ATLAS: A Phase 3 Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer

Sponsor

UroGen Pharma Ltd. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04688931

Collaborator

(none)

632

Enrollment

139

Locations

Arms

33.3

Anticipated Duration (Months)

4.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a global, randomized, controlled, open-label Phase 3 study designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors (TURBT) versus TURBT alone for the treatment of patients with low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC).

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer Urothelial Carcinoma Urothelial Carcinoma Bladder	Drug: UGN-102 Procedure: TURBT	Phase 3

Detailed Description

Eligible patients will be randomized in a 1:1 ratio to UGN-102 ± TURBT or TURBT alone. Randomization will be stratified by the presence of a previous LG NMIBC episode within 1 year of the current diagnosis (yes or no). Starting at Day 1, patients randomized to the UGN-102 ± TURBT group will receive 6 once-weekly intravesical instillations of UGN-102 and patients randomized to the TURBT alone group will undergo TURBT.

Patients in both treatment groups will return to the clinic at approximately 3 months after the initiation of treatment (7 weeks ± 1 week after the last weekly instillation for the UGN-102 ± TURBT group and 12 weeks ± 1 week after TURBT for the TURBT alone group) to determine response to treatment. Patients determined to have a complete response (CR) will receive no further treatment and will enter the follow-up period of the study. Patients determined to have a non-complete response (NCR) will undergo TURBT of any remaining lesions and will then enter the follow-up period of the study.

During the follow-up period, patients will return to the clinic every 3 months to determine durability of response. Patients will remain on study until completion of all follow-up visits (approximately 24 months after the initiation of treatment) or until recurrence or death is documented, whichever occurs first. Patients determined to have a protocol-defined recurrence at any follow-up or unscheduled visit will be considered to have completed the study and released to the care of their treating physician.

The study is event-driven and patients may be followed beyond 24 months or additional patients may be enrolled to achieve the target number of events required for the study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

632 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Controlled, Open-Label Study of the Efficacy, Durability, and Safety of UGN-102 With or Without TURBT in Patients With Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer (LG IR NMIBC)

Actual Study Start Date :

Feb 19, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: UGN-102 ± TURBT 6 once-weekly intravesical instillations of 75 mg UGN-102 starting at Day 1 + TURBT for patients who have a NCR at the 3-month disease assessment (7 weeks ± 1 week after the last weekly instillation of UGN-102).	Drug: UGN-102 UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-102 allow for local administration of mitomycin as a liquid, with subsequent conversion to a semi-solid gel depot following instillation into the bladder. Other Names: UGN-102 (mitomycin) for intravesical solution Procedure: TURBT The current standard of care for treatment of LG IR NMIBC is TURBT under general anesthesia. Other Names: Transurethral resection of bladder tumors
Active Comparator: TURBT Alone TURBT on Day 1 + repeat TURBT for patients who have a NCR at the 3-month disease assessment (12 weeks ± 1 week after the initial TURBT).	Procedure: TURBT The current standard of care for treatment of LG IR NMIBC is TURBT under general anesthesia. Other Names: Transurethral resection of bladder tumors

Arm

Intervention/Treatment

Experimental: UGN-102 ± TURBT

6 once-weekly intravesical instillations of 75 mg UGN-102 starting at Day 1 + TURBT for patients who have a NCR at the 3-month disease assessment (7 weeks ± 1 week after the last weekly instillation of UGN-102).

Drug: UGN-102

UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-102 allow for local administration of mitomycin as a liquid, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.

Other Names:

UGN-102 (mitomycin) for intravesical solution

Procedure: TURBT

The current standard of care for treatment of LG IR NMIBC is TURBT under general anesthesia.

Other Names:

Transurethral resection of bladder tumors

Active Comparator: TURBT Alone

TURBT on Day 1 + repeat TURBT for patients who have a NCR at the 3-month disease assessment (12 weeks ± 1 week after the initial TURBT).

Procedure: TURBT

The current standard of care for treatment of LG IR NMIBC is TURBT under general anesthesia.

Other Names:

Transurethral resection of bladder tumors

Outcome Measures

Primary Outcome Measures

Disease-free survival (DFS) [Up to 24 months]
DFS is defined the same way in both treatment groups, however, it is defined differently for patients who have a CR or NCR at the 3-month disease assessment. For patients who have a CR at 3 months, DFS is defined as the time from randomization to the earliest date of disease recurrence or death due to any cause. Patients who have a NCR at 3 months will be treated with TURBT in both treatment groups and DFS is defined as the time from this TURBT to the earliest date of disease recurrence or death due to any cause.

