A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer

An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Fluorouracil/Leucovorin as Adjuvant Therapy for Patients Who Have Undergone Surgery for Colon Carcinoma, AJCC/UICC Stage III (Dukes Stage C)

This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Leucovorin (LV); Drug: 5-Fluorouracil (5-FU); Drug: Capecitabine; Drug: Oxaliplatin

• Study Type: Interventional
• Enrollment (Actual): 1886
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital; Medical Oncology
    • Port Macquarie, New South Wales, Australia, 2444
      • Port Macquarie Base Hospital; Oncology
    • Wollongong, New South Wales, Australia, 2500
      • Southern Medical Day Care; Clinical Trials Unit
  • South Australia
    • Woodville South, South Australia, Australia, 5011
      • Queen Elizabeth Hospital; Medical Oncology
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital; Oncology
    • Footscray, Victoria, Australia, 3011
      • Footscray Hospital
  • Western Australia
    • Perth, Western Australia, Australia, 6008
      • St John of God Hospital; Medical Oncology
• Belgium
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires St-Luc
  • Charleroi, Belgium, 6000
    • GHdC Site Notre Dame
  • Gent, Belgium, 9000
    • UZ Gent
  • Kortrijk, Belgium, 8500
    • Az Groeninge
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
• Brazil
  • MG
    • Belo Horizonte, MG, Brazil, 30285-000
      • Hospital de Baleia; Serviço de Oncologia Clínica
  • SP
    • Jau, SP, Brazil, 17210-120
      • Hospital Amaral Carvalho
    • Sao Paulo, SP, Brazil, 05403-000
      • Hospital das Clinicas - FMUSP; Gastroenterologia
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Centre; Dept of Medicine
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute ; Dept of Medical Oncology
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 5L3
      • Bcca - Cancer Center Southern Interior
    • Surrey, British Columbia, Canada, V3V 1Z2
      • BCCA-Fraser Valley Cancer Centre
    • Victoria, British Columbia, Canada, V8R 6V5
      • Bcca - Vancouver Island Cancer Centre; Oncology
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface General Hospital
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Dr. H. Bliss Murphy Cancer Centre; Oncology
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Queen Elizabeth II Health Sciences Centre; Oncology
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Hamilton Health Sciences - Juravinski Cancer Centre
    • London, Ontario, Canada, N6A 4L6
      • London Regional Cancer Centre
    • Mississauga, Ontario, Canada, L5M 2N1
      • Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
    • Oshawa, Ontario, Canada, L1G 2B9
      • Lakeridge Health Oshawa; Oncology
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital Cancer Centre; Oncology
    • Toronto, Ontario, Canada, M3M 0B2
      • Humber River Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Science Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network; Princess Margaret Hospital; Medical Oncology Dept
  • Quebec
    • Laval, Quebec, Canada, H7M 3L9
      • Cite de La Sante de Laval; Hemato-Oncologie
    • Levis, Quebec, Canada, G6V 3Z1
      • Hotel Dieu de Levis; Oncology
    • Montreal, Quebec, Canada, H1T 2M4
      • Hopital Maisonneuve- Rosemont; Oncology
    • Montreal, Quebec, Canada, H3T 1E2
      • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
    • Montreal, Quebec, Canada, H2X 0A9
      • Chum Campus Notre Dame
    • Montreal, Quebec, Canada, H4J 1C5
      • Hopital Du Sacre Coeur de Montreal; Pneumologie
    • Quebec City, Quebec, Canada, G1R 2J6
      • Chuq - Hopital Hotel Dieu de Quebec; Oncology
• China
  • Beijing, China, 100021
    • Cancer Hospital Chinese Academy of Medical Sciences.
