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)
1 other identifier
interventional
1,886
29 countries
232
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 colorectal-cancer
Started Apr 2003
Typical duration for phase_3 colorectal-cancer
232 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 18, 2003
CompletedFirst Submitted
Initial submission to the registry
September 15, 2003
CompletedFirst Posted
Study publicly available on registry
September 18, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2011
CompletedResults Posted
Study results publicly available
July 29, 2011
CompletedMarch 6, 2020
February 1, 2020
8 years
September 15, 2003
March 31, 2011
February 14, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Relapse-Free Survival (RFS) [Number of Events]
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]
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]
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]
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
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).
Study Arms (2)
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).
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).
Interventions
1000 milligrams per square metre of body surface area (mg/m\^2) orally twice daily on days 1-15 of each 3-week cycle.
130 mg/m\^2 intravenous (IV) infusion over two hours on Day 1 of each 3-week cycle.
Administered by one of two regimens, as specified in the arm description.
Administered by one of two regimens, as specified in the arm description.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (232)
The Cancer Center At Providence Park
Mobile, Alabama, 36608, United States
Central Hematology Oncology Medical Group Inc.
Alhambra, California, 91801, United States
Comprehensive Blood/Cancer Ctr
Bakersfield, California, 93309, United States
Virginia K. Crossen Cancer Center
Fullerton, California, 92835, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
West Valley Hematology Oncology The Thomas and Dorothy Leavey Cancer Center
Northridge, California, 91325, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030, United States
Wilshire Oncology Medical Group
Pomona, California, 91767, United States
Sutter Cancer Center
Sacramento, California, 95816, United States
Scripps Cancer Center
San Diego, California, 92121, United States
Kaiser Permanente San Diego; Hepatology Research
San Diego, California, 92154, United States
Santa Barbara Hematology Oncology Medical Group, Inc.
Santa Barbara, California, 93105, United States
San Diego Cancer Center'S Medical Group
Vista, California, 92083, United States
Innovative clinical research institute/American institute of research
Whittier, California, 90603, United States
University of Colorado Health Science Center; Biomedical Research Bldg. Room 511
Aurora, Colorado, 80045, United States
Hematology Oncology Associates
Fort Collins, Colorado, 80528, United States
Hematology Oncology P.C.
Stamford, Connecticut, 06902, United States
Georgetown Uni Medical Center; Lombardi Cancer Center
Washington D.C., District of Columbia, 20007, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33804-1057, United States
Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Georgia Cancer Specialists
Atlanta, Georgia, 30341, United States
Illinois Cancer Care
Peoria, Illinois, 61615, United States
Hope Center
Terre Haute, Indiana, 47802, United States
Ochsner Cancer Inst.
New Orleans, Louisiana, 70121, United States
Park Nicollet Clinic Cancer Center
Saint Louis Park, Minnesota, 55416, United States
St Joseph Oncology
Saint Joseph, Missouri, 64507, United States
Hematology Oncology Consultants, Inc.
St Louis, Missouri, 63136, United States
Hematology-Oncology Centers of the Northern Rockies
Billings, Montana, 59101, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Va Medical Center
Reno, Nevada, 89502, United States
Nh Oncology Hematology, Pa
Hooksett, New Hampshire, 03106, United States
Morristown Medical Center;Hematology-Oncology Assoc
Morristown, New Jersey, 07962, United States
Overlook Oncology Center; Summit Medical Group
Summit, New Jersey, 07901, United States
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109, United States
St. Vincent'S Hospital; Comprehensive Care Center
New York, New York, 10011, United States
Presbyterian Healthcare; Cancer Research Dept
Charlotte, North Carolina, 28233-3549, United States
Moses Cone Reg Cancer Ctr
Greensboro, North Carolina, 27403, United States
Carolina Oncology Specialists, PA - Hickory
Hickory, North Carolina, 28602, United States
Oncology-Hematology of Lehigh Valley, Pc
Bethlehem, Pennsylvania, 18015, United States
Medical Oncology Associates
Kingston, Pennsylvania, 18704, United States
Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology
Philadelphia, Pennsylvania, 19104-4283, United States
Fox Chase-Temple Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Uni of Pittsburgh Cancer Inst. ; Oncology
Pittsburgh, Pennsylvania, 15232, United States
West Clinic
Germantown, Tennessee, 38138, United States
US Oncology
The Woodlands, Texas, 77380, United States
Intermountain Hematology & Oncology
Salt Lake City, Utah, 84106, United States
Internal Medicine Associates of Yakima Inc.
