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

Colorectal Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00069121
• Other study ID #: NO16968
• Status: Completed
• Phase: Phase 3
• Start date: April 18, 2003
• Est. completion date: April 21, 2011

Study information

• Verified date: February 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Other known NCT identifiers

• NCT00080691

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1886
• Est. completion date: April 21, 2011
• Est. primary completion date: April 21, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.
• Oxaliplatin
130 mg/m^2 intravenous (IV) infusion over two hours on Day 1 of each 3-week cycle.
• Leucovorin (LV)
Administered by one of two regimens, as specified in the arm description.
• 5-Fluorouracil (5-FU)
Administered by one of two regimens, as specified in the arm description.

Locations

Country	Name	City	State
Australia	Box Hill Hospital; Oncology	Box Hill	Victoria
Australia	Royal Prince Alfred Hospital; Medical Oncology	Camperdown	New South Wales
Australia	Footscray Hospital	Footscray	Victoria
Australia	St John of God Hospital; Medical Oncology	Perth	Western Australia
Australia	Port Macquarie Base Hospital; Oncology	Port Macquarie	New South Wales
Australia	Southern Medical Day Care; Clinical Trials Unit	Wollongong	New South Wales
Australia	Queen Elizabeth Hospital; Medical Oncology	Woodville South	South Australia
Belgium	Cliniques Universitaires St-Luc	Bruxelles
Belgium	GHdC Site Notre Dame	Charleroi
Belgium	UZ Gent	Gent
Belgium	AZ Groeninge	Kortrijk
Belgium	UZ Leuven Gasthuisberg	Leuven
Brazil	Hospital de Baleia; Serviço de Oncologia Clínica	Belo Horizonte	MG
Brazil	Hospital Amaral Carvalho	Jau	SP
Brazil	Hospital das Clinicas - FMUSP; Gastroenterologia	Sao Paulo	SP
Canada	Tom Baker Cancer Centre; Dept of Medicine	Calgary	Alberta
Canada	Cross Cancer Institute ; Dept of Medical Oncology	Edmonton	Alberta
Canada	Queen Elizabeth II Health Sciences Centre; Oncology	Halifax	Nova Scotia
Canada	Hamilton Health Sciences - Juravinski Cancer Centre	Hamilton	Ontario
Canada	Bcca - Cancer Center Southern Interior	Kelowna	British Columbia
Canada	Cite de La Sante de Laval; Hemato-Oncologie	Laval	Quebec
Canada	Hotel Dieu de Levis; Oncology	Levis	Quebec
Canada	London Regional Cancer Centre	London	Ontario
Canada	Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre	Mississauga	Ontario
Canada	Chum Campus Notre Dame	Montreal	Quebec
Canada	Hopital Du Sacre Coeur de Montreal; Pneumologie	Montreal	Quebec
Canada	Hopital Maisonneuve- Rosemont; Oncology	Montreal	Quebec
Canada	McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology	Montreal	Quebec
Canada	Lakeridge Health Oshawa; Oncology	Oshawa	Ontario
Canada	The Ottawa Hospital Cancer Centre; Oncology	Ottawa	Ontario
Canada	Chuq - Hopital Hotel Dieu de Quebec; Oncology	Quebec City	Quebec
Canada	Dr. H. Bliss Murphy Cancer Centre; Oncology	St. John's	Newfoundland and Labrador
Canada	Bcca-Fraser Valley Cancer Centre	Surrey	British Columbia
Canada	Humber River Hospital	Toronto	Ontario
Canada	Sunnybrook Health Science Centre	Toronto	Ontario
Canada	University Health Network; Princess Margaret Hospital; Medical Oncology Dept	Toronto	Ontario
Canada	Bcca - Vancouver Island Cancer Centre; Oncology	Victoria	British Columbia
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
China	Cancer Hospital Chinese Academy of Medical Sciences.	Beijing
China	Nanfang Hospital, Southern Medical University	Guangzhou