  • Guangzhou, China, 510515
    • Nanfang Hospital, Southern Medical University
  • Hangzhou, China, 310009
    • The Second Affiliated Hospital of Zhejiang University College
  • Nanchang, China, 330006
    • The 1st Affiliated Hospital of Nanchang Unversity
  • Nanjing, China, 210009
    • Jiangsu Cancer Hospital
  • Shandong, China, 250117
    • Shandong Cancer Hospital; Oncology
  • Shanghai, China, 200025
    • Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
  • Shanghai, China, 200092
    • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Shanghai City, China, 200120
    • Fudan University Shanghai Cancer Center
  • Tianjin, China, 300060
    • Tianjin cancer hospital
  • Wuhan, China, 430030
    • Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
• Finland
  • Tampere, Finland, 33520
    • Tampere University Hospital; Dept of Oncology
  • Turku, Finland, 20520
    • Turku Uni Central Hospital; Oncology Clinics
• France
  • Colmar, France, 68024
    • Hopital Louis Pasteur; Medecine B
  • Lille, France, 59037
    • Hopital Claude Huriez; Medecine Interne Oncologie
  • Marseille, France, 13273
    • Institut Paoli Calmettes; Oncologie Medicale
  • Strasbourg, France, 67091
    • Hopital Civil; Hematologie Oncologie
• Germany
  • Freiburg, Germany, 79110
    • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
  • Halle, Germany, 06120
    • Universitaetsklinikum Halle; Klinik u.Poliklinik fuer Innere Medizin IV
  • Magdeburg, Germany, 39130
    • Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie
  • Trier, Germany, 54290
    • Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
• Greece
  • Athens, Greece, 10676
    • Evangelismos Hospital; Medical Oncology
  • Athens, Greece, 11527
    • Per. Gen. Hospital Ippokrateion; Oncology Dept.
  • Heraklion, Greece, 711 10
    • Univ General Hosp Heraklion; Medical Oncology
  • Patras, Greece, 265 04
    • University Hospital of Patras Medical Oncology
  • Thessaloniki, Greece, 546 39
    • Theagenio Anticancer Hospital; 3Rd Oncology Clinic
  • Thessaloniki, Greece, 56439
    • Theageneio Anticancer Hospital; Gastroenterology
• Hong Kong
  • Hong Kong, Hong Kong, 852
    • Queen Mary Hospital; Surgery
• Hungary
  • Budapest, Hungary, 1051
    • Ogyi, Orszagos Gyogyszereszeti Intezet
  • Budapest, Hungary, 1097
    • Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X
  • Budapest, Hungary, 1122
    • Orszagos Onkologial Intezet; Onkologiai Osztaly X
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
• Ireland
  • Cork, Ireland
    • Mercy Uni Hospital; Deparment of Medical Oncology
  • Dublin, Ireland, 8
    • St. James Hospital; Oncology
  • Galway, Ireland
    • Galway Uni Hospital; Oncology Dept
• Israel
  • Beer Sheva, Israel, 8410100
    • Soroka Medical Center; Oncology Dept
  • Haifa, Israel, 3109601
    • Rambam Medical Center; Oncology
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center; Oncology Dept
  • Jerusalem, Israel, 9112000
    • Hadassah Ein Karem Hospital; Oncology Dept
  • Kfar-Saba, Israel, 4428164
    • Meir Medical Center; Oncology
  • Nahariya, Israel, 22100
    • Nahariya Hospital; Oncology
  • Petach Tikva, Israel, 4941492
    • Rabin Medical Center; Oncology Dept
  • Petach Tikva, Israel
    • Golda Hasharon Medical Center; Oncology
  • Ramat Gan, Israel, 52620-00
    • Chaim Sheba Medical Center; Oncology Dept
  • Rehovot, Israel, 7610001
    • Kaplan Medical Center; Oncology Inst.
