AzTrials
AzTrials

Colorectal CancerPhase 3NCT00069121

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

A Phase 3 study testing Capecitabine, Oxaliplatin and Leucovorin (LV) in people with Colorectal Cancer, run by Hoffmann-La Roche at 232 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Capecitabine, Oxaliplatin and Leucovorin (LV)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,886 participants
Where
232 sitesin 29 countries
Study dates
18 Apr 2003to 21 Apr 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

232 sites in 29 countries.

232 sites in 29 countries

United States48 sites

  • New Mexico Oncology Hematology Consultants

    Albuquerque, New Mexico, 87109

  • Central Hematology Oncology Medical Group Inc.

    Alhambra, California, 91801

  • Georgia Cancer Specialists

    Atlanta, Georgia, 30341

  • University of Colorado Health Science Center; Biomedical Research Bldg. Room 511

    Aurora, Colorado, 80045

  • Comprehensive Blood/Cancer Ctr

    Bakersfield, California, 93309

  • Oncology-Hematology of Lehigh Valley, Pc

    Bethlehem, Pennsylvania, 18015

  • Hematology-Oncology Centers of the Northern Rockies

    Billings, Montana, 59101

  • Presbyterian Healthcare; Cancer Research Dept

    Charlotte, North Carolina, 28233-3549

  • Hematology Oncology Associates

    Fort Collins, Colorado, 80528

  • Virginia K. Crossen Cancer Center

    Fullerton, California, 92835

  • West Clinic

    Germantown, Tennessee, 38138

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Moses Cone Reg Cancer Ctr

    Greensboro, North Carolina, 27403

  • Carolina Oncology Specialists, PA - Hickory

    Hickory, North Carolina, 28602

  • Nh Oncology Hematology, Pa

    Hooksett, New Hampshire, 03106

  • Medical Oncology Associates

    Kingston, Pennsylvania, 18704

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33804-1057

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • UNI OF WISCONSIN SCHOOL OF MEDICINE; GI Oncology Research Group, Paul P Carbone Cancer Center

    Madison, Wisconsin, 53792

  • Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • The Cancer Center At Providence Park

    Mobile, Alabama, 36608

  • Morristown Medical Center;Hematology-Oncology Assoc

    Morristown, New Jersey, 07962

  • Ochsner Cancer Inst.

    New Orleans, Louisiana, 70121

  • St. Vincent'S Hospital; Comprehensive Care Center

    New York, New York, 10011

  • West Valley Hematology Oncology The Thomas and Dorothy Leavey Cancer Center

    Northridge, California, 91325

  • Ventura County Hematology-Oncology Specialists

    Oxnard, California, 93030

  • Illinois Cancer Care

    Peoria, Illinois, 61615

  • Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology

    Philadelphia, Pennsylvania, 19104-4283

  • Fox Chase-Temple Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Uni of Pittsburgh Cancer Inst. ; Oncology

    Pittsburgh, Pennsylvania, 15232

  • Wilshire Oncology Medical Group

    Pomona, California, 91767

  • Va Medical Center

    Reno, Nevada, 89502

  • Sutter Cancer Center

    Sacramento, California, 95816

  • St Joseph Oncology

    Saint Joseph, Missouri, 64507

  • Park Nicollet Clinic Cancer Center

    Saint Louis Park, Minnesota, 55416

  • Intermountain Hematology & Oncology

    Salt Lake City, Utah, 84106

  • Scripps Cancer Center

    San Diego, California, 92121

  • Kaiser Permanente San Diego; Hepatology Research

    San Diego, California, 92154

  • Santa Barbara Hematology Oncology Medical Group, Inc.

    Santa Barbara, California, 93105

  • Hematology Oncology Consultants, Inc.

    St Louis, Missouri, 63136

  • Hematology Oncology P.C.

    Stamford, Connecticut, 06902

  • Overlook Oncology Center; Summit Medical Group

    Summit, New Jersey, 07901

  • Hope Center

    Terre Haute, Indiana, 47802

  • US Oncology

    The Woodlands, Texas, 77380

  • San Diego Cancer Center'S Medical Group

    Vista, California, 92083

  • Georgetown Uni Medical Center; Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007

  • Innovative clinical research institute/American institute of research

    Whittier, California, 90603

  • Internal Medicine Associates of Yakima Inc.