Yakima, Washington, 98902, United States
UNI OF WISCONSIN SCHOOL OF MEDICINE; GI Oncology Research Group, Paul P Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Royal Prince Alfred Hospital; Medical Oncology
Camperdown, New South Wales, 2050, Australia
Port Macquarie Base Hospital; Oncology
Port Macquarie, New South Wales, 2444, Australia
Southern Medical Day Care; Clinical Trials Unit
Wollongong, New South Wales, 2500, Australia
Queen Elizabeth Hospital; Medical Oncology
Woodville South, South Australia, 5011, Australia
Box Hill Hospital; Oncology
Box Hill, Victoria, 3128, Australia
Footscray Hospital
Footscray, Victoria, 3011, Australia
St John of God Hospital; Medical Oncology
Perth, Western Australia, 6008, Australia
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
GHdC Site Notre Dame
Charleroi, 6000, Belgium
UZ Gent
Ghent, 9000, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
Hospital de Baleia; Serviço de Oncologia Clínica
Belo Horizonte, Minas Gerais, 30285-000, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, 17210-120, Brazil
Hospital das Clinicas - FMUSP; Gastroenterologia
São Paulo, São Paulo, 05403-000, Brazil
Tom Baker Cancer Centre; Dept of Medicine
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute ; Dept of Medical Oncology
Edmonton, Alberta, T6G 1Z2, Canada
Bcca - Cancer Center Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
Bcca-Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2, Canada
Bcca - Vancouver Island Cancer Centre; Oncology
Victoria, British Columbia, V8R 6V5, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
Dr. H. Bliss Murphy Cancer Centre; Oncology
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Queen Elizabeth II Health Sciences Centre; Oncology
Halifax, Nova Scotia, B3H 2Y9, Canada
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
Mississauga, Ontario, L5M 2N1, Canada
Lakeridge Health Oshawa; Oncology
Oshawa, Ontario, L1G 2B9, Canada
The Ottawa Hospital Cancer Centre; Oncology
Ottawa, Ontario, K1H 8L6, Canada
Humber River Hospital
Toronto, Ontario, M3M 0B2, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, M5G 2M9, Canada
Cite de La Sante de Laval; Hemato-Oncologie
Laval, Quebec, H7M 3L9, Canada
Hotel Dieu de Levis; Oncology
Lévis, Quebec, G6V 3Z1, Canada
Hopital Maisonneuve- Rosemont; Oncology
Montreal, Quebec, H1T 2M4, Canada
Chum Campus Notre Dame
Montreal, Quebec, H2X 0A9, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, H3T 1E2, Canada
Hopital Du Sacre Coeur de Montreal; Pneumologie
Montreal, Quebec, H4J 1C5, Canada
Chuq - Hopital Hotel Dieu de Quebec; Oncology
Québec, Quebec, G1R 2J6, Canada
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, 100021, China
Nanfang Hospital, Southern Medical University
Guangzhou, 510515, China
The Second Affiliated Hospital of Zhejiang University College
Hangzhou, 310009, China
The 1st Affiliated Hospital of Nanchang Unversity
Nanchang, 330006, China
Jiangsu Cancer Hospital
Nanjing, 210009, China
Shandong Cancer Hospital; Oncology
Shandong, 250117, China
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
Shanghai, 200025, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092, China
Fudan University Shanghai Cancer Center
Shanghai, 200120, China
Tianjin Cancer Hospital
Tianjin, 300060, China
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan, 430030, China
Tampere University Hospital; Dept of Oncology
Tampere, 33520, Finland
Turku Uni Central Hospital; Oncology Clinics
Turku, 20520, Finland
Hopital Louis Pasteur; Medecine B
Colmar, 68024, France
Hopital Claude Huriez; Medecine Interne Oncologie
Lille, 59037, France
Institut Paoli Calmettes; Oncologie Medicale
Marseille, 13273, France
Hopital Civil; Hematologie Oncologie
Strasbourg, 67091, France
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg im Breisgau, 79110, Germany
Universitaetsklinikum Halle; Klinik u.Poliklinik fuer Innere Medizin IV
Halle, 06120, Germany
Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie
Magdeburg, 39130, Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
Trier, 54290, Germany
Evangelismos Hospital; Medical Oncology
Athens, 10676, Greece
Per. Gen. Hospital Ippokrateion; Oncology Dept.
