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ACTIVE NOT RECRUITING
NCT03732677
PHASE3

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer

Official title: A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients With Muscle-Invasive Bladder Cancer.

Key Details

Gender

All

Age Range

18 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

1063

Start Date

2018-11-16

Completion Date

2026-06-30

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

Durvalumab

Anti- PD-L1 Antibody

DRUG

Cisplatin

Chemotherapy Agent

DRUG

Gemcitabine

Chemotherapy agent

Locations (188)

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Birmingham, Alabama, United States

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Los Angeles, California, United States

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Palo Alto, California, United States

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New Haven, Connecticut, United States

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Chicago, Illinois, United States

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Geneva, Illinois, United States

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Iowa City, Iowa, United States

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Westwood, Kansas, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Towson, Maryland, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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New York, New York, United States

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Rochester, New York, United States

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Bethlehem, Pennsylvania, United States

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Burlington, Vermont, United States

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Milwaukee, Wisconsin, United States

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Brisbane, Australia

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Elizabeth Vale, Australia

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Macquarie University, Australia

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Melbourne, Australia

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Murdoch, Australia

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South Brisbane, Australia

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Bruges, Belgium

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Charleroi, Belgium

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Kortrijk, Belgium

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Leuven, Belgium

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Liège, Belgium

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Roeselare, Belgium

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Barretos, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Rio de Janeiro, Brazil

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Santa Maria, Brazil

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São José do Rio Preto, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Antofagasta, Chile

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Port Montt, Chile

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Santiago, Chile

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Temuco, Chile

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Temuco, Chile

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Viña del Mar, Chile

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Brno, Czechia

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Brno, Czechia

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Hradec Králové, Czechia

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Olomouc, Czechia

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Prague, Czechia

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Prague, Czechia

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Prague, Czechia

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Angers, France

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Dijon, France

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Grenoble, France

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Montpellier, France

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Nîmes, France

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Pierre-Bénite, France

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Poitiers, France

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Rouen, France

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Bergisch Gladbach, Germany

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Bonn, Germany

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Cologne, Germany

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Erlangen, Germany

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Göttingen, Germany

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Herne, Germany

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Jena, Germany

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Magdeburg, Germany

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Mannheim, Germany

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Münster, Germany

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Nuremberg, Germany

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Oldenburg, Germany

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Regensburg, Germany

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Ulm, Germany

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Würzburg, Germany

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Haifa, Israel

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Jerusalem, Israel

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Kfar Saba, Israel

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Petah Tikva, Israel

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Ramat Gan, Israel

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Bari, Italy

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Bologna, Italy

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Florence, Italy

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Milan, Italy

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Milan, Italy

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Naples, Italy

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Orbassano, Italy

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Pozzuoli, Italy

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Verona, Italy

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Bunkyō City, Japan

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Fukuoka, Japan

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Fukuoka, Japan

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Hirosaki-shi, Japan

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Hiroshima, Japan

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Kanazawa, Japan

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Kōtoku, Japan

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Kumamoto, Japan

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Miyazaki, Japan

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Nagasaki, Japan

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Nagoya, Japan

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Niigata, Japan

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Osaka, Japan

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Osaka, Japan

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Osakasayama-shi, Japan

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Sendai, Japan

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Toyama, Japan

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Tsukuba, Japan

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Yokohama, Japan

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Yokohama, Japan

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Amsterdam, Netherlands

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Amsterdam, Netherlands

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Breda, Netherlands

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Rotterdam, Netherlands

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Baguio City, Philippines

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Cebu, Philippines

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Davao City, Philippines

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Makati, Philippines

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Manila, Philippines

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Quezon City, Philippines

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Quezon City, Philippines

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Bialystok, Poland

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Gdansk, Poland

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Grudziądz, Poland

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Koszalin, Poland

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Krakow, Poland

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Olsztyn, Poland

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Ostrołęka, Poland

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Poznan, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Krasnoyarsk, Russia

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Moscow, Russia

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Nizhny Novgorod, Russia

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Novosibirsk, Russia

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Saint Petersburg, Russia

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Saint Petersburg, Russia

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Saint Petersburg, Russia

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Saint Petersburg, Russia

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Samara, Russia

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Ufa, Russia

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Vologda, Russia

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Daegu, South Korea

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Goyang-si, South Korea

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Gyeonggi-do, South Korea

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Incheon, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Badalona, Spain

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Barcelona, Spain

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Córdoba, Spain

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Las Palmas de Gran Canaria, Spain

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Madrid, Spain

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Madrid, Spain

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Santander, Spain

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Seville, Spain

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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Ankara, Turkey (Türkiye)

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Cordaleo, Turkey (Türkiye)

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Edirne, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Edinburgh, United Kingdom

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London, United Kingdom

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Metropolitan Borough of Wirral, United Kingdom

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Nottingham, United Kingdom

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Sheffield, United Kingdom

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Hanoi, Vietnam

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Ho Chi Minh City, Vietnam

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Hochiminh, Vietnam