047
167	Orenburg Regional Clinical Onc /ID# 137474	Orenburg		Russian Federation	460021
168	Ogarev Mordovia State Univ /ID# 127595	Saransk		Russian Federation	430005
169	Smolensk Regional Onc Clin Dis /ID# 127144	Smolensk		Russian Federation	214009
170	Cancer Research Institute Siberian Branch of the Russian Academy of Medical Scie /ID# 127143	Tomsk		Russian Federation	634050
171	Clinical Center Serbia /ID# 128738	Belgrade	Beograd	Serbia	11000
172	Clinical Center of Nis /ID# 128735	NIS	Nisavski Okrug	Serbia	18000
173	Institute for Oncology and Rad /ID# 128721	Belgrade		Serbia	11000
174	University Hospital Bezanijska /ID# 128761	Belgrade		Serbia	11080
175	Institute For Pulmonary Diseas /ID# 128737	Sremska Kamenica		Serbia	21204
176	Univerzitna Nemocnica Bratislava /ID# 126342	Bratislava		Slovakia	821 01
177	MEDEON, s.r.o. /ID# 128517	Pieštany		Slovakia	921 01
178	GVI Oncology /ID# 126102	Port Elizabeth	Eastern Cape	South Africa	6006
179	Wits Clinical Research Site /ID# 126101	Johannesburg	Gauteng	South Africa	2193
180	Sandton Oncology Centre /ID# 126097	Johannesburg	Gauteng	South Africa	2199
181	University of Pretoria /ID# 127297	Pretoria	Gauteng	South Africa	0001
182	Dr Albert, Bouwer and Jordaan Incorporated /ID# 126098	Pretoria	Gauteng	South Africa	0044
183	Mary Potter Oncology Centre /ID# 126099	Pretoria	Gauteng	South Africa	0181
184	The Oncology Centre /ID# 126096	Durban	Kwazulu-Natal	South Africa	4091
185	Netcare Oncology Intervent Ctr /ID# 126100	Cape Town	Western Cape	South Africa	7460
186	Cancercare Outeniqua Oncology Unit /ID# 126103	George	Western Cape	South Africa	6530
187	Hospital Duran i Reynals /ID# 125161	L'Hospitalet de Llobregat	Barcelona	Spain	08907
188	Hospital Universitario Puerta de Hierro Majadahonda /ID# 125160	Majadahonda	Madrid	Spain	28222
189	Hospital Universitario Vall d'Hebron /ID# 125159	Barcelona		Spain	08035
190	Hospital Universitario HM Sanchinarro /ID# 125162	Madrid		Spain	28050
191	Hospital Universitario Virgen del Rocio /ID# 125207	Sevilla		Spain	41013
192	Fundacion Instituto Valenciano Oncologia IVO /ID# 125205	Valencia		Spain	46009
193	Gavle Sjukhus /ID# 126444	Gavle		Sweden	803 24
194	Sahlgrenska University Hosp /ID# 129997	Goteborg		Sweden	413 45
195	University Hospital Linkoping /ID# 126443	Linkoping		Sweden	581 85
196	Karolinska Univ Sjukhuset /ID# 126445	Solna		Sweden	17176
197	Kantonsspital St. Gallen /ID# 126349	St. Gallen	Sankt Gallen	Switzerland	9007
198	Hirslanden Medical Center /ID# 128216	Aarau		Switzerland	5000
199	Inselspital, Universitaetsklinik /ID# 126347	Bern		Switzerland	3010
200	Spital STS AG /ID# 126348	Thun		Switzerland	3600
201	Akdeniz University Medical Fac /ID# 126997	Antalya		Turkey	07059
202	Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 126186	Istanbul		Turkey	34098
203	Marmara University Medical Fac /ID# 126187	Istanbul		Turkey	34899
204	Ege University Medical Faculty /ID# 126189	Izmir		Turkey	35040
205	Dr. Suat Seren Gogus Has /ID# 126190	Izmir		Turkey	35110
206	Communal non-profit enterprise Regional Center of Oncology /ID# 128221	Kharkiv	Kharkivska Oblast	Ukraine	61070
207	Cherkassy Regional Onc Ctr /ID# 128222	Cherkasy		Ukraine	18000
208	Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 128220	Chernivtsi		Ukraine	58013
209	Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 128217	Dnipro		Ukraine	49102
210	Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 128218	Lviv		Ukraine	79031
211	Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 128223	Poltava		Ukraine	36011
212	Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical /ID# 128219	Sumy		Ukraine	40022
213	Cheltenham General Hospital /ID# 125692	Cheltenham	Gloucestershire	United Kingdom	GL53 7AN
214	Guy's and St Thomas' NHS Found /ID# 125694	London	London, City Of	United Kingdom	SE1 9RT
215	Norfolk and Norwich Univ Hosp /ID# 125697	Norwich	Norfolk	United Kingdom	NR4 7UY
216	Betsi Cadwaladr Univ Health Bo /ID# 127177	Bangor		United Kingdom	LL57 2PW
217	North Devon District Hospital /ID# 125689	Barnstaple		United Kingdom	ES31 4JB
218	The Royal Bournemouth Hospital /ID# 125690	Bournemouth		United Kingdom	BH7 7DW
219	East Kent Hosp Univ NHS Trust /ID# 125698	Canterbury		United Kingdom	CT1 3NG
220	Gartnavel General Hospital /ID# 126233	Glasgow		United Kingdom	G12 0YN
221	James Paget University Hosp /ID# 125696	Great Yarmouth		United Kingdom	NR31 6LA
222	Charing Cross Hospital /ID# 125688	London		United Kingdom	W6 8RF
223	Maidstone Hospital /ID# 125693	Maidstone		United Kingdom	ME16 9QQ
224	The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 129228	Newcastle Upon Tyne		United Kingdom	NE7 7DN
225	The Clatterbridge Cancer Ctr /ID# 125695	Wirral		United Kingdom	CH63 4JY