    Yakima, Washington, 98902

Other trials in United States

United Kingdom24 sites

  • Aberdeen Royal Infirmary; Medical Oncology Dept

    Aberdeen, AB25 2ZN

  • The Royal Sussex County Hospital; the Sussex Cancer Centre

    Brighton, BN2 5BE

  • West Suffolk Hospital Nhs Trust; Gi Corridor

    Bury St Edmunds, IP33 2QZ

  • Addenbrooke'S Hospital; Univ.Dept.& Mrc Unit of Clin.Oncology & Radiotherapeutics

    Cambridge, CB2 2QH

  • Derbyshire Royal Infirmary; Dept of Oncology

    Derby, DE1 2QY

  • Cruk Clinical Trials Unit; Level 0 Beatson West Of Scotland Cancer Ctr

    Glasgow, G12 0YN

  • Royal Surrey County Hospital; St. Lukes Cancer Centre

    Guildford, GU2 7XX

  • St James Institute of Oncology

    Leeds, LS9 7TF

  • Leicester Royal Infirmary; Dept. of Medical Oncology

    Leicester, LE1 5WW

  • St Thomas Hospital; Oncology Dept

    London, SE1 7EH

  • Royal Marsden Nhs Trust; Consultant Cancer Physician

    London, SW3 6JJ

  • Hammersmith Hospital; Mrc Clinical Science Centre

    London, W12 OHS

  • Charing Cross Hospital; Medical Oncology.

    London, W6 8RF

  • Maidstone Hospital

    Maidstone, ME16 9QQ

  • Christie Hospital; Breast Cancer Research Office

    Manchester, M20 4QL

  • James Cook Uni Hospital

    Middlesbrough, TS4 3BW

  • Northern Centre for Cancer Care;Oncology

    Newcastle upon Tyne, NE7 7DN

  • Mount Vernon Hospital; Centre For Cancer Treatment

    Northwood, HA6 2RN

  • Nottingham City Hospital; Oncology

    Nottingham, NG5 1PB

  • Derriford Hospital; Plymouth Oncology Centre

    Plymouth, PL6 8DH

  • North Wales Cancer Treatment Centre, Glan Clwyd Hospital

    Rhyl, LL18 5UJ

  • Salisbury District General Hospital; Medical Oncology Dept

    Salisbury, SP2 8BJ

  • Southampton General Hospital; Somers Cancer Research Building

    Southampton, SO16 6YD

  • Royal Marsden Hospital; Dept of Medical Oncology

    Sutton, SM2 5PT

Other trials in United Kingdom

Canada23 sites

  • Tom Baker Cancer Centre; Dept of Medicine

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute ; Dept of Medical Oncology

    Edmonton, Alberta, T6G 1Z2

  • Queen Elizabeth II Health Sciences Centre; Oncology

    Halifax, Nova Scotia, B3H 2Y9

  • Hamilton Health Sciences - Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Bcca - Cancer Center Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Cite de La Sante de Laval; Hemato-Oncologie

    Laval, Quebec, H7M 3L9

  • Hotel Dieu de Levis; Oncology

    Lévis, Quebec, G6V 3Z1

  • London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre

    Mississauga, Ontario, L5M 2N1

  • Hopital Maisonneuve- Rosemont; Oncology

    Montreal, Quebec, H1T 2M4

  • Chum Campus Notre Dame

    Montreal, Quebec, H2X 0A9

  • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

    Montreal, Quebec, H3T 1E2

  • Hopital Du Sacre Coeur de Montreal; Pneumologie

    Montreal, Quebec, H4J 1C5

  • Lakeridge Health Oshawa; Oncology

    Oshawa, Ontario, L1G 2B9

  • The Ottawa Hospital Cancer Centre; Oncology

    Ottawa, Ontario, K1H 8L6

  • Chuq - Hopital Hotel Dieu de Quebec; Oncology

    Québec, Quebec, G1R 2J6

  • Dr. H. Bliss Murphy Cancer Centre; Oncology

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Bcca-Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Humber River Hospital

