"Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the Apact Study)"

PHASE3CompletedINTERVENTIONAL
Enrollment

866

Participants

Timeline

Start Date

March 28, 2014

Primary Completion Date

June 30, 2022

Study Completion Date

June 30, 2022

Conditions
Pancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsPancreatic DiseasesDigestive System DiseasesEndocrine System DiseasesGemcitabineAntimetabolites, Antineoplastic
Interventions
DRUG

nab-Paclitaxel

nab-Paclitaxel 125 mg/m\^2 on Days 1, 8, and 15 of every 28 day treatment cycle by intravenous (IV) administration for a total of 6 cycles.

DRUG

Gemcitabine

Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15 of a 28 day cycle by IV administration for a total of 6 cycles.

Trial Locations (341)

0

Local Institution - 601, Hong Kong

Local Institution - 602, Shatin

4

Local Institution - 310, Dublin

St Vincent's University Hospital, Dublin

114

Local Institution - 622, Taipei

144

Istituto Nazionale Tumori Regina Elena, Roma

333

Chang Gung Medical Foundation-Linkou Branch, Taoyuan District

Local Institution - 624, Taoyuan District

704

Local Institution - 625, Tainan, Taiana

National Cheng Kung University Hospital, Tainan, Taiana

1070

Hopital Erasme, Brussels

Local Institution - 211, Brussels

1090

Local Institution - 200, Vienna

Medizinische Universitat Wien, Vienna

1097

Fovarosi Szent Istvan es Szent Laszlo Korhaz es Rendelointezet, Budapest

Local Institution - 293, Budapest

1100

Kaiser-Franz-Josef Spital, Vienna

Local Institution - 201, Vienna

1105

Academisch Medisch Centrum Amsterdam, Amsterdam

Local Institution - 400, Amsterdam

1145

Local Institution - 291, Budapest

Uzsoki Utcai Korhaz, Budapest

2010

Local Institution - 501, Darlinghurst

Saint Vincent's Hospital, Darlinghurst

2031

Local Institution - 500, Randwick

Prince of Wales Hospital, Randwick

2065

Local Institution - 507, St Leonards

Northern Cancer Institute, St Leonards

2605

Canberra Hospital, Garran

Local Institution - 505, Garran

2650

UZ Antwerpen, Edegem

2700

Hospital Wiener Neustadt, Wiener Neustadt

Local Institution - 202, Wiener Neustadt

2730

Herlev Hospital, Herlev

Local Institution - 232, Herlev

3000

Local Institution - 210, Leuven

UZ Leuven, Leuven

3084

Austin Hospital, Heidelberg

Local Institution - 509, Heidelberg

3144

Cabrini Hospital, Malvern

Local Institution - 503, Malvern

3165

Local Institution - 506, Bentleigh East

Monash Medical Centre Moorabbin Campus, Bentleigh East

4010

Hospital of Elisabethinen Linz, Linz

Local Institution - 206, Linz

4029

Local Institution - 504, Herston

Royal Brisbane and Women's Hospital, Herston

4032

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Debrecen

Local Institution - 290, Debrecen

4064

ICON Cancer Center, Milton

Local Institution - 502, Milton

4200

Hospital de Sao Joao, Porto

Local Institution - 342, Porto

4600

Klinikum Wels-Grieskirchen GmbH, Wels

Local Institution - 0207, Wels

5000

Local Institution - 230, Odense C

Onk.Dep., Odense Universitets hospital, Odense C

5004

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok

5011

The Queen Elizabeth Hospital, Woodville South

5020

Local Institution - 204, Salzburg

Salzburger Landkliniken St. Johanns-Spital, Salzburg

6008

Local Institution - 508, Subiaco

St John of God Subiaco Hospital, Subiaco

6020

Local Institution - 203, Innsbruck

Medical University Innsbruck, Innsbruck

6720

Local Institution - 295, Szeged

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szent-Gyorgyi Albert TE AOK Borgyogy, Szeged

8011

Isala Klinieken, Zwolle

Local Institution - 402, Zwolle

8035

Hospital Universitari Vall d'Hebron, Barcelona

8036

Local Institution - 205, Graz

9000

Local Institution - 213, Ghent

UZ Gent, Ghent

Hæmatologisk afd. B Aalborg Sygehus Syd, Aalborg

Local Institution - 231, Aalborg

9024

Local Institution - 292, Győr

Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat, Győr

9411

University of California, San Francisco Cutaneous Oncology and Melanoma Center, San Francisco