Secondary Outcome Measures

Time to recurrence (TTR) [Up to 24 months]
TTR is defined the same way in both treatment groups, however, it is defined differently for patients who have a CR or NCR at the 3-month disease assessment. For patients who have a CR at 3 months, TTR is defined as the time from randomization to the first documented disease recurrence. Patients who have a NCR at 3 months will be treated with TURBT in both treatment groups and TTR is defined as the time from this TURBT to the first documented disease recurrence.
Complete response rate (CRR) [3 months]
CRR is defined as the percentage of patients who achieve CR at the 3-month disease assessment.
Duration of response (DOR) [Up to 24 months]
DOR is defined as the time from first documented CR to the date of first documented disease recurrence or death due to any cause among patients who achieve CR at the 3-month disease assessment.
Observed CRR at scheduled disease assessment timepoint [Up to 24 months]
Observed CRR at scheduled disease assessment timepoint is defined as the percentage of patients who achieve CR at the 3-month disease assessment and maintain CR up to a particular follow-up disease assessment.
Incidence of TURBT [Up to 24 months]
Incidence of TURBT is defined as the percentage of patients requiring TURBT and the average number of TURBTs per patient in each treatment group.
Changes from baseline in health-related quality of life [Up to 24 months]
The European Organisation for Research and Treatment of Cancer (EORTC) 24-item quality of life questionnaire for patients with NMIBC (QLQ-NMIBC24) is a patient-reported instrument that assesses 11 domains (urinary symptoms, malaise, future worries, bloating and flatulence, intravesical treatment issues, sexual intimacy, risk of contaminating partner, male sexual problems, female sexual problems, sexual function, and sexual enjoyment). Descriptive statistics will be used to summarize the scored scales for each of the domains and the change from baseline in the domain scores at each scheduled assessment time point.
Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, and abnormal clinical laboratory test results (hematology, serum chemistry, and urinalysis). [Up to 24 months]
The percentage of patients with each type of event will be summarized.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
Patient who has newly diagnosed or historic LG NMIBC (Ta) histologically confirmed by cold cup biopsy at screening or within 8 weeks of screening.
Is at intermediate risk for progression, defined as having 1 or 2 of the following:

Presence of multiple tumors;
Solitary tumor > 3 cm;
Recurrence (≥ 1 occurrence of LG NMIBC within 1 year of the current diagnosis).

Negative voiding cytology for high grade (HG) disease within 6 weeks of screening.
Has adequate organ and bone marrow function as determined by the following routine laboratory tests:

Leukocytes ≥ 3,000 cells per μL;
Absolute neutrophil count ≥ 1,500 cells per μL;
Platelets ≥ 100,000 per μL;
Hemoglobin ≥ 9.0 g/dL;
Total bilirubin ≤ 1.5 x upper limit of normal (ULN);
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;
Alkaline phosphatase (ALP) ≤ 2.5 × ULN;
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.

Has no evidence of active urinary tract infection (UTI).
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for clinical study participants. Women of childbearing potential (defined as premenopausal women who have not been sterilized), including female patients and female partners of male patients, must be willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post-treatment.

Exclusion Criteria:

History of carcinoma in situ (CIS) on preliminary cystoscopy within 5 years of enrollment.
Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 1 year.
History of HG papillary UC in the past 2 years.
Known allergy or sensitivity to mitomycin that in the investigator's opinion cannot be readily managed.
Clinically significant urethral stricture that would preclude passage of a urethral catheter.
History of pelvic radiotherapy.
History of:

Neurogenic bladder;
Active urinary retention;
Any other condition that would prohibit normal voiding.