Athens, 11527, Greece
Univ General Hosp Heraklion; Medical Oncology
Heraklion, 711 10, Greece
University Hospital of Patras Medical Oncology
Pátrai, 265 04, Greece
Theagenio Anticancer Hospital; 3Rd Oncology Clinic
Thessaloniki, 546 39, Greece
Theageneio Anticancer Hospital; Gastroenterology
Thessaloniki, 56439, Greece
Queen Mary Hospital; Surgery
Hong Kong, 852, Hong Kong
Ogyi, Orszagos Gyogyszereszeti Intezet
Budapest, 1051, Hungary
Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X
Budapest, 1097, Hungary
Orszagos Onkologial Intezet; Onkologiai Osztaly X
Budapest, 1122, Hungary
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
Szeged, 6720, Hungary
Mercy Uni Hospital; Deparment of Medical Oncology
Cork, Ireland
St. James Hospital; Oncology
Dublin, 8, Ireland
Galway Uni Hospital; Oncology Dept
Galway, Ireland
Soroka Medical Center; Oncology Dept
Beersheba, 8410100, Israel
Rambam Medical Center; Oncology
Haifa, 3109601, Israel
Shaare Zedek Medical Center; Oncology Dept
Jerusalem, 9103102, Israel
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, 9112000, Israel
Meir Medical Center; Oncology
Kfar Saba, 4428164, Israel
Nahariya Hospital; Oncology
Nahariya, 22100, Israel
Rabin Medical Center; Oncology Dept
Petah Tikva, 4941492, Israel
Golda Hasharon Medical Center; Oncology
Petah Tikva, Israel
Chaim Sheba Medical Center; Oncology Dept
Ramat Gan, 52620-00, Israel
Kaplan Medical Center; Oncology Inst.