  • Tel Aviv, Israel, 64239-06
    • Sourasky / Ichilov Hospital; Oncology Department
  • Zerifin, Israel, 6093000
    • Assaf Harofeh; Oncology
• Italy
  • Emilia-Romagna
    • Cattolica, Emilia-Romagna, Italy, 47841
      • Ospedale Cervesi di Cattolica; ONCOLOGIA
    • Parma, Emilia-Romagna, Italy, 43100
      • Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
    • Rimini, Emilia-Romagna, Italy, 47900
      • Ospedale Degli Infermi; Divisione Di Oncologia
  • Friuli-Venezia Giulia
    • Udine, Friuli-Venezia Giulia, Italy, 33100
      • Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
  • Liguria
    • Genova, Liguria, Italy, 16132
      • Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical
  • Lombardia
    • Bergamo, Lombardia, Italy, 24127
      • Asst Papa Giovanni XXIII; Oncologia Medica
    • Milano, Lombardia, Italy, 20141
      • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
  • Marche
    • Ancona, Marche, Italy, 60121
      • A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica
  • Sardegna
    • Sassari, Sardegna, Italy, 07100
      • Ospedale Civile; Oncologia Medica
  • Toscana
    • Livorno, Toscana, Italy, 57100
      • Ospedale Civile; Unita Operativa Di Oncologia Medica
    • Poggibonsi, Toscana, Italy, 53036
      • Azienda Usl 7; Dept. Oncologico
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Centre; Division of Hematology/Oncology
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
  • Seoul, Korea, Republic of, 03722
    • Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology
  • Seoul, Korea, Republic of, 133-792
    • Hanyang Uni Hospital; Dept. of Internal Medicine , Section of Hemato-Oncology
• Mexico
  • Chihuahua, Mexico, 31000
    • Centro Estatal de Cancerologia
  • Chihuahua, Mexico, 31000
    • Hospital Christus Muguerza Del Parque; Centro de Rehabilitacion
  • Mexicali, Mexico, 21100
    • Clinica de Especialidades # 30 Dr. Humberto Torres Sangines; Oncology
  • Mexico City, Mexico, 14000
    • Instituto Nacional De Ciencias Medicas Y Nutricion; Nefrology
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
  • Christchurch, New Zealand
    • Christchurch Hospital; Dept of Oncology
  • Dunedin, New Zealand, 9016
    • Dunedin Hospital; Oncology - Haematology Clinical Practice Group
  • Palmerston North, New Zealand, 4442
    • Palmerston North Hospital; Regional Cancer Treatment Service
  • Wellington, New Zealand, 6002
    • Wellington Hospital; Regional Oncology Unit
• Panama
  • Panama City, Panama
    • Isthmian Medical Research Center, S.A.; Oncology
• Poland
  • Krakow, Poland, 31-826
    • Rydygiera Hospital; Chemotherapy
  • Lodz, Poland, 93-509
    • Wojewodzki Szpital Specjalistyczny Im. M. Kopernika; Oddzial Chorob Rozrostowych
  • Poznan, Poland, 61-866
    • Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii
  • Szczecin, Poland, 71-730
    • Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
  • Warszawa, Poland, 02-781
    • Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Klinika Nowotworow Jelita Grubego
  • Zielona Gora, Poland, 65-046
    • Lubuski Osrodek Onkologii, Szpital Wojewodzki; Oddzial Onkologii
• Portugal
  • Beja, Portugal, 7801-849
    • Hospital Jose Joaquim Fernandes; Unidade de Oncologia Medica
  • Lisboa, Portugal, 1649-035
    • Hospital de Santa Maria; Servico de Oncologia Medica
  • Porto, Portugal, 4200-072
    • IPO do Porto; Servico de Oncologia Medica
• Russian Federation
  • Moscow, Russian Federation, 115478
    • Blokhin Cancer Research Center; Combined Treatment
  • Moscow, Russian Federation, 105229
    • N.N.Burdenko Main Military Clinical Hospital; Chemotherapy
  • St Petersburg, Russian Federation, 197758
    • Petrov Research Inst. of Oncology; Dept of Bio-Therapy & Transplantation of Bone Marrow
  • St Petersburg, Russian Federation, 198255