Past or current muscle invasive (ie, T2, T3, T4) or metastatic UC or concurrent upper tract UC.
Current tumor grading of T1.
Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the investigator, the patient would be unable to comply with the protocol.
History of prior treatment with an intravesical chemotherapeutic agent except for a single dose of chemotherapy immediately post any previous TURBT.
Has previously participated in a study in which they received UGN-102.
Has participated in a study with an investigational agent or device within 30 days of randomization.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Institute of Urology, PLLC	Tucson	Arizona	United States	85704
2	Loma Linda University Medical Center	Loma Linda	California	United States	92350
3	Urology Group of Southern California	Los Angeles	California	United States	90017
4	San Diego Clinical Trials	San Diego	California	United States	92120
5	Providence Saint John's Health Center	Santa Monica	California	United States	90404
6	Skyline Urology	Sherman Oaks	California	United States	91411
7	University of Chicago Hospital	Chicago	Illinois	United States	60637
8	Comprehensive Urologic Care	Lake Barrington	Illinois	United States	60010
9	First Urology, PSC	Jeffersonville	Indiana	United States	47130
10	Wichita Urology Group	Wichita	Kansas	United States	67226
11	Regional Urology, LLC	Shreveport	Louisiana	United States	71106
12	Chesapeake Urology Research Associates	Baltimore	Maryland	United States	21204
13	Chesapeake Urology Research Associates	Hanover	Maryland	United States	21076
14	Adult & Pediatric Urology, PC	Omaha	Nebraska	United States	68114
15	Urology Center	Las Vegas	Nevada	United States	89144
16	New Jersey Urology	Bloomfield	New Jersey	United States	07003
17	New Jersey Urology	Englewood	New Jersey	United States	07631
18	Garden State Urology	Morristown	New Jersey	United States	07960
19	Albany Medical Center	Albany	New York	United States	12208
20	Great Lakes Physician dba WNY Urology Associates	Cheektowaga	New York	United States	14225
21	AccuMed Research Associates	Garden City	New York	United States	11530
22	Manhattan Medical Research	New York	New York	United States	10016
23	Stony Brook Cancer Center	Stony Brook	New York	United States	11794
24	Associated Medical Professionals of NY, PLLC	Syracuse	New York	United States	13210
25	UNC Chapel Hill Memorial Hospital	Chapel Hill	North Carolina	United States	27599
26	Clinical Research Solutions	Middleburg Heights	Ohio	United States	44130
27	Centers for Advanced Urology, LLP d.b.a Mid-Atlantic Urology	Bala-Cynwyd	Pennsylvania	United States	19004
28	Penn State Health Milton S. Hershey Medical Center and College of Medicine	Hershey	Pennsylvania	United States	17033
29	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
30	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15237
31	Carolina Urologic Research Center	Myrtle Beach	South Carolina	United States	29572
32	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390
33	Urology San Antonio	San Antonio	Texas	United States	78229
34	Multiprofile Hospital for Active Treatment "Puls", Department of Urology	Blagoevgrad		Bulgaria	2700
35	Multiprofile Hospital for Active Treatment - Blagoevgrad	Blagoevgrad		Bulgaria	2700
36	Complex Oncology Center - Burgas	Burgas		Bulgaria	8000
37	Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology	Gabrovo		Bulgaria	5300
38	Multiprofile Hospital for Active Treatment "Sveti Nikolai Chudotvorets", Lom	Lom		Bulgaria	3600
39	Multiprofile Hospital for Active Treatment "City Clinic - Sveti Georgi"	Montana		Bulgaria	3400
40	University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic	Pleven		Bulgaria	5800
41	University Multiprofile Hospital for Active Treatment "Sveta Marina" - Pleven, Department of Urology	Pleven		Bulgaria	5800
42	Multiprofile Hospital for Active Treatment Park Hospital	Plovdiv		Bulgaria	4000
43	University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Clinic of Urology	Plovdiv		Bulgaria	4002
44	University Multiprofile Hospital for Active Treatment, Plovdiv, Department of Urology	Plovdiv		Bulgaria	4003
45	University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology	Ruse		Bulgaria	7000
46	Multiprofile Hospital for Active Treatment - Shumen, Shumen, Department of Urology	Shumen		Bulgaria	9700
47	University Multiprofile Hospital for Active Treatment "Aleksandrovska", Sofia, Urology Clinic	Sofia		Bulgaria	1431
48	University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic	Sofia		Bulgaria	1606