Rehovot, 7610001, Israel
Sourasky / Ichilov Hospital; Oncology Department
Tel Aviv, 64239-06, Israel
Assaf Harofeh; Oncology
Ẕerifin, 6093000, Israel
Ospedale Cervesi di Cattolica; ONCOLOGIA
Cattolica, Emilia-Romagna, 47841, Italy
Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
Parma, Emilia-Romagna, 43100, Italy
Ospedale Degli Infermi; Divisione Di Oncologia
Rimini, Emilia-Romagna, 47900, Italy
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
Udine, Friuli Venezia Giulia, 33100, Italy
Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical
Genoa, Liguria, 16132, Italy
Asst Papa Giovanni XXIII; Oncologia Medica
Bergamo, Lombardy, 24127, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
Milan, Lombardy, 20141, Italy
Ospedale Civile; Oncologia Medica
Sassari, Sardinia, 07100, Italy
A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica
Ancona, The Marches, 60121, Italy
Ospedale Civile; Unita Operativa Di Oncologia Medica
Livorno, Tuscany, 57100, Italy
Azienda Usl 7; Dept. Oncologico
Poggibonsi, Tuscany, 53036, Italy
Centro Estatal de Cancerología
Chihuahua City, 31000, Mexico
Hospital Christus Muguerza Del Parque; Centro de Rehabilitacion
Chihuahua City, 31000, Mexico
Clinica de Especialidades # 30 Dr. Humberto Torres Sangines; Oncology
Mexicali, 21100, Mexico
Instituto Nacional De Ciencias Medicas Y Nutricion; Nefrology
Mexico City, 14000, Mexico
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
Auckland, 1023, New Zealand
Christchurch Hospital; Dept of Oncology
Christchurch, New Zealand
Dunedin Hospital; Oncology - Haematology Clinical Practice Group
Dunedin, 9016, New Zealand
Palmerston North Hospital; Regional Cancer Treatment Service
Palmerston North, 4442, New Zealand
Wellington Hospital; Regional Oncology Unit
Wellington, 6002, New Zealand
Isthmian Medical Research Center, S.A.; Oncology
Panama City, Panama
Rydygiera Hospital; Chemotherapy
Krakow, 31-826, Poland
Wojewodzki Szpital Specjalistyczny Im. M. Kopernika; Oddzial Chorob Rozrostowych
Lodz, 93-509, Poland
Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii
Poznan, 61-866, Poland
Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
Szczecin, 71-730, Poland
Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Klinika Nowotworow Jelita Grubego
Warsaw, 02-781, Poland
Lubuski Osrodek Onkologii, Szpital Wojewodzki; Oddzial Onkologii
Zielona Góra, 65-046, Poland
Hospital Jose Joaquim Fernandes; Unidade de Oncologia Medica
Beja, 7801-849, Portugal
Hospital de Santa Maria; Servico de Oncologia Medica
Lisbon, 1649-035, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto, 4200-072, Portugal
N.N.Burdenko Main Military Clinical Hospital; Chemotherapy
Moscow, 105229, Russia
Blokhin Cancer Research Center; Combined Treatment
Moscow, 115478, Russia
Petrov Research Inst. of Oncology; Dept of Bio-Therapy & Transplantation of Bone Marrow
Saint Petersburg, 197758, Russia
St. Petersburg City Clinical Oncological Dispensary; Colorectal (Department 4)
Saint Petersburg, 198255, Russia
National University Hospital; National University Cancer Institute, Singapore (NCIS)
Singapore, 119228, Singapore
National Cancer Centre; Medical Oncology
Singapore, 169610, Singapore
Panorama Medical Clinic; Oncology Unit
Cape Town, 7500, South Africa
Hopelands Cancer Centre; Oncology
Durban, 4001, South Africa
Hopelands Cancer Centre ST. ANNES HOSPITAL; DEPT. OF ONCOLOGY
Pietermaritzburg, 3201, South Africa
Little Company of Mary Hospital; Mary Potter Oncology Centre
Pretoria, 0001, South Africa
Sandton Oncology Medical Group
Sandton, 2196, South Africa
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
Seoul, 03080, South Korea
Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology
Seoul, 03722, South Korea
Hanyang Uni Hospital; Dept. of Internal Medicine , Section of Hemato-Oncology
Seoul, 133-792, South Korea
Samsung Medical Centre; Division of Hematology/Oncology
Seoul, 135-710, South Korea
Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
Seoul, 138-736, South Korea
Hospital General Universitario de Elche; Servicio de Oncologia
Elche, Alicante, 03203, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07014, Spain