    • St. Petersburg City Clinical Oncological Dispensary; Colorectal (Department 4)
• Singapore
  • Singapore, Singapore, 119228
    • National University Hospital; National University Cancer Institute, Singapore (NCIS)
  • Singapore, Singapore, 169610
    • National Cancer Centre; Medical Oncology
• South Africa
  • Cape Town, South Africa, 7500
    • Panorama Medical Clinic; Oncology Unit
  • Durban, South Africa, 4001
    • Hopelands Cancer Centre; Oncology
  • Pietermaritzburg, South Africa, 3201
    • Hopelands Cancer Centre ST. ANNES HOSPITAL; DEPT. OF ONCOLOGY
  • Pretoria, South Africa, 0001
    • Little Company of Mary Hospital; Mary Potter Oncology Centre
  • Sandton, South Africa, 2196
    • Sandton Oncology Medical Group
• Spain
  • Barcelona, Spain, 08035
    • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • Barcelona, Spain, 08907
    • Hospital Duran i Reynals; Oncologia
  • Barcelona, Spain, 08036
    • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  • Jaen, Spain, 23007
    • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa; Servicio de Oncologia
  • Madrid, Spain, 28040
    • Hospital Universitario Clínico San Carlos; Servicio de Oncologia
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz; Servicio de Oncologia
  • Malaga, Spain, 29010
    • Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
  • Valencia, Spain, 46009
    • Instituto Valenciano Oncologia; Oncologia Medica
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
  • Valencia, Spain, 46026
    • Hospital Universitario la Fe; Servicio de Oncologia
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital General Universitario de Elche; Servicio de Oncologia
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
      • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Islas Baleares
    • Palma De Mallorca, Islas Baleares, Spain, 07014
      • Hospital Universitario Son Espases
  • Madrid
    • Leganes, Madrid, Spain, 28911
      • Hospital Severo Ochoa; Servicio de Oncologia
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro; Servicio de Oncologia
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48903
      • Hospital de Cruces; Servicio de Oncologia
• Switzerland
  • Basel, Switzerland, 4031
    • Universitaetsspital Basel; Onkologie
• Taiwan
  • Taipei, Taiwan
    • Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery
  • Taipei City, Taiwan, 11259
    • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
  • Taoyuan, Taiwan, 333
    • Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery
• Thailand
  • Bangkok, Thailand, 10400
    • Pramongkutklao Hospital; Medicine - Medical Oncology Unit
  • Bangkok, Thailand, 10700
    • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
  • Bangkok, Thailand, 10110
    • Bumrungrad Hospital Foundation; Horizon Centre
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital; Medical Oncology Unit
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZN
    • Aberdeen Royal Infirmary; Medical Oncology Dept
  • Brighton, United Kingdom, BN2 5BE
    • The Royal Sussex County Hospital; the Sussex Cancer Centre
  • Bury St Edmunds, United Kingdom, IP33 2QZ
    • West Suffolk Hospital Nhs Trust; Gi Corridor
  • Cambridge, United Kingdom, CB2 2QH
    • Addenbrooke'S Hospital; Univ.Dept.& Mrc Unit of Clin.Oncology & Radiotherapeutics
  • Derby, United Kingdom, DE1 2QY
    • Derbyshire Royal Infirmary; Dept of Oncology
  • Glasgow, United Kingdom, G12 0YN
    • Cruk Clinical Trials Unit; Level 0 Beatson West Of Scotland Cancer Ctr
  • Guildford, United Kingdom, GU2 7XX
    • Royal Surrey County Hospital; St. Lukes Cancer Centre
  • Leeds, United Kingdom, LS9 7TF
    • St James Institute of Oncology
  • Leicester, United Kingdom, LE1 5WW
    • Leicester Royal Infirmary; Dept. of Medical Oncology
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital; Medical Oncology.