China	The Second Affiliated Hospital of Zhejiang University College	Hangzhou
China	The 1st Affiliated Hospital of Nanchang Unversity	Nanchang
China	Jiangsu Cancer Hospital	Nanjing
China	Shandong Cancer Hospital; Oncology	Shandong
China	Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)	Shanghai
China	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai City
China	Tianjin Cancer Hospital	Tianjin
China	Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech	Wuhan
Finland	Tampere University Hospital; Dept of Oncology	Tampere
Finland	Turku Uni Central Hospital; Oncology Clinics	Turku
France	Hopital Louis Pasteur; Medecine B	Colmar
France	Hopital Claude Huriez; Medecine Interne Oncologie	Lille
France	Institut Paoli Calmettes; Oncologie Medicale	Marseille
France	Hopital Civil; Hematologie Oncologie	Strasbourg
Germany	Praxis für Interdisziplinäre Onkologie und Hämatologie GbR	Freiburg
Germany	Universitaetsklinikum Halle; Klinik u.Poliklinik fuer Innere Medizin IV	Halle
Germany	Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie	Magdeburg
Germany	Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie	Trier
Greece	Evangelismos Hospital; Medical Oncology	Athens
Greece	Per. Gen. Hospital Ippokrateion; Oncology Dept.	Athens
Greece	Univ General Hosp Heraklion; Medical Oncology	Heraklion
Greece	University Hospital of Patras Medical Oncology	Patras
Greece	Theageneio Anticancer Hospital; Gastroenterology	Thessaloniki
Greece	Theagenio Anticancer Hospital; 3Rd Oncology Clinic	Thessaloniki
Hong Kong	Queen Mary Hospital; Surgery	Hong Kong
Hungary	Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X	Budapest
Hungary	Ogyi, Orszagos Gyogyszereszeti Intezet	Budapest
Hungary	Orszagos Onkologial Intezet; Onkologiai Osztaly X	Budapest
Hungary	Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika	Szeged
Ireland	Mercy Uni Hospital; Deparment of Medical Oncology	Cork
Ireland	St. James Hospital; Oncology	Dublin
Ireland	Galway Uni Hospital; Oncology Dept	Galway
Israel	Soroka Medical Center; Oncology Dept	Beer Sheva
Israel	Rambam Medical Center; Oncology	Haifa
Israel	Hadassah Ein Karem Hospital; Oncology Dept	Jerusalem
Israel	Shaare Zedek Medical Center; Oncology Dept	Jerusalem
Israel	Meir Medical Center; Oncology	Kfar-Saba
Israel	Nahariya Hospital; Oncology	Nahariya
Israel	Golda Hasharon Medical Center; Oncology	Petach Tikva
Israel	Rabin Medical Center; Oncology Dept	Petach Tikva
Israel	Chaim Sheba Medical Center; Oncology Dept	Ramat Gan
Israel	Kaplan Medical Center; Oncology Inst.	Rehovot
Israel	Sourasky / Ichilov Hospital; Oncology Department	Tel Aviv
Israel	Assaf Harofeh; Oncology	Zerifin
Italy	A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica	Ancona	Marche
Italy	Asst Papa Giovanni XXIII; Oncologia Medica	Bergamo	Lombardia
Italy	Ospedale Cervesi di Cattolica; ONCOLOGIA	Cattolica	Emilia-Romagna
Italy	Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical	Genova	Liguria
Italy	Ospedale Civile; Unita Operativa Di Oncologia Medica	Livorno	Toscana
Italy	Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica	Milano	Lombardia
Italy	Ospedale Regionale Di Parma; Divisione Di Oncologia Medica	Parma	Emilia-Romagna
Italy	Azienda Usl 7; Dept. Oncologico	Poggibonsi	Toscana
Italy	Ospedale Degli Infermi; Divisione Di Oncologia	Rimini	Emilia-Romagna
Italy	Ospedale Civile; Oncologia Medica	Sassari	Sardegna
Italy	Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia	Udine	Friuli-Venezia Giulia
