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BRIEF TITLE: A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer

A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer


  • Org Study ID: D933SC00001
  • Secondary ID:
  • NCT ID: NCT03682068
  • NCT Alias:
  • Sponsor: AstraZeneca - Industry
  • Source: AstraZeneca

Brief Summary

This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra).

Overal Status Start Date Phase Study Type
Recruiting September 27, 2018 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Progression Free Survival (PFS)

Primary Outcome 1 - Time Frame: approximately 4 years

Primary Outcome 2 - Measure: Overall Survival (OS)

Primary Outcome 2 - Time Frame: approximately 4 years

Condition:

  • Unresectable Locally Advanced Urothelial Cancer
  • Metastatic Urothelial Cancer

Eligibility

Criteria:
Key Inclusion Criteria:

- Patients with histologically or cytologically documented, unresectable, locally
advanced or metastatic transitional cell carcinoma (transitional cell and mixed
transitional/non-transitional cell histologies) of the urothelium (including renal
pelvis, ureters, urinary bladder, and urethra)

- Patients who have not been previously treated with first-line chemotherapy. Patients
who have received prior definitive chemoradiation, adjuvant or neoadjuvant treatment
for locally advanced disease are eligible provided that progression to locally
advanced or metastatic disease has occurred >12 months from the last therapy [for
chemoradiation and adjuvant treatment] or >12 months from the last surgery [for
neoadjuvant treatment].

- At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target
lesion at baseline.

- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance
status (PS) of 0 or 1 at enrolment

- Adequate organ and marrow function as defined in the protocol

- Life expectancy ≥12 weeks in the opinion of the investigator

- Evidence of post-menopausal status, or negative urinary or serum pregnancy test for
female pre-menopausal patients.

Key Exclusion Criteria:

- Prior exposure to immune-mediated therapy (with exclusion of Bacillus Calmette
Guerin), including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD L1, or
anti-PD-L2 antibodies, except therapeutic anticancer vaccines, which are permitted.
Prior local intervesical chemotherapy or immunotherapy is allowed if completed at
least 28 days prior to the initiation of study treatment.

- No severe concomitant condition that requires immunosuppression medication

- Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis

- Patients who may be eligible for or are being considered for radical resection during
the course of the study.

- Any medical contraindications to platinum (cisplatin or carboplatin) based doublet
chemotherapy and/or known allergy or hypersensitivity to any of the study drugs or any
of the study drug excipients
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Gender: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Healthy Volunteers: No