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Nhs Trust; Consultant Cancer Physician
  • London, United Kingdom, SE1 7EH
    • St Thomas Hospital; Oncology Dept
  • London, United Kingdom, W12 OHS
    • Hammersmith Hospital; Mrc Clinical Science Centre
  • Maidstone, United Kingdom, ME16 9QQ
    • Maidstone Hospital
  • Manchester, United Kingdom, M20 4QL
    • Christie Hospital; Breast Cancer Research Office
  • Middlesborough, United Kingdom, TS4 3BW
    • James Cook Uni Hospital
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • Northern Centre for Cancer Care;Oncology
  • Northwood, United Kingdom, HA6 2RN
    • Mount Vernon Hospital; Centre For Cancer Treatment
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham City Hospital; Oncology
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford Hospital; Plymouth Oncology Centre
  • Rhyl, United Kingdom, LL18 5UJ
    • North Wales Cancer Treatment Centre, Glan Clwyd Hospital
  • Salisbury, United Kingdom, SP2 8BJ
    • Salisbury District General Hospital; Medical Oncology Dept
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital; Somers Cancer Research Building
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Hospital; Dept of Medical Oncology
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • The Cancer Center At Providence Park
  • California
    • Alhambra, California, United States, 91801
      • Central Hematology Oncology Medical Group Inc.
    • Bakersfield, California, United States, 93309
      • Comprehensive Blood/Cancer Ctr
    • Fullerton, California, United States, 92835
      • Virginia K. Crossen Cancer Center
    • Long Beach, California, United States, 90813
      • Pacific Shores Medical Group
    • Northridge, California, United States, 91325
      • West Valley Hematology Oncology The Thomas and Dorothy Leavey Cancer Center
    • Oxnard, California, United States, 93030
      • Ventura County Hematology-Oncology Specialists
    • Pomona, California, United States, 91767
      • Wilshire Oncology Medical Group
    • Sacramento, California, United States, 95816
      • Sutter Cancer center
    • San Diego, California, United States, 92121
      • Scripps Cancer Center
    • San Diego, California, United States, 92154
      • Kaiser Permanente San Diego; Hepatology Research
    • Santa Barbara, California, United States, 93105
      • Santa Barbara Hematology Oncology Medical Group, Inc.
    • Vista, California, United States, 92083
      • San Diego Cancer Center'S Medical Group
    • Whittier, California, United States, 90603
      • Innovative clinical research institute/American institute of research
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Health Science Center; Biomedical Research Bldg. Room 511
    • Fort Collins, Colorado, United States, 80528
      • Hematology Oncology Associates
  • Connecticut
    • Stamford, Connecticut, United States, 06902
      • Hematology Oncology P.C.
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown Uni Medical Center; Lombardi Cancer Center
  • Florida
    • Lakeland, Florida, United States, 33804-1057
      • Lakeland Regional Cancer Center
    • Miami, Florida, United States, 33136
      • Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30341
      • Georgia Cancer Specialists
  • Illinois
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care
  • Indiana
    • Terre Haute, Indiana, United States, 47802
      • Hope Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Cancer Inst.
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Park Nicollet Clinic Cancer Center
  • Missouri
    • Saint Joseph, Missouri, United States, 64507
      • St Joseph Oncology
    • Saint Louis, Missouri, United States, 63136
      • Hematology Oncology Consultants, Inc.
  • Montana
    • Billings, Montana, United States, 59101
      • Hematology-Oncology Centers of the Northern Rockies
    • Great Falls, Montana, United States, 59405
      • Great Falls Clinic
  • Nevada
    • Reno, Nevada, United States, 89502
      • VA Medical Center
  • New Hampshire
    • Hooksett, New Hampshire, United States, 03106
      • Nh Oncology Hematology, Pa
  • New Jersey
    • Morristown, New Jersey, United States, 07962
      • Morristown Medical Center;Hematology-Oncology Assoc
    • Summit, New Jersey, United States, 07901
      • Overlook Oncology Center; Summit Medical Group
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • New Mexico Oncology Hematology Consultants
  • New York
    • New York, New York, United States, 10011
      • St. Vincent'S Hospital; Comprehensive Care Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28233-3549
      • Presbyterian Healthcare; Cancer Research Dept
    • Greensboro, North Carolina, United States, 27403
      • Moses Cone Reg Cancer Ctr
    • Hickory, North Carolina, United States, 28602
      • Carolina Oncology Specialists, PA - Hickory
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • Oncology-Hematology of Lehigh Valley, Pc
    • Kingston, Pennsylvania, United States, 18704
      • Medical Oncology Associates
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase-Temple Cancer Center
    • Philadelphia, Pennsylvania, United States, 19104-4283
      • Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology
    • Pittsburgh, Pennsylvania, United States, 15232
      • Uni of Pittsburgh Cancer Inst. ; Oncology
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • West Clinic
  • Texas
    • The Woodlands, Texas, United States, 77380
      • US Oncology
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Intermountain Hematology & Oncology
  • Washington
    • Yakima, Washington, United States, 98902
      • Internal Medicine Associates of Yakima Inc.