Korea, Republic of	Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology	Seoul
Korea, Republic of	Hanyang Uni Hospital; Dept. of Internal Medicine , Section of Hemato-Oncology	Seoul
Korea, Republic of	Samsung Medical Centre; Division of Hematology/Oncology	Seoul
Korea, Republic of	Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology	Seoul
Korea, Republic of	Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology	Seoul
Mexico	Centro Estatal de Cancerología	Chihuahua
Mexico	Hospital Christus Muguerza Del Parque; Centro de Rehabilitacion	Chihuahua
Mexico	Clinica de Especialidades # 30 Dr. Humberto Torres Sangines; Oncology	Mexicali
Mexico	Instituto Nacional De Ciencias Medicas Y Nutricion; Nefrology	Mexico City
New Zealand	Auckland city hospital; Auckland Regional Cancer Centre and Blood Service	Auckland
New Zealand	Christchurch Hospital; Dept of Oncology	Christchurch
New Zealand	Dunedin Hospital; Oncology - Haematology Clinical Practice Group	Dunedin
New Zealand	Palmerston North Hospital; Regional Cancer Treatment Service	Palmerston North
New Zealand	Wellington Hospital; Regional Oncology Unit	Wellington
Panama	Isthmian Medical Research Center, S.A.; Oncology	Panama City
Poland	Rydygiera Hospital; Chemotherapy	Krakow
Poland	Wojewodzki Szpital Specjalistyczny Im. M. Kopernika; Oddzial Chorob Rozrostowych	Lodz
Poland	Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii	Poznan
Poland	Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych	Szczecin
Poland	Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Klinika Nowotworow Jelita Grubego	Warszawa
Poland	Lubuski Osrodek Onkologii, Szpital Wojewodzki; Oddzial Onkologii	Zielona Gora
Portugal	Hospital Jose Joaquim Fernandes; Unidade de Oncologia Medica	Beja
Portugal	Hospital de Santa Maria; Servico de Oncologia Medica	Lisboa
Portugal	IPO do Porto; Servico de Oncologia Medica	Porto
Russian Federation	Blokhin Cancer Research Center; Combined Treatment	Moscow
Russian Federation	N.N.Burdenko Main Military Clinical Hospital; Chemotherapy	Moscow
Russian Federation	Petrov Research Inst. of Oncology; Dept of Bio-Therapy & Transplantation of Bone Marrow	St Petersburg
Russian Federation	St. Petersburg City Clinical Oncological Dispensary; Colorectal (Department 4)	St Petersburg
Singapore	National Cancer Centre; Medical Oncology	Singapore
Singapore	National University Hospital; National University Cancer Institute, Singapore (NCIS)	Singapore
South Africa	Panorama Medical Clinic; Oncology Unit	Cape Town
South Africa	Hopelands Cancer Centre; Oncology	Durban
South Africa	Hopelands Cancer Centre ST. ANNES HOSPITAL; DEPT. OF ONCOLOGY	Pietermaritzburg
South Africa	Little Company of Mary Hospital; Mary Potter Oncology Centre	Pretoria
South Africa	Sandton Oncology Medical Group	Sandton
Spain	Hospital Clínic i Provincial; Servicio de Hematología y Oncología	Barcelona
Spain	Hospital Duran i Reynals; Oncologia	Barcelona
Spain	Hospital Univ Vall d'Hebron; Servicio de Oncologia	Barcelona
Spain	Hospital de Cruces; Servicio de Oncologia	Bilbao	Vizcaya
Spain	Hospital Universitario Reina Sofia; Servicio de Oncologia	Córdoba	Cordoba
Spain	Hospital General Universitario de Elche; Servicio de Oncologia	Elche	Alicante
Spain	Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia	Jaen
Spain	Hospital Severo Ochoa; Servicio de Oncologia	Leganes	Madrid
Spain	Hospital General Universitario Gregorio Marañon; Servicio de Oncologia	Madrid
Spain	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid
Spain	Hospital Universitario Clínico San Carlos; Servicio de Oncologia	Madrid
Spain	Hospital Universitario de la Princesa; Servicio de Oncologia	Madrid
Spain	Hospital Universitario La Paz; Servicio de Oncologia	Madrid
Spain	Hospital Universitario Puerta de Hierro; Servicio de Oncologia	Majadahonda	Madrid
Spain	Hospital Regional Universitario Carlos Haya; Servicio de Oncologia	Malaga
Spain	Hospital Universitario Son Espases	Palma De Mallorca	Islas Baleares
Spain	Hospital Universitario Marques de Valdecilla; Servicio de Oncologia	Santander	Cantabria
Spain	Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia	Valencia
Spain	Hospital Universitario la Fe; Servicio de Oncologia	Valencia
Spain	Instituto Valenciano Oncologia; Oncologia Medica	Valencia
Switzerland	Universitaetsspital Basel; Onkologie	Basel
Taiwan	Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery	Taipei
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology	Taipei City
Taiwan	Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery	Taoyuan
Thailand	Bumrungrad Hospital Foundation; Horizon Centre	Bangkok
Thailand	Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology	Bangkok
Thailand	Pramongkutklao Hospital; Medicine - Medical Oncology Unit	Bangkok
Thailand	Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc	Bangkok
Thailand	Srinagarind Hospital; Medical Oncology Unit	Khon Kaen
United Kingdom	Aberdeen Royal Infirmary; Medical Oncology Dept	Aberdeen
United Kingdom	The Royal Sussex County Hospital; the Sussex Cancer Centre	Brighton
United Kingdom	West Suffolk Hospital Nhs Trust; Gi Corridor	Bury St Edmunds
United Kingdom	Addenbrooke'S Hospital; Univ.Dept.& Mrc Unit of Clin.Oncology & Radiotherapeutics	Cambridge
United Kingdom	Derbyshire Royal Infirmary; Dept of Oncology	Derby
United Kingdom	Cruk Clinical Trials Unit; Level 0 Beatson West Of Scotland Cancer Ctr	Glasgow
United Kingdom	Royal Surrey County Hospital; St. Lukes Cancer Centre	Guildford
United Kingdom	St James Institute of Oncology	Leeds
United Kingdom	Leicester Royal Infirmary; Dept. of Medical Oncology	Leicester
United Kingdom	Charing Cross Hospital; Medical Oncology.	London
United Kingdom	Hammersmith Hospital; Mrc Clinical Science Centre	London
United Kingdom	Royal Marsden Nhs Trust; Consultant Cancer Physician	London
United Kingdom	St Thomas Hospital; Oncology Dept	London
United Kingdom	Maidstone Hospital	Maidstone
United Kingdom	Christie Hospital; Breast Cancer Research Office	Manchester
United Kingdom	James Cook Uni Hospital	Middlesborough
United Kingdom	Northern Centre for Cancer Care;Oncology	Newcastle Upon Tyne
United Kingdom	Mount Vernon Hospital; Centre For Cancer Treatment	Northwood
United Kingdom	Nottingham City Hospital; Oncology	Nottingham
United Kingdom	Derriford Hospital; Plymouth Oncology Centre	Plymouth
United Kingdom	North Wales Cancer Treatment Centre, Glan Clwyd Hospital	Rhyl
United Kingdom	Salisbury District General Hospital; Medical Oncology Dept	Salisbury
United Kingdom	Southampton General Hospital; Somers Cancer Research Building	Southampton
United Kingdom	Royal Marsden Hospital; Dept of Medical Oncology	Sutton
United States	New Mexico Oncology Hematology Consultants	Albuquerque	New Mexico
United States	Central Hematology Oncology Medical Group Inc.	Alhambra	California
United States	Georgia Cancer Specialists	Atlanta	Georgia
United States	University of Colorado Health Science Center; Biomedical Research Bldg. Room 511	Aurora	Colorado
United States	Comprehensive Blood/Cancer Ctr	Bakersfield	California