Overall Contact

Name: AstraZeneca Clinical Study Information Center

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Locations

Facility Status Contact
Research Site
Birmingham, Alabama 35294
United States
Recruiting
Research Site
Bakersfield, California 93309
United States
Recruiting
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Fountain Valley, California 92708
United States
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Fullerton, California 92835
United States
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Los Angeles, California 90095
United States
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Salinas, California 93901
United States
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Santa Barbara, California 93105
United States
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Santa Maria, California 93454
United States
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Truckee, California 96161
United States
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New Haven, Connecticut 06520
United States
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Orlando, Florida 32806
United States
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Chicago, Illinois 60611
United States
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Fort Wayne, Indiana 46808
United States
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Kansas City, Kansas 66160
United States
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Louisville, Kentucky 40202
United States
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New Orleans, Louisiana 70112
United States
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Grand Rapids, Michigan 49503
United States
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Bozeman, Montana 59718
United States
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Livingston, New Jersey 07039
United States
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Neptune, New Jersey 07754
United States
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Bronx, New York 10467
United States
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Lake Success, New York 11042
United States
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New York, New York 10029
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New York, New York 10065
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Rochester, New York 14642
United States
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Sioux Falls, South Dakota 57104
United States
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Germantown, Tennessee 38138
United States
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Fort Worth, Texas 76104
United States
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Box Hill, 3128
Australia
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Elizabeth Vale, 5112
Australia
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Kogarah, 2217
Australia
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Macquarie University, 2109
Australia
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Murdoch, 6150
Australia
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Orange, 2800
Australia
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South Brisbane, 4101
Australia
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St Albans, 3021
Australia
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Curitiba, 80810-050
Brazil
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Fortaleza, 60336-232
Brazil
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Porto Alegre, 90020-090
Brazil
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Porto Alegre, 90610-000
Brazil
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Porto Alegre, 91350-200
Brazil
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Ribeirão Preto, 14048-900
Brazil
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Rio de Janeiro, 20231-050
Brazil
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Rio de Janeiro, 22793-080
Brazil
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Salvador, 41950-640
Brazil
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Sao Paulo, 01327-001
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São José do Rio Preto, 15090-000
Brazil
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São Paulo, 01246-000
Brazil
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Burgas, 8000
Bulgaria
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Pleven, 5800
Bulgaria
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Plovdiv, 4000
Bulgaria
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Sofia, 1303
Bulgaria
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Sofia, 1431
Bulgaria
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Sofia, 1797
Bulgaria
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Varna,
Bulgaria
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Calgary, Alberta T2N 4N2
Canada
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Edmonton, Alberta T6G 1Z2
Canada
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Vancouver, British Columbia V5Z 4E6
Canada
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Hamilton, Ontario L8V 5C2
Canada
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Ottawa, Ontario K1H 8L6
Canada
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Toronto, Ontario M5G IX6
Canada
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Montreal, Quebec H3T 1E2
Canada
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Beijing, 100034
China
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Beijing, 100191
China
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Beijing, 100730
China
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Beijing,
China
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Changchun, 130021
China
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Changsha, 410008
China
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Changsha, 410013
China
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Chongqing, 400010
China
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Chongqing, 400038
China
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Dalian, 116027
China
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Guangzhou, 510000
China
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Guangzhou, 510060
China
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Hangzhou, 310003
China
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Hangzhou, 310009
China
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Hangzhou, 310014
China
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Hangzhou, 310022
China
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Nanchang, 330006
China
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Nanjing, 2100008
China
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Nanjing, 210009
China
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Shanghai, 200032
China
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Shanghai, 200072
China
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Shanghai, 200127
China
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Shenyang, 110001
China
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Suzhou, 215006
China
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Tianjin, 300211
China
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Urumqi, 830000
China
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Xi'an, 710061
China
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Xiamen, 361003
China
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Brno, 656 91
Czechia
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Hradec Kralove, 500 05
Czechia
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Olomouc, 779 00
Czechia
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Ostrava, 708 52
Czechia
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Praha 2, 128 08
Czechia
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Praha, 140 59
Czechia
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Praha, 180 81
Czechia
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Budapest, 1062
Hungary
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Budapest, 1122
Hungary
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Budapest, 1145
Hungary
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Debrecen, 4032
Hungary
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Györ, 9024
Hungary
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Kecskemét, 6000
Hungary
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Szolnok, 5004
Hungary
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Ahmedabad, 380060
India
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Gurgaon, 122001
India
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Hubli, 580025