49	Multiprofile Hospital for Active Treatment - Targovishte	Targovishte		Bulgaria	7700
50	Multiprofile Hospital for Active Treatment, Varna part of Military Medical Academy, Clinic of Urology	Varna		Bulgaria	9000
51	Multiprofile Hospital for Active Treatment "Sveta Anna", Varna, Urology Clinic	Varna		Bulgaria	9002
52	University Multiprofile Hospital for Active Treatment "Sveta Marina"	Varna		Bulgaria	9010
53	Multiprofile Regional Hospital for Active Treatment "Dr. Stefan Cherkezov", Veliko Tarnovo, Department of Urology	Veliko Tarnovo		Bulgaria	5000
54	First Private Hospital Vratsa, Department of Urology	Vratsa		Bulgaria	3001
55	Multiprofile Hospital for Active Treatment "Sveti Pantaleymon", Yambol, Department of Urology	Yambol		Bulgaria	8600
56	East Viru Central Hospital, Surgery Clinic	Kohtla-Järve		Estonia	31025
57	East Tallinn Central Hospital Ltd., Surgery Clinic, Centre of Urology	Tallinn		Estonia	10138
58	West Tallinn Central Hospital Ltd., Department of Urology	Tallinn		Estonia	10617
59	North Estonia Medical Centre Foundation Ltd., Surgery Clinic, General and Oncology Urology Centre	Tallinn		Estonia	13419
60	Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation	Tartu		Estonia	50406
61	LTD Central University Clinic After Academic N. Kipshidze	Tbilisi		Georgia	0160
62	JSC Jerarsi, Department of Urology	Tbilisi		Georgia
63	LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine, Clinical Research Department	Tbilisi		Georgia
64	LTD Gidmedi, Urology Department	Tbilisi		Georgia
65	LTD L. Managadze National Center of Urology, Department of Urology	Tbilisi		Georgia
66	LTD MMT Hospital, Urology Department	Tbilisi		Georgia
67	Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD, Department of Urology	Tbilisi		Georgia
68	Pineo Medical Ecosystem Ltd., Department of Urology	Tbilisi		Georgia
69	Tbilisi State Medical University and Ingorokva High Technology Medical Center University Clinic LTD, Urology Department	Tbilisi		Georgia
70	Rambam Health Care Campus	Haifa		Israel	31096
71	Lady Davis Carmel Medical Center	Haifa		Israel	3436212
72	Edith Wolfson Medical Center	H̱olon		Israel	58100
73	Rabin Medical Center	Petah tikva		Israel	49100
74	Chaim Sheba Medical Center	Ramat Gan		Israel	5262000
75	Liepajas Regional Hospital, Urology Department	Liepāja		Latvia	LV-3414
76	P. Stradins Clinical University Hospital, Center for Urology	Riga		Latvia	LV-1002
77	LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology	Riga		Latvia	LV-1038
78	Daugavpils Regional Hospital, Urology Department	Riga		Latvia	LV-5417
79	Jan Biziel University Hospital #2 in Bydgoszcz, Teaching Department of Urology	Bydgoszcz		Poland	85-168
80	AKMED	Gliwice		Poland	44-100
81	Prof.E Michalowski Specialist Hospital	Katowice		Poland	40-073
82	SCM sp. z o.o. (LLC)	Kraków		Poland	31-559
83	"City Clinic" Limited Liability Company	Warsaw		Poland	02-473
84	Miedzyleski Specialist Hospital in Warsaw, Department of Urology	Warsaw		Poland	04-749
85	Sverdlovsk Regional Clinical Hospital #1	Ekaterinburg		Russian Federation	620102
86	Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center	Krasnoyarsk		Russian Federation	660133
87	D.D. Pletnyov City Clinical Hospital, Department of Oncourology	Moscow		Russian Federation	105077
88	Moscow City Oncology Hospital #62	Moscow		Russian Federation	125130
89	Murmansk Bayandin Regional Clinical Hospital	Murmansk		Russian Federation	183047
90	Privolzhsky Regional Medical Center, Urology Department	Nizhny Novgorod		Russian Federation	603001
91	Tsyb Medical Radiology Research Center, Oncourology Department	Obninsk		Russian Federation	249036
92	Clinical Oncology Center, Department of Urology and Oncology	Omsk		Russian Federation	644013
93	N.N. Burdenko Penza Regional Clinical Hospital, Department of Urology	Penza		Russian Federation	440026
94	Pyatigorsk City Clinical Hospital, Department of Urology	Pyatigorsk		Russian Federation	357500
95	Leningrad Regional Clinical Oncology Center, Department of Chemotherapy	Saint Petersburg		Russian Federation	188663
96	Aleksandrovskaya City Hospital, Department of Urology	Saint Petersburg		Russian Federation	193312
97	St. Petersburg Clinical Hospital under the Russian Academy of Sciences, Department of Urology	Saint Petersburg		Russian Federation	194017
98	A.M. Nikiforov Russian Center for Emergency and Radiology Medicine, Department of Urology	Saint Petersburg		Russian Federation	194044
99	St. Luka Clinical Hospital, Department of Urology	Saint Petersburg		Russian Federation	194044
100	St.-Petersburg Scientific Research Institute of Phthisiopulmonology	Saint Petersburg		Russian Federation	194064