United States	Oncology-Hematology of Lehigh Valley, Pc	Bethlehem	Pennsylvania
United States	Hematology-Oncology Centers of the Northern Rockies	Billings	Montana
United States	Presbyterian Healthcare; Cancer Research Dept	Charlotte	North Carolina
United States	Hematology Oncology Associates	Fort Collins	Colorado
United States	Virginia K. Crossen Cancer Center	Fullerton	California
United States	West Clinic	Germantown	Tennessee
United States	Great Falls Clinic	Great Falls	Montana
United States	Moses Cone Reg Cancer Ctr	Greensboro	North Carolina
United States	Carolina Oncology Specialists, PA - Hickory	Hickory	North Carolina
United States	Nh Oncology Hematology, Pa	Hooksett	New Hampshire
United States	Medical Oncology Associates	Kingston	Pennsylvania
United States	Lakeland Regional Cancer Center	Lakeland	Florida
United States	Pacific Shores Medical Group	Long Beach	California
United States	UNI OF WISCONSIN SCHOOL OF MEDICINE; GI Oncology Research Group, Paul P Carbone Cancer Center	Madison	Wisconsin
United States	Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center	Miami	Florida
United States	The Cancer Center At Providence Park	Mobile	Alabama
United States	Morristown Medical Center;Hematology-Oncology Assoc	Morristown	New Jersey
United States	Ochsner Cancer Inst.	New Orleans	Louisiana
United States	St. Vincent'S Hospital; Comprehensive Care Center	New York	New York
United States	West Valley Hematology Oncology The Thomas and Dorothy Leavey Cancer Center	Northridge	California
United States	Ventura County Hematology-Oncology Specialists	Oxnard	California
United States	Illinois Cancer Care	Peoria	Illinois
United States	Fox Chase-Temple Cancer Center	Philadelphia	Pennsylvania
United States	Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology	Philadelphia	Pennsylvania
United States	Uni of Pittsburgh Cancer Inst. ; Oncology	Pittsburgh	Pennsylvania
United States	Wilshire Oncology Medical Group	Pomona	California
United States	Va Medical Center	Reno	Nevada
United States	Sutter Cancer Center	Sacramento	California
United States	St Joseph Oncology	Saint Joseph	Missouri
United States	Hematology Oncology Consultants, Inc.	Saint Louis	Missouri
United States	Park Nicollet Clinic Cancer Center	Saint Louis Park	Minnesota
United States	Intermountain Hematology & Oncology	Salt Lake City	Utah
United States	Kaiser Permanente San Diego; Hepatology Research	San Diego	California
United States	Scripps Cancer Center	San Diego	California
United States	Santa Barbara Hematology Oncology Medical Group, Inc.	Santa Barbara	California
United States	Hematology Oncology P.C.	Stamford	Connecticut
United States	Overlook Oncology Center; Summit Medical Group	Summit	New Jersey
United States	Hope Center	Terre Haute	Indiana
United States	US Oncology	The Woodlands	Texas
United States	San Diego Cancer Center'S Medical Group	Vista	California
United States	Georgetown Uni Medical Center; Lombardi Cancer Center	Washington	District of Columbia
United States	Innovative clinical research institute/American institute of research	Whittier	California
United States	Internal Medicine Associates of Yakima Inc.	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  China,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Ireland,  Israel,  Italy,  Korea, Republic of,  Mexico,  New Zealand,  Panama,  Poland,  Portugal,  Russian Federation,  Singapore,  South Africa,  Spain,  Switzerland,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).