India
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Kolkata, 700160
India
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Nagpur, 440012
India
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New Delhi, 110063
India
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New Delhi, 110085
India
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Pune, 411004
India
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Vadodara, 390007
India
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Haifa, 31096
Israel
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Jerusalem, 91120
Israel
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Kfar Saba, 95847
Israel
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Petach-Tikva, 4941492
Israel
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Ramat Gan, 52621
Israel
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Arezzo, 52100
Italy
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Milano, 20133
Italy
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Napoli, 80131
Italy
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Orbassano, 10043
Italy
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Parma, 43100
Italy
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Pavia, 27100
Italy
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Roma, 00100
Italy
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San Giovanni Rotondo, 71013
Italy
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Terni, 05100
Italy
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Verona, 37134
Italy
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Bunkyo-ku, 113-8603
Japan
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Chuo-ku, 104-0045
Japan
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Fukuoka-shi, 811-1347
Japan
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Hirosaki-shi, 036-8563
Japan
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Kanazawa-shi, 920-8641
Japan
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Kita-gun, 761-0793
Japan
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Koshigaya-shi, 343-8555
Japan
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Koto-ku, 135-8550
Japan
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Kumamoto-shi, 860-0008
Japan
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Kumamoto-shi, 860-8556
Japan
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Kyoto-shi, 606-8507
Japan
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Miyazaki-city, 889-1692
Japan
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Nagasaki-shi, 852-8501
Japan
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Nagoya-shi, 466-8560
Japan
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Nagoya-shi, 467-0001
Japan
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Niigata-shi, 951-8520
Japan
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Osaka-shi, 541-8567
Japan
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Osaka-shi, 545-0051
Japan
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Osakasayama-shi, 589-8511
Japan
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Shinjuku-ku, 160-8582
Japan
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Suita-shi, 565-0871
Japan
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Toyama-shi, 930-0194
Japan
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Tsukuba-shi, 305-8576
Japan
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Yokohama-shi, 232-0024
Japan
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Yokohama-shi, 241-8515
Japan
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Goyang-si, 10408
Korea, Republic of
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Incheon, 21565
Korea, Republic of
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Seoul, 02841
Korea, Republic of
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Seoul, 03722
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Seoul, 05505
Korea, Republic of
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Seoul, 06351
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Suwon-si, 442-723
Korea, Republic of
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Bacolod, 6100
Philippines
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Baguio City, 2600
Philippines
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Cebu, 6000
Philippines
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Davao City, 8000
Philippines
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Makati, 1229
Philippines
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Manila, 1015
Philippines
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Quezon City, 1101
Philippines
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Quezon City, 1104
Philippines
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Bialystok, 15-027
Poland
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Gdańsk, 80-214
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Grudziądz, 86-300
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Koszalin, 75-581
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Kraków, 31-501
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Olsztyn, 10-228
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Poznan, 60-693
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Radom, 26-600
Poland
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Warszawa, 02-781
Poland
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Ivanovo, 153040
Russian Federation
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Krasnoyarsk, 660133
Russian Federation
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Moscow, 105229
Russian Federation
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Moscow, 115280
Russian Federation
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Moscow, 125284
Russian Federation
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Moscow, 125367
Russian Federation
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Nizhniy Novgorod, 603137
Russian Federation
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Omsk, 644013
Russian Federation
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Rostov-on-Don, 344037
Russian Federation
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Saint-Petersburg, 195067
Russian Federation
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St. Petersburg, 199178
Russian Federation
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St.-Petersburg,, 198205
Russian Federation
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Vologda, 160012
Russian Federation
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Barcelona, 08908
Spain
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Barcelona, 8003
Spain
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Barcelona, 8035
Spain
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Lugo, 27003
Spain
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Madrid, 28007
Spain
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Madrid, 28034
Spain
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Madrid, 28040
Spain
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Malaga, 29010
Spain
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Santander, 39008
Spain
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Sevilla, 41013
Spain
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Taichung, 404
Taiwan
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Taichung, 40705
Taiwan
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Tainan, 704
Taiwan
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Taipei City, 10050
Taiwan
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Taipei, 11217
Taiwan
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Bangkok, 10300
Thailand
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Bangkok, 10400
Thailand
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Chom Thon, 50200
Thailand
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Adana, 1260
Turkey
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Adapazari, 54290
Turkey
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Ankara, 06590
Turkey
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Edirne, 22030
Turkey
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Istanbul, 34030
Turkey
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Izmir,
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Ha Noi, 100000
Vietnam
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Hanoi, 100000
Vietnam
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Ho Chi Minh city, 700000
Vietnam
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Ho Chi Minh city,
Vietnam
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Ho Chi Minh, 700000
Vietnam
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