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Santander, Cantabria, 39008, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba, 14004, Spain
Hospital Severo Ochoa; Servicio de Oncologia
Leganés, Madrid, 28911, Spain
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
Majadahonda, Madrid, 28222, Spain
Hospital de Cruces; Servicio de Oncologia
Bilbao, Vizcaya, 48903, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, 08035, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, 08036, Spain
Hospital Duran i Reynals; Oncologia
Barcelona, 08907, Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaén, 23007, Spain
Hospital Universitario de la Princesa; Servicio de Oncologia
Madrid, 28006, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, 28007, Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 28041, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, 28046, Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Málaga, 29010, Spain
Instituto Valenciano Oncologia; Oncologia Medica
Valencia, 46009, Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010, Spain
Hospital Universitario la Fe; Servicio de Oncologia
Valencia, 46026, Spain
Universitaetsspital Basel; Onkologie
Basel, 4031, Switzerland
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
Taipei, 11259, Taiwan
Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery
Taipei, Taiwan
Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery
Taoyuan District, 333, Taiwan
Bumrungrad Hospital Foundation; Horizon Centre
Bangkok, 10110, Thailand
Pramongkutklao Hospital; Medicine - Medical Oncology Unit
Bangkok, 10400, Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Bangkok, 10400, Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, 10700, Thailand
Srinagarind Hospital; Medical Oncology Unit
Khon Kaen, 40002, Thailand
Aberdeen Royal Infirmary; Medical Oncology Dept
Aberdeen, AB25 2ZN, United Kingdom
The Royal Sussex County Hospital; the Sussex Cancer Centre
Brighton, BN2 5BE, United Kingdom
West Suffolk Hospital Nhs Trust; Gi Corridor
Bury St Edmunds, IP33 2QZ, United Kingdom
Addenbrooke'S Hospital; Univ.Dept.& Mrc Unit of Clin.Oncology & Radiotherapeutics
Cambridge, CB2 2QH, United Kingdom
Derbyshire Royal Infirmary; Dept of Oncology
Derby, DE1 2QY, United Kingdom
Cruk Clinical Trials Unit; Level 0 Beatson West Of Scotland Cancer Ctr
Glasgow, G12 0YN, United Kingdom
Royal Surrey County Hospital; St. Lukes Cancer Centre
Guildford, GU2 7XX, United Kingdom
St James Institute of Oncology
Leeds, LS9 7TF, United Kingdom
Leicester Royal Infirmary; Dept. of Medical Oncology
Leicester, LE1 5WW, United Kingdom
St Thomas Hospital; Oncology Dept
London, SE1 7EH, United Kingdom
Royal Marsden Nhs Trust; Consultant Cancer Physician
London, SW3 6JJ, United Kingdom
Hammersmith Hospital; Mrc Clinical Science Centre
London, W12 OHS, United Kingdom
Charing Cross Hospital; Medical Oncology.
London, W6 8RF, United Kingdom
Maidstone Hospital
Maidstone, ME16 9QQ, United Kingdom
Christie Hospital; Breast Cancer Research Office
Manchester, M20 4QL, United Kingdom
James Cook Uni Hospital
Middlesbrough, TS4 3BW, United Kingdom
Northern Centre for Cancer Care;Oncology
Newcastle upon Tyne, NE7 7DN, United Kingdom
Mount Vernon Hospital; Centre For Cancer Treatment
Northwood, HA6 2RN, United Kingdom
Nottingham City Hospital; Oncology
Nottingham, NG5 1PB, United Kingdom
Derriford Hospital; Plymouth Oncology Centre
Plymouth, PL6 8DH, United Kingdom
North Wales Cancer Treatment Centre, Glan Clwyd Hospital
Rhyl, LL18 5UJ, United Kingdom
Salisbury District General Hospital; Medical Oncology Dept
Salisbury, SP2 8BJ, United Kingdom
Southampton General Hospital; Somers Cancer Research Building
Southampton, SO16 6YD, United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology
Sutton, SM2 5PT, United Kingdom
Related Publications (2)
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.
PMID: 36306483DERIVEDSchmoll 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.
PMID: 26324362DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2003
First Posted
September 18, 2003
Study Start
April 18, 2003
Primary Completion
April 21, 2011
Study Completion
April 21, 2011
Last Updated
March 6, 2020
Results First Posted
July 29, 2011
Record last verified: 2020-02