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • UNI OF WISCONSIN SCHOOL OF MEDICINE; GI Oncology Research Group, Paul P Carbone Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically confirmed colon carcinoma, AJCC/UICC Stage III (Dukes stage C)
• Complete tumor resection; Patients operated with curative intent and with no macroscopic or microscopic evidence for remaining tumor who can be randomized to either treatment arm within 8 weeks after surgery. As this is an adjuvant trial patients should never have had any evidence of metastatic disease (including presence of tumor cells in the ascites).
• Have a life expectancy of at least 5 years

Exclusion Criteria:

• Pregnant or lactating women
• Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study
• Previous cytotoxic chemotherapy, radiotherapy or immunotherapy, for the currently treated colon cancer
• Patients who have not completely recovered from surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 5-Fluorouracil/Leucovorin (5-FU/LV); Participants were given one of two regimens (each participating center prespecified which regimen they would use for all patients at that center): i) Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or; ii) Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks).	Drug: Leucovorin (LV); Administered by one of two regimens, as specified in the arm description.; Drug: 5-Fluorouracil (5-FU); Administered by one of two regimens, as specified in the arm description.
Experimental: Capecitabine in Combination with Oxaliplatin (XELOX); Capecitabine was administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks).	Drug: Capecitabine; 1000 milligrams per square metre of body surface area (mg/m^2) orally twice daily on days 1-15 of each 3-week cycle.; Other Names: Xeloda; Drug: Oxaliplatin; 130 mg/m^2 intravenous (IV) infusion over two hours on Day 1 of each 3-week cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-Free Survival (DFS) [Number of Events]	Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements.	Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months).
Disease-Free Survival (DFS) [Time to Event]	Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.	Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse-Free Survival (RFS) [Number of Events]	A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment.	Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months).
Relapse-Free Survival (RFS) [Time to Event]	A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.	Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months).
Overall Survival [Number of Events]	Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.	Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
Overall Survival [Time to Event]	Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.	Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
Number of Participants With at Least One Adverse Event by Most Severe Intensity	The intensity of all adverse events (AEs) was categorized according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) (version 3.0) grading system. If an AE had occurred which was not contained in the NCI-CTC, a four-point scale (mild, moderate, severe, life-threatening) was used. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Only the most severe intensity was counted for multiple occurrences of an AE in one individual. See the AEs results table for details.	From time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days).

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28.
• Schmoll HJ, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Hoersch S, Rittweger K, Haller DG. Capecitabine Plus Oxaliplatin Compared With Fluorouracil/Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer: Final Results of the NO16968 Randomized Controlled Phase III Trial. J Clin Oncol. 2015 Nov 10;33(32):3733-40. doi: 10.1200/JCO.2015.60.9107. Epub 2015 Aug 31.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2003
• Primary Completion (Actual): April 21, 2011
• Study Completion (Actual): April 21, 2011

Study Registration Dates

• First Submitted: September 15, 2003
• First Submitted That Met QC Criteria: September 17, 2003
• First Posted (Estimate): September 18, 2003

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: February 14, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Fluorouracil; Capecitabine; Oxaliplatin; Leucovorin
• Other Study ID Numbers: NO16968