10002

Local Institution - 621, Tapei

National Taiwan University Hospital, Tapei

10032

Columbia University Medical Center, New York

Local Institution - 032, New York

10591

MSKCC at Phelps Memorial Hospital Center. Phelps Sleepy Hollow, Sleepy Hollow

10604

Memorial Sloan Kettering Cancer Center West Harrison, Harrison

11042

NYU Langone Medical Center, Lake Success

11217

Local Institution - 623, Taipei

Taipei Veterans General Hospital, Taipei

11490

Tri-Service General Hospital, Taipei

11570

Local Institution - 066, Rockville Centre

MSKCC at Mercy Medical Center Mercy RockvilleCenter, Rockville Centre

11725

Memorial Sloan-Kettering Cancer Center, Commack

12203

Charite - Universitätsmedizin Berlin, Berlin

Local Institution - 272, Berlin

13215

State University of New York Upstate Medical Center, Syracuse

14263

Local Institution - 025, Buffalo

Roswell Park Cancer Institute, Buffalo

14642

Local Institution - 013, Rochester

University of Rochester Cancer Center, James P. Wilmot Cancer Center, Rochester

15232

Local Institution - 027, Pittsburgh

UPMC Cancer Pavillion, Pittsburgh

15706

Hospital Clinico Universitario De Santiago De Compostela, Santiago de Compostela

Local Institution - 366, Santiago de Compostela

17487

Ernst-Moritz-Arndt-Universität Greifswald, Greifswald

Local Institution - 279, Greifswald

19107

Local Institution - 016, Philadelphia

Thomas Jefferson University, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

20089

Istituto Clinico Humanitas, Rozzano (MI)

Local Institution - 326, Rozzano (MI)