    Toronto, Ontario, M3M 0B2

  • Sunnybrook Health Science Centre

    Toronto, Ontario, M4N 3M5

  • University Health Network; Princess Margaret Hospital; Medical Oncology Dept

    Toronto, Ontario, M5G 2M9

  • Bcca - Vancouver Island Cancer Centre; Oncology

    Victoria, British Columbia, V8R 6V5

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Spain20 sites

  • Hospital Univ Vall d'Hebron; Servicio de Oncologia

    Barcelona, 08035

  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología

    Barcelona, 08036

  • Hospital Duran i Reynals; Oncologia

    Barcelona, 08907

  • Hospital de Cruces; Servicio de Oncologia

    Bilbao, Vizcaya, 48903

  • Hospital Universitario Reina Sofia; Servicio de Oncologia

    Córdoba, Cordoba, 14004

  • Hospital General Universitario de Elche; Servicio de Oncologia

    Elche, Alicante, 03203

  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

    Jaén, 23007

  • Hospital Severo Ochoa; Servicio de Oncologia

    Leganés, Madrid, 28911

  • Hospital Universitario de la Princesa; Servicio de Oncologia

    Madrid, 28006

  • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

    Madrid, 28007

  • Hospital Universitario Clínico San Carlos; Servicio de Oncologia

    Madrid, 28040

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

  • Hospital Universitario La Paz; Servicio de Oncologia

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro; Servicio de Oncologia

    Majadahonda, Madrid, 28222

  • Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

    Málaga, 29010

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07014

  • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

    Santander, Cantabria, 39008

  • Instituto Valenciano Oncologia; Oncologia Medica

    Valencia, 46009

  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

    Valencia, 46010

  • Hospital Universitario la Fe; Servicio de Oncologia

    Valencia, 46026

Other trials in Spain

Israel12 sites

  • Soroka Medical Center; Oncology Dept

    Beersheba, 8410100

  • Rambam Medical Center; Oncology

    Haifa, 3109601

  • Shaare Zedek Medical Center; Oncology Dept

    Jerusalem, 9103102

  • Hadassah Ein Karem Hospital; Oncology Dept

    Jerusalem, 9112000

  • Meir Medical Center; Oncology

    Kfar Saba, 4428164

  • Nahariya Hospital; Oncology

    Nahariya, 22100

  • Rabin Medical Center; Oncology Dept

    Petah Tikva, 4941492

  • Golda Hasharon Medical Center; Oncology

    Petah Tikva

  • Chaim Sheba Medical Center; Oncology Dept

    Ramat Gan, 52620-00

  • Kaplan Medical Center; Oncology Inst.

    Rehovot, 7610001

  • Sourasky / Ichilov Hospital; Oncology Department

    Tel Aviv, 64239-06

  • Assaf Harofeh; Oncology

    Tsrifin, 6093000

Other trials in Israel

China11 sites

  • Cancer Hospital Chinese Academy of Medical Sciences.

    Beijing, 100021

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515

  • The Second Affiliated Hospital of Zhejiang University College

    Hangzhou, 310009

  • The 1st Affiliated Hospital of Nanchang Unversity

    Nanchang, 330006

  • Jiangsu Cancer Hospital

    Nanjing, 210009

  • Shandong Cancer Hospital; Oncology

    Shandong, 250117

  • Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

    Shanghai, 200025

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200092

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

  • Tianjin Cancer Hospital

    Tianjin, 300060

  • Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

    Wuhan, 430030

Other trials in China

Italy11 sites

  • A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica

    Ancona, The Marches, 60121

  • Asst Papa Giovanni XXIII; Oncologia Medica

    Bergamo, Lombardy, 24127

  • Ospedale Cervesi di Cattolica; ONCOLOGIA

    Cattolica, Emilia-Romagna, 47841

  • Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical

    Genoa, Liguria, 16132

  • Ospedale Civile; Unita Operativa Di Oncologia Medica

    Livorno, Tuscany, 57100

  • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

    Milan, Lombardy, 20141

  • Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

    Parma, Emilia-Romagna, 43100

  • Azienda Usl 7; Dept. Oncologico

    Poggibonsi, Tuscany, 53036

  • Ospedale Degli Infermi; Divisione Di Oncologia

    Rimini, Emilia-Romagna, 47900

  • Ospedale Civile; Oncologia Medica

    Sassari, Sardinia, 07100

  • Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Australia7 sites

  • Box Hill Hospital; Oncology

    Box Hill, Victoria, 3128

  • Royal Prince Alfred Hospital; Medical Oncology

    Camperdown, New South Wales, 2050

  • Footscray Hospital

    Footscray, Victoria, 3011

  • St John of God Hospital; Medical Oncology

    Perth, Western Australia, 6008

  • Port Macquarie Base Hospital; Oncology

    Port Macquarie, New South Wales, 2444

  • Southern Medical Day Care; Clinical Trials Unit

    Wollongong, New South Wales, 2500

  • Queen Elizabeth Hospital; Medical Oncology

    Woodville South, South Australia, 5011

Other trials in Australia

Greece6 sites

  • Evangelismos Hospital; Medical Oncology

    Athens, 10676

  • Per. Gen. Hospital Ippokrateion; Oncology Dept.