101	Medical and Sanitary Unit #70 of "Passazhiravtotrans"	Saint Petersburg		Russian Federation	195009
102	I.I. Mechnikov North-Western State Medical University, Department of Urology	Saint Petersburg		Russian Federation	195067
103	Railway Clinical Hospital under OAO Russian Railways	Saint Petersburg		Russian Federation	195271
104	First I.P. Pavlov State Medical University of St. Petersburg	Saint Petersburg		Russian Federation	197022
105	N.N. Petrov National Medical Research Center of Oncology, Oncourology Department	Saint Petersburg		Russian Federation	197758
106	City Hospital #15, Urology Department #12	Saint Petersburg		Russian Federation	198205
107	Siberian State Medical University	Tomsk		Russian Federation	634050
108	Regional Oncology Center, Tyumen, Oncology Department	Tyumen		Russian Federation	625041
109	Republican Clinical Oncology Center	Ufa		Russian Federation	450054
110	Volgograd Regional Center for Urology and Nephrology, Urology Department	Volzhskiy		Russian Federation	404120
111	Medical Center for Diagnostics and Prevention Plus	Yaroslavl		Russian Federation	150040
112	Clinical Center of Serbia, Clinic of Urology	Belgrade		Serbia	11000
113	Clinical Hospital Center Bezanijska Kosa, Clinic of Surgery, Department of Urology	Belgrade		Serbia	11080
114	Clinical Hospital Center Zemun, Urology unit	Belgrade		Serbia	11080
115	Clinical Center Kragujevac, Clinic of Urology, Nephrology and Dialysis	Kragujevac		Serbia	34000
116	Chernihiv Medical Center of Modern Oncology	Chernihiv		Ukraine	14029
117	Regional Communal Noncommercial Enterprise: Chernivtsi Regional Clinical Hospital	Chernivtsi		Ukraine	58001
118	Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital", Urology Department	Chernivtsi		Ukraine	58023
119	Public Enterprise "Dnipropetrovsk I.I. Mechnikov Regional Clinical Hospital" under Dnipropetrovsk Regional Council, Urology Department #2	Dnipro		Ukraine	49005
120	Public Non-Profit Enterprise "City Clinical Hospital #6" under Dnipro City Council, Department of Urology	Dnipro		Ukraine	49074
121	Public Non-Profit Enterprise "City Clinical Hospital #4" under Dnipro City Council, Department of Geriatric Urology Care	Dnipro		Ukraine	49102
122	Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council", Department of Urology	Ivano-Frankivs'k		Ukraine	76008
123	Prykarpattia Clinical Oncology Center under Ivano-Frankivsk Regional Council	Ivano-Frankivs'k		Ukraine	76018
124	Public Non-Profit Enterprise under Kharkiv Regional Council "V.I. Shapoval Regional Medical Clinical Center for Urology and Nephrology", Urology Department #5	Kharkiv		Ukraine	61037
125	Communal Non-Profit Enterprise "Regional Center of Oncology", Department of Oncourology	Kharkiv		Ukraine	61070
126	Public Non-Profit Enterprise under Kharkiv Regional Council "Regional Clinical Specialized Center for Radiation Protection of Population", Department of Surgery	Kharkiv		Ukraine	61166
127	Communal non-commercial enterprise of Kherson regional council "Kherson regional oncological dispensary"	Kherson		Ukraine	73000
128	State Institution: Institute of Urology under the National Academy of Medical Sciences of Ukraine	Kyiv		Ukraine	04053
129	Volyn Regional Medical Oncology Centre	Luts'k		Ukraine	43018
130	Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital", Department of Urology	Lviv		Ukraine	79010
131	Public Non-profit Enterprise under Lviv Regional Council: Lviv Regional Treatment and Diagnostics Oncology Center	Lviv		Ukraine	79031
132	Municipal Non-Profit Enterprise "Lviv Clinical Emergency Care Hospital", Department of Urology	Lviv		Ukraine	79059
133	Public Non-Profit Enterprise "Odesa Regional Clinical Hospital" under Odesa Regional Council	Odesa		Ukraine	65025
134	Public Non-Profit Enterprise "City Clinical Hospital #10" under Odesa City Council, Department of Urology and Nephrology	Odesa		Ukraine	65074
135	Sumy Regional Clinical Oncology Center	Sumy		Ukraine	40022
136	Public Non-Profit Enterprise Ternopil Regional Clinical Oncology Center, Department of Chemotherapy	Ternopil'		Ukraine	46023
137	Municipal non-profit enterprise "Transcarpathian antitumor center" of the Transcarpathian Regional Council	Uzhhorod		Ukraine	88014
138	Communal Nonprofit Enterprise "Podilsky Regional Center of Oncology of Vinnytsia Regional Council"	Vinnytsia		Ukraine	21029
139	Municipal Nonprofit Enterprise: Zaporizhia Regional Clinical Hospital under Zaporizhia Regional Council, Department of Urology	Zaporizhia		Ukraine	69600