20132

Local Institution - 321, Milan

Ospedale San Raffaele S.r.l., Milan

20162

Azienda Ospedaliera Niguarda Ca Granda, Milan

Local Institution - 322, Milan

20246

Local Institution - 273, Hamburg

Universitaetsklinik Hamburg - Eppendorf, Hamburg

20521

Local Institution - 242, Turku

Turku University Hospital, Turku

22908

Local Institution - 038, Charlottesville

University of Virginia, Charlottesville

28007

Hospital General Gregorio Maranon, Madrid

Local Institution - 367, Madrid

28034

Local Institution - 362, Madrid

Ramon y Cajal Univeresity Hospital, Madrid

28040

Hospital Clinico San Carlos, Madrid

Local Institution - 372, Madrid

28041

Hospital 12 de Octubre, Madrid

Local Institution - 365, Madrid

28050

Centro Integral, Madrid

Local Institution - 361, Madrid

29010

Hospital General Carlos Haya, Málaga

Local Institution - 369, Málaga

30341

Georgia Cancer Specialist, Atlanta

31008

Complejo Hospitalario de Navarra, Pamplona/ Navarra

Local Institution - 368, Pamplona/ Navarra

31059

Local Institution - 256, Toulose

Pole Des Specialites Medicales, Hopital Purpan, Toulose

32207

H Lee Moffitt Cancer Center, Tampa

32605

Gainesville Heme Oncology Associates, Gainesville

32610

Local Institution - 011, Gainesville

University of Florida, Gainesville

32804

Florida Hospital Cancer Institute, Orlando

Local Institution - 039, Orlando

33136

University of Miami and Sylvester Cancer Center, Miami

33486

Local Institution - 022, Boca Raton

Lynn Cancer Institute, Boca Raton

33521

Tampereen yliopistollinen sairaala, Tampere

33916

Florida Cancer Institute Cancer Spec, Fort Myers

Local Institution - 031, Fort Myers

37134

Azienda Ospedaliera Universitaria Integrata di Verona, Verona

Local Institution - 320, Verona

37203

Local Institution - 004, Nashville

Sarah Cannon Research Inst, Nashville

37404

Chattanooga Oncology Hematology Care, Chattanooga

Local Institution - 023, Chattanooga

39008

Local Institution - 371, Santander

Hospital Universitario Marques de Valdecilla, Santander

39108

Local Institution - 274, Magdeburg

Universitatsklinik Magdeburg, Magdeburg

40138

Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi, Bologna

Local Institution - 330, Bologna

40202

University of Louisville, Louisville

40705

Local Institution - 620, Taichung

Taichung Veterans General Hospital, Taichung

41013

Hospital Virgen del Rocio, Seville

Local Institution - 364, Seville

42100

Arcispedale Santa Maria Nuova, Reggio Emilia

Local Institution - 333, Reggio Emilia

43210

Local Institution - 005, Columbus

Ohio State University Medical Center, Columbus

44106

Case Western Reserve Center, Cleveland

Local Institution - 047, Cleveland

44195

Cleveland Clinic - Taussig Cancer Institute, Cleveland

Cleveland Clinic Foundation IRB, Cleveland

Cleveland Clinic Foundation, Cleveland

Local Institution - 020, Cleveland

Local Institution - 054, Cleveland

45136

Kliniken Essen-Mitte, Essen

45242

Local Institution - 030, Cincinnati

Oncology Hematology Care, Inc., Cincinnati

47014

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.), Meldola

Local Institution - 331, Meldola

48109

Local Institution - 036, Ann Arbor

University of Michigan, Ann Arbor

48201

Karmanos Cancer Center Wayne State University, Detroit

49033

Center Hospitalier Universitaire d' Angers, Angers

Local Institution - 253, Angers

50134

Azienda Ospedaliero-Universitaria Careggi, Florence

Local Institution - 328, Florence

50226

Local Institution - 284, Frechen

Praxis Internistischer Onkologie und Hamatologie Frechen, Frechen

50674

Local Institution - 281, Cologne

Praxis Internistischer Onkologie und Hamatologie Koln, Cologne

53792

Local Institution - 014, Madison

University of Wisconsin - Madison Cancer Center, Madison

55131

Klinikum der Johannes Gutenberg Uniervsitaet ,Haematologie, Mainz

Local Institution - 283, Mainz

55905

Local Institution - 021, Rochester

Mayo Clinic, Rochester

56126

Azienda Ospedaliero-Universitaria Pisana, Pisa

Local Institution - 324, Pisa

59037

CHRU de Lille France, Lille

Local Institution - 257, Lille

60020

Local Institution - 325, Ancona

Ospedali Riuniti Umberto I GM Lancisi, Ancona

60201

Northshore University Healthsystem Research Institute, Evanston

60590

Local Institution - 277, Frankfurt

Universitatsklinkum Frankfurt, Frankfurt

60637

University of Chicago Medical Center, Chicago

60714

Illinois Cancer Specialists, Niles

68114

Local Institution - 048, Omaha

Nebraska Methodist Hospital, Omaha

69008

Hopital prive Jean Mermoz, Lyon

Local Institution - 252, Lyon

69437

Hopital Edouard Herriot - Hepato-gastroenterologie, Lyon

Local Institution - 258, Lyon

71013

IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo

Local Institution - 332, San Giovanni Rotondo

72076

Local Institution - 0271, Tübingen

University of Tubingen, Tübingen

73104

Local Institution - 049, Oklahoma City

University of Oklahoma Peggy and Charles Stephenson Cancer Center, Oklahoma City

75015

Hopital Europeen Georges Pompidou, Paris

Local Institution - 250, Paris

75230

Texas Oncology, Dallas

75246

Baylor Sammons Cancer Center, Dallas

Local Institution - 062, Dallas