    Athens, 11527

  • Univ General Hosp Heraklion; Medical Oncology

    Heraklion, 711 10

  • University Hospital of Patras Medical Oncology

    Pátrai, 265 04

  • Theagenio Anticancer Hospital; 3Rd Oncology Clinic

    Thessaloniki, 546 39

  • Theageneio Anticancer Hospital; Gastroenterology

    Thessaloniki, 56439

Other trials in Greece

Poland6 sites

  • Rydygiera Hospital; Chemotherapy

    Krakow, 31-826

  • Wojewodzki Szpital Specjalistyczny Im. M. Kopernika; Oddzial Chorob Rozrostowych

    Lodz, 93-509

  • Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii

    Poznan, 61-866

  • Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

    Szczecin, 71-730

  • Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Klinika Nowotworow Jelita Grubego

    Warsaw, 02-781

  • Lubuski Osrodek Onkologii, Szpital Wojewodzki; Oddzial Onkologii

    Zielona Góra, 65-046

Other trials in Poland

Belgium5 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • GHdC Site Notre Dame

    Charleroi, 6000

  • UZ Gent

    Ghent, 9000

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

New Zealand5 sites

  • Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

    Auckland, 1023

  • Christchurch Hospital; Dept of Oncology

    Christchurch

  • Dunedin Hospital; Oncology - Haematology Clinical Practice Group

    Dunedin, 9016

  • Palmerston North Hospital; Regional Cancer Treatment Service

    Palmerston North, 4442

  • Wellington Hospital; Regional Oncology Unit

    Wellington, 6002

Other trials in New Zealand

South Africa5 sites

  • Panorama Medical Clinic; Oncology Unit

    Cape Town, 7500

  • Hopelands Cancer Centre; Oncology

    Durban, 4001

  • Hopelands Cancer Centre ST. ANNES HOSPITAL; DEPT. OF ONCOLOGY

    Pietermaritzburg, 3201

  • Little Company of Mary Hospital; Mary Potter Oncology Centre

    Pretoria, 0001

  • Sandton Oncology Medical Group

    Sandton, 2196

Other trials in South Africa

South Korea5 sites

  • Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

    Seoul, 03080

  • Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology

    Seoul, 03722

  • Hanyang Uni Hospital; Dept. of Internal Medicine , Section of Hemato-Oncology

    Seoul, 133-792

  • Samsung Medical Centre; Division of Hematology/Oncology

    Seoul, 135-710

  • Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

    Seoul, 138-736

Other trials in South Korea

Thailand5 sites

  • Bumrungrad Hospital Foundation; Horizon Centre

    Bangkok, 10110

  • Pramongkutklao Hospital; Medicine - Medical Oncology Unit

    Bangkok, 10400

  • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

    Bangkok, 10400

  • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

    Bangkok, 10700

  • Srinagarind Hospital; Medical Oncology Unit

    Khon Kaen, 40002

Other trials in Thailand

France4 sites

  • Hopital Louis Pasteur; Medecine B

    Colmar, 68024

  • Hopital Claude Huriez; Medecine Interne Oncologie

    Lille, 59037

  • Institut Paoli Calmettes; Oncologie Medicale

    Marseille, 13273

  • Hopital Civil; Hematologie Oncologie

    Strasbourg, 67091

Other trials in France

Germany4 sites

  • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

    Freiburg im Breisgau, 79110

  • Universitaetsklinikum Halle; Klinik u.Poliklinik fuer Innere Medizin IV

    Halle, 06120

  • Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie

    Magdeburg, 39130

  • Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

    Trier, 54290

Other trials in Germany

Hungary4 sites

  • Ogyi, Orszagos Gyogyszereszeti Intezet

    Budapest, 1051

  • Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X

    Budapest, 1097

  • Orszagos Onkologial Intezet; Onkologiai Osztaly X

    Budapest, 1122

  • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

    Szeged, 6720

Other trials in Hungary

Mexico4 sites

  • Centro Estatal de Cancerología

    Chihuahua City, 31000

  • Hospital Christus Muguerza Del Parque; Centro de Rehabilitacion

    Chihuahua City, 31000

  • Clinica de Especialidades # 30 Dr. Humberto Torres Sangines; Oncology

    Mexicali, 21100

  • Instituto Nacional De Ciencias Medicas Y Nutricion; Nefrology

    Mexico City, 14000

Other trials in Mexico

Russia4 sites

  • N.N.Burdenko Main Military Clinical Hospital; Chemotherapy

    Moscow, 105229

  • Blokhin Cancer Research Center; Combined Treatment

    Moscow, 115478

  • Petrov Research Inst. of Oncology; Dept of Bio-Therapy & Transplantation of Bone Marrow

    Saint Petersburg, 197758

  • St. Petersburg City Clinical Oncological Dispensary; Colorectal (Department 4)

    Saint Petersburg, 198255

Other trials in Russia

Brazil3 sites

  • Hospital de Baleia; Serviço de Oncologia Clínica

    Belo Horizonte, Minas Gerais, 30285-000

  • Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-120

  • Hospital das Clinicas - FMUSP; Gastroenterologia

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Ireland3 sites

  • Mercy Uni Hospital; Deparment of Medical Oncology

    Cork

  • St. James Hospital; Oncology

    Dublin, 8

  • Galway Uni Hospital; Oncology Dept

    Galway

Other trials in Ireland

Portugal3 sites

  • Hospital Jose Joaquim Fernandes; Unidade de Oncologia Medica

    Beja, 7801-849

  • Hospital de Santa Maria; Servico de Oncologia Medica

    Lisbon, 1649-035

  • IPO do Porto; Servico de Oncologia Medica

    Porto, 4200-072

Other trials in Portugal

Taiwan3 sites

  • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

    Taipei, 11259

  • Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery

    Taipei

  • Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery

    Taoyuan, 333

Other trials in Taiwan

Finland2 sites

  • Tampere University Hospital; Dept of Oncology

    Tampere, 33520

  • Turku Uni Central Hospital; Oncology Clinics

    Turku, 20520

Other trials in Finland

Singapore2 sites

  • National University Hospital; National University Cancer Institute, Singapore (NCIS)

    Singapore, 119228

  • National Cancer Centre; Medical Oncology

    Singapore, 169610

Other trials in Singapore

Hong Kong1 site

  • Queen Mary Hospital; Surgery

    Hong Kong, 852

Other trials in Hong Kong

Panama1 site

  • Isthmian Medical Research Center, S.A.; Oncology

    Panama City

Other trials in Panama

Switzerland1 site

  • Universitaetsspital Basel; Onkologie

    Basel, 4031

Other trials in Switzerland

About this study

Official title: 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.

Being tested
Capecitabine, Oxaliplatin, Leucovorin (LV), 5-Fluorouracil (5-FU)
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

    Also called Xeloda

    1000 milligrams per square metre of body surface area (mg/m^2) orally twice daily on days 1-15 of each 3-week cycle.

  • OxaliplatinDrug

    130 mg/m^2 intravenous (IV) infusion over two hours on Day 1 of each 3-week cycle.

  • Leucovorin (LV)Drug

    Administered by one of two regimens, as specified in the arm description.

  • 5-Fluorouracil (5-FU)Drug

    Administered by one of two regimens, as specified in the arm description.

Study groups in NCT00069121
Study groupRoleWhat they receive
5-Fluorouracil/Leucovorin (5-FU/LV)Active comparatorParticipants 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).
Receives: Drug: Leucovorin (LV); Drug: 5-Fluorouracil (5-FU)
Capecitabine in Combination with Oxaliplatin (XELOX)ExperimentalCapecitabine 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).
Receives: Drug: Capecitabine; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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).

  2. 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.

    Measured: 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 outcomes (5)

  1. 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.

    Measured: 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).

  2. 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.

    Measured: 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).

  3. 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.

    Measured: Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).

  4. 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.

    Measured: Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).

  5. 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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2003 (estimated)
  2. Study start18 Apr 2003
  3. Primary completion21 Apr 2011
  4. Study completion21 Apr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,886 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00069121
Sponsor's protocol ID
NO16968
Status last verified
Feb 2020
First submitted
15 Sep 2003
Last updated
6 Mar 2020

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.

    PubMed 36306483

  • 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.

    PubMed 26324362

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Capecitabine, Oxaliplatin and Leucovorin (LV) in people with Colorectal Cancer, run by Hoffmann-La Roche at 232 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 232 sites in United States, United Kingdom, Canada, Spain, Israel and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-Free Survival (DFS) [Number of Events] (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00069121, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.

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