75390

Local Institution - 010, Dallas

UT Southwestern Medical Center, Dallas

75571

Hopital Saint Antoine, Paris

75651

Hopital Pitie Salpetriere, Paris

Local Institution - 259, Paris

75702

Texas Oncology, P.A. - Tyler, Tyler

76104

Local Institution - 050, Fort Worth

The Center for Cancer and Blood Disorders - Fort Worth, Fort Worth

77030

Baylor College of Medicine, Houston

Local Institution - 041, Houston

80045

University of Colorado Cancer Center, Aurora

80218

Local Institution - 059, Denver

Rocky Mountain Cancer Centers, LLP [Denver-Midtown], Denver

81377

Klinikum der Universitat Munchen-Grosshadern, München

Local Institution - 282, München

81737

Klinikum Neuperlach, München

Local Institution - 276, München

85259

Local Institution - 043, Scottsdale

Mayo Clinic - Arizona, Scottsdale

86021

CHU La Miletrie, Poitiers

Local Institution - 251, Poitiers

88045

Local Institution - 275, Friedrichshafen

Praxis für Innere Medizin, Dr.Oettle Helmut, Friedrichshafen

90033

University of Southern California, Los Angeles

90404

University of California Los Angeles, Santa Monica

92093

UCSD Moores Cancer Center, La Jolla

92637

Klinikum Weiden, Bayern

Local Institution - 280, Bayern

94010

Hopital Henri Mondor, Créteil

94110

Local Institution - 001, San Francisco

95817

Local Institution - 044, Sacramento

UC Davis Cancer Center, Sacramento

97080

Local Institution - 270, Würzburg

Universitatsklinikum Würzburg, Würzburg

97239

Local Institution - 019, Portland

Oregon Health and Science University OHSU, Portland

98109

Local Institution - 003, Seattle

Seattle Cancer Care Alliance - Seattle, Seattle

98111

Virginia Mason Cancer Center, Seattle

119074

Local Institution - 610, Singapore

National University Hospital, Singapore

06510

Yale Cancer Center, New Haven

70121-2483

Ochsner Clinic Foundation, New Orleans

Ochsner Medical Center - Jefferson Highway, New Orleans

02114

Massachusetts General Hospital, Boston

02115

Beth Israel-Deaconess Medical Center, Boston

Local Institution - 040, Boston

02215

Dana Farber Cancer Institute, Boston

Local Institution - 045, Boston

07920

Local Institution - 064, Basking Ridge

MSKCC Basking Ridge, Basking Ridge

07039

Saint Barnabas Medical Center, Livingston

10021-6007

Local Institution - 008, New York

Memorial Sloan-Kettering Cancer Center - NYC, New York

27157-1082

Local Institution - 051, Winston-Salem

Wake Forest Univ. Health Sciences Outpatient Comprehensive Cancer Center, Winston-Salem

45267-0501

University of Cincinnati Medical CenterDivsion of Hematology OncologyThe Barrett Center, Cincinnati

37232-6307

Local Institution - 002, Nashville

Vanderbilt- Ingram Cancer Center, Nashville

A-8036

Medical University of Graz, Graz

T2N 4N2

Local Institution - 102, Calgary

Tom Baker Cancer Center, Calgary

M4N 3M5

Local Institution - 101, Toronto

Sunnybrook Health Sciences Centre, Toronto

M5G 2M9

Local Institution - 100, Toronto

Princess Margaret Hospital, Toronto

H2X 3J4

Centre Hospitalier de L'Universite de Montreal St-Luc, Montreal

Local Institution - 104, Montreal

H3T 1E2

Jewish General Hospital, Montreal

Local Institution - 103, Montreal

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

Local Institution - 220, Hradec Králové

460 63

Krajska nemocnice Liberec, a.s., Liberec

762 75

Krajska nemocnice T. Bati a.s., Zlín

Local Institution - 221, Zlín

FI-33520

Local Institution - 240, Tampere

FI-00290

Helsingin yliopistollinen keskussairaala, Helsinki

Local Institution - 241, Helsinki

D-01307

Local Institution - 278, Dresden

Universitatsklinikum Carl Gustav Carus an der TU Dresden, Dresden

Unknown

Queen Mary Hospital, Hong Kong

Tuen Mun Hospital, Hong Kong

Prince of Wales Hospital the Chinese University of Hong Kong, Shatin

Cork University Hospital, Cork

T12 DFK4

Local Institution - 311, Cork

05100

Local Institution - 329, Terni

Azienda Ospedaliera S Maria di Terni, Terni

00144

Local Institution - 323, Roma

00168

Local Institution - 327, Roma

Policlinico Universitario Agostino Gemelli, Roma

5632 EJ

Catharina Hospital, Eindhoven

Local Institution - 403, Eindhoven

1069-639

Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos, Lisbon

Local Institution - 340, Lisbon

1500-650

Hospital Da Luz, Lisbon

Local Institution - 341, Lisbon

169-610

Local Institution - 611, Singapore

National Cancer Center, Singapore

03080

Local Institution - 641, Seoul

Seoul National University Hospital, Seoul

135-710

Local Institution - 642, Seoul

Samsung Medical Center, Seoul

138-736

Asan Medical Center, Seoul

Local Institution - 640, Seoul

08035

Local Institution - 360, Barcelona

08036

Clinic Barcelona Hospital Universitari, Barcelona

Local Institution - 363, Barcelona

08907

Instituto Catalan de Oncologia-Hospital Duran, Barcelona

Local Institution - 370, Barcelona

CB2 0QQ

Addenbrookes Hospital, Cambridge

Local Institution - 382, Cambridge

G11 6NT

Glasgow Royal Infirmary, Glasgow

Local Institution - 380, Glasgow

S10 2SJ

Local Institution - 381, Sheffield

S10 2SS

Weston Park Hospital, Sheffield South Yorkshire

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY