Clinical trial NCT00069121: A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2003-09-18
Enrollment: 1886
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Disease-Free Survival (DFS) [Number of Events]
timeFrame: 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).
measure: Disease-Free Survival (DFS) [Time to Event]
timeFrame: 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:
measure: Relapse-Free Survival (RFS) [Number of Events]
timeFrame: 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).
measure: Relapse-Free Survival (RFS) [Time to Event]
timeFrame: 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).
measure: Overall Survival [Number of Events]
timeFrame: Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
measure: Overall Survival [Time to Event]
timeFrame: Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
measure: Number of Participants With at Least One Adverse Event by Most Severe Intensity
timeFrame: 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).
Other outcomes:
Locations:
city: Mobile
country: United States
facility: The Cancer Center At Providence Park
state: Alabama
city: Alhambra
country: United States
facility: Central Hematology Oncology Medical Group Inc.
state: California
city: Bakersfield
country: United States
facility: Comprehensive Blood/Cancer Ctr
state: California
city: Fullerton
country: United States
facility: Virginia K. Crossen Cancer Center
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Northridge
country: United States
facility: West Valley Hematology Oncology The Thomas and Dorothy Leavey Cancer Center
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology-Oncology Specialists
state: California
city: Pomona
country: United States
facility: Wilshire Oncology Medical Group
state: California
city: Sacramento
country: United States
facility: Sutter Cancer Center
state: California
city: San Diego
country: United States
facility: Scripps Cancer Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente San Diego; Hepatology Research
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Hematology Oncology Medical Group, Inc.
state: California
city: Vista
country: United States
facility: San Diego Cancer Center'S Medical Group
state: California
city: Whittier
country: United States
facility: Innovative clinical research institute/American institute of research
state: California
city: Aurora
country: United States
facility: University of Colorado Health Science Center; Biomedical Research Bldg. Room 511
state: Colorado
city: Fort Collins
country: United States
facility: Hematology Oncology Associates
state: Colorado
city: Stamford
country: United States
facility: Hematology Oncology P.C.
state: Connecticut
city: Washington
country: United States
facility: Georgetown Uni Medical Center; Lombardi Cancer Center
state: District of Columbia
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Miami
country: United States
facility: Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Terre Haute
country: United States
facility: Hope Center
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Cancer Inst.
state: Louisiana
city: Saint Louis Park
country: United States
facility: Park Nicollet Clinic Cancer Center
state: Minnesota
city: Saint Joseph
country: United States
facility: St Joseph Oncology
state: Missouri
city: Saint Louis
country: United States
facility: Hematology Oncology Consultants, Inc.
state: Missouri
city: Billings
country: United States
facility: Hematology-Oncology Centers of the Northern Rockies
state: Montana
city: Great Falls
country: United States
facility: Great Falls Clinic
state: Montana
city: Reno
country: United States
facility: Va Medical Center
state: Nevada
city: Hooksett
country: United States
facility: Nh Oncology Hematology, Pa
state: New Hampshire
city: Morristown
country: United States
facility: Morristown Medical Center;Hematology-Oncology Assoc
state: New Jersey
city: Summit
country: United States
facility: Overlook Oncology Center; Summit Medical Group
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Oncology Hematology Consultants
state: New Mexico
city: New York
country: United States
facility: St. Vincent'S Hospital; Comprehensive Care Center
state: New York
city: Charlotte
country: United States
facility: Presbyterian Healthcare; Cancer Research Dept
state: North Carolina
city: Greensboro
country: United States
facility: Moses Cone Reg Cancer Ctr
state: North Carolina
city: Hickory
country: United States
facility: Carolina Oncology Specialists, PA - Hickory
state: North Carolina
city: Bethlehem
country: United States
facility: Oncology-Hematology of Lehigh Valley, Pc
state: Pennsylvania
city: Kingston
country: United States
facility: Medical Oncology Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase-Temple Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Uni of Pittsburgh Cancer Inst. ; Oncology
state: Pennsylvania
city: Germantown
country: United States
facility: West Clinic
state: Tennessee
city: The Woodlands
country: United States
facility: US Oncology
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain Hematology & Oncology
state: Utah
city: Yakima
country: United States
facility: Internal Medicine Associates of Yakima Inc.
state: Washington
city: Madison
country: United States
facility: UNI OF WISCONSIN SCHOOL OF MEDICINE; GI Oncology Research Group, Paul P Carbone Cancer Center
state: Wisconsin
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital; Medical Oncology
state: New South Wales
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital; Oncology
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care; Clinical Trials Unit
state: New South Wales
city: Woodville South
country: Australia
facility: Queen Elizabeth Hospital; Medical Oncology
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital; Oncology
state: Victoria
city: Footscray
country: Australia
facility: Footscray Hospital
state: Victoria
city: Perth
country: Australia
facility: St John of God Hospital; Medical Oncology
state: Western Australia
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Charleroi
country: Belgium
facility: GHdC Site Notre Dame
city: Gent
country: Belgium
facility: UZ Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Belo Horizonte
country: Brazil
facility: Hospital de Baleia; Serviço de Oncologia Clínica
state: MG
city: Jau
country: Brazil
facility: Hospital Amaral Carvalho
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - FMUSP; Gastroenterologia
state: SP
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre; Dept of Medicine
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute ; Dept of Medical Oncology
state: Alberta
city: Kelowna
country: Canada
facility: Bcca - Cancer Center Southern Interior
state: British Columbia
city: Surrey
country: Canada
facility: Bcca-Fraser Valley Cancer Centre
state: British Columbia
city: Victoria
country: Canada
facility: Bcca - Vancouver Island Cancer Centre; Oncology
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: St. John's
country: Canada
facility: Dr. H. Bliss Murphy Cancer Centre; Oncology
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre; Oncology
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Oshawa; Oncology
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre; Oncology
state: Ontario
city: Toronto
country: Canada
facility: Humber River Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Science Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept
state: Ontario
city: Laval
country: Canada
facility: Cite de La Sante de Laval; Hemato-Oncologie
state: Quebec
city: Levis
country: Canada
facility: Hotel Dieu de Levis; Oncology
state: Quebec
city: Montreal
country: Canada
facility: Hopital Maisonneuve- Rosemont; Oncology
state: Quebec
city: Montreal
country: Canada
facility: Chum Campus Notre Dame
state: Quebec
city: Montreal
country: Canada
facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
state: Quebec
city: Montreal
country: Canada
facility: Hopital Du Sacre Coeur de Montreal; Pneumologie
state: Quebec
city: Quebec City
country: Canada
facility: Chuq - Hopital Hotel Dieu de Quebec; Oncology
state: Quebec
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences.
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University College
city: Nanchang
country: China
facility: The 1st Affiliated Hospital of Nanchang Unversity
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Shandong
country: China
facility: Shandong Cancer Hospital; Oncology
city: Shanghai City
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Wuhan
country: China
facility: Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
city: Tampere
country: Finland
facility: Tampere University Hospital; Dept of Oncology
city: Turku
country: Finland
facility: Turku Uni Central Hospital; Oncology Clinics
city: Colmar
country: France
facility: Hopital Louis Pasteur; Medecine B
city: Lille
country: France
facility: Hopital Claude Huriez; Medecine Interne Oncologie
city: Marseille
country: France
facility: Institut Paoli Calmettes; Oncologie Medicale
city: Strasbourg
country: France
facility: Hopital Civil; Hematologie Oncologie
city: Freiburg
country: Germany
facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
city: Halle
country: Germany
facility: Universitaetsklinikum Halle; Klinik u.Poliklinik fuer Innere Medizin IV
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie
city: Trier
country: Germany
facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
city: Athens
country: Greece
facility: Evangelismos Hospital; Medical Oncology
city: Athens
country: Greece
facility: Per. Gen. Hospital Ippokrateion; Oncology Dept.
city: Heraklion
country: Greece
facility: Univ General Hosp Heraklion; Medical Oncology
city: Patras
country: Greece
facility: University Hospital of Patras Medical Oncology
city: Thessaloniki
country: Greece
facility: Theagenio Anticancer Hospital; 3Rd Oncology Clinic
city: Thessaloniki
country: Greece
facility: Theageneio Anticancer Hospital; Gastroenterology
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital; Surgery
city: Budapest
country: Hungary
facility: Ogyi, Orszagos Gyogyszereszeti Intezet
city: Budapest
country: Hungary
facility: Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X
city: Budapest
country: Hungary
facility: Orszagos Onkologial Intezet; Onkologiai Osztaly X
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
city: Cork
country: Ireland
facility: Mercy Uni Hospital; Deparment of Medical Oncology
city: Dublin
country: Ireland
facility: St. James Hospital; Oncology
city: Galway
country: Ireland
facility: Galway Uni Hospital; Oncology Dept
city: Beer Sheva
country: Israel
facility: Soroka Medical Center; Oncology Dept
city: Haifa
country: Israel
facility: Rambam Medical Center; Oncology
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center; Oncology Dept
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem Hospital; Oncology Dept
city: Kfar-Saba
country: Israel
facility: Meir Medical Center; Oncology
city: Nahariya
country: Israel
facility: Nahariya Hospital; Oncology
city: Petach Tikva
country: Israel
facility: Rabin Medical Center; Oncology Dept
city: Petach Tikva
country: Israel
facility: Golda Hasharon Medical Center; Oncology
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center; Oncology Dept
city: Rehovot
country: Israel
facility: Kaplan Medical Center; Oncology Inst.
city: Tel Aviv
country: Israel
facility: Sourasky / Ichilov Hospital; Oncology Department
city: Zerifin
country: Israel
facility: Assaf Harofeh; Oncology
city: Cattolica
country: Italy
facility: Ospedale Cervesi di Cattolica; ONCOLOGIA
state: Emilia-Romagna
city: Parma
country: Italy
facility: Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
state: Emilia-Romagna
city: Rimini
country: Italy
facility: Ospedale Degli Infermi; Divisione Di Oncologia
state: Emilia-Romagna
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
state: Friuli-Venezia Giulia
city: Genova
country: Italy
facility: Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical
state: Liguria
city: Bergamo
country: Italy
facility: Asst Papa Giovanni XXIII; Oncologia Medica
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
state: Lombardia
city: Ancona
country: Italy
facility: A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica
state: Marche
city: Sassari
country: Italy
facility: Ospedale Civile; Oncologia Medica
state: Sardegna
city: Livorno
country: Italy
facility: Ospedale Civile; Unita Operativa Di Oncologia Medica
state: Toscana
city: Poggibonsi
country: Italy
facility: Azienda Usl 7; Dept. Oncologico
state: Toscana
city: Seoul
country: Korea, Republic of
facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
city: Seoul
country: Korea, Republic of
facility: Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology
city: Seoul
country: Korea, Republic of
facility: Hanyang Uni Hospital; Dept. of Internal Medicine , Section of Hemato-Oncology
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Centre; Division of Hematology/Oncology
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
city: Chihuahua
country: Mexico
facility: Centro Estatal de Cancerología
city: Chihuahua
country: Mexico
facility: Hospital Christus Muguerza Del Parque; Centro de Rehabilitacion
city: Mexicali
country: Mexico
facility: Clinica de Especialidades # 30 Dr. Humberto Torres Sangines; Oncology
city: Mexico City
country: Mexico
facility: Instituto Nacional De Ciencias Medicas Y Nutricion; Nefrology
city: Auckland
country: New Zealand
facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
city: Christchurch
country: New Zealand
facility: Christchurch Hospital; Dept of Oncology
city: Dunedin
country: New Zealand
facility: Dunedin Hospital; Oncology - Haematology Clinical Practice Group
city: Palmerston North
country: New Zealand
facility: Palmerston North Hospital; Regional Cancer Treatment Service
city: Wellington
country: New Zealand
facility: Wellington Hospital; Regional Oncology Unit
city: Panama City
country: Panama
facility: Isthmian Medical Research Center, S.A.; Oncology
city: Krakow
country: Poland
facility: Rydygiera Hospital; Chemotherapy
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny Im. M. Kopernika; Oddzial Chorob Rozrostowych
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii
city: Szczecin
country: Poland
facility: Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
city: Warszawa
country: Poland
facility: Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Klinika Nowotworow Jelita Grubego
city: Zielona Gora
country: Poland
facility: Lubuski Osrodek Onkologii, Szpital Wojewodzki; Oddzial Onkologii
city: Beja
country: Portugal
facility: Hospital Jose Joaquim Fernandes; Unidade de Oncologia Medica
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria; Servico de Oncologia Medica
city: Porto
country: Portugal
facility: IPO do Porto; Servico de Oncologia Medica
city: Moscow
country: Russian Federation
facility: N.N.Burdenko Main Military Clinical Hospital; Chemotherapy
city: Moscow
country: Russian Federation
facility: Blokhin Cancer Research Center; Combined Treatment
city: St Petersburg
country: Russian Federation
facility: Petrov Research Inst. of Oncology; Dept of Bio-Therapy & Transplantation of Bone Marrow
city: St Petersburg
country: Russian Federation
facility: St. Petersburg City Clinical Oncological Dispensary; Colorectal (Department 4)
city: Singapore
country: Singapore
facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)
city: Singapore
country: Singapore
facility: National Cancer Centre; Medical Oncology
city: Cape Town
country: South Africa
facility: Panorama Medical Clinic; Oncology Unit
city: Durban
country: South Africa
facility: Hopelands Cancer Centre; Oncology
city: Pietermaritzburg
country: South Africa
facility: Hopelands Cancer Centre ST. ANNES HOSPITAL; DEPT. OF ONCOLOGY
city: Pretoria
country: South Africa
facility: Little Company of Mary Hospital; Mary Potter Oncology Centre
city: Sandton
country: South Africa
facility: Sandton Oncology Medical Group
city: Elche
country: Spain
facility: Hospital General Universitario de Elche; Servicio de Oncologia
state: Alicante
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
state: Cantabria
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Oncologia
state: Cordoba
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Leganes
country: Spain
facility: Hospital Severo Ochoa; Servicio de Oncologia
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia
state: Madrid
city: Bilbao
country: Spain
facility: Hospital de Cruces; Servicio de Oncologia
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología
city: Barcelona
country: Spain
facility: Hospital Duran i Reynals; Oncologia
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz; Servicio de Oncologia
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
city: Valencia
country: Spain
facility: Instituto Valenciano Oncologia; Oncologia Medica
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
city: Valencia
country: Spain
facility: Hospital Universitario la Fe; Servicio de Oncologia
city: Basel
country: Switzerland
facility: Universitaetsspital Basel; Onkologie
city: Taipei City
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery
city: Bangkok
country: Thailand
facility: Bumrungrad Hospital Foundation; Horizon Centre
city: Bangkok
country: Thailand
facility: Pramongkutklao Hospital; Medicine - Medical Oncology Unit
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
city: Bangkok
country: Thailand
facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital; Medical Oncology Unit
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary; Medical Oncology Dept
city: Brighton
country: United Kingdom
facility: The Royal Sussex County Hospital; the Sussex Cancer Centre
city: Bury St Edmunds
country: United Kingdom
facility: West Suffolk Hospital Nhs Trust; Gi Corridor
city: Cambridge
country: United Kingdom
facility: Addenbrooke'S Hospital; Univ.Dept.& Mrc Unit of Clin.Oncology & Radiotherapeutics
city: Derby
country: United Kingdom
facility: Derbyshire Royal Infirmary; Dept of Oncology
city: Glasgow
country: United Kingdom
facility: Cruk Clinical Trials Unit; Level 0 Beatson West Of Scotland Cancer Ctr
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital; St. Lukes Cancer Centre
city: Leeds
country: United Kingdom
facility: St James Institute of Oncology
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary; Dept. of Medical Oncology
city: London
country: United Kingdom
facility: St Thomas Hospital; Oncology Dept
city: London
country: United Kingdom
facility: Royal Marsden Nhs Trust; Consultant Cancer Physician
city: London
country: United Kingdom
facility: Hammersmith Hospital; Mrc Clinical Science Centre
city: London
country: United Kingdom
facility: Charing Cross Hospital; Medical Oncology.
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital; Breast Cancer Research Office
city: Middlesborough
country: United Kingdom
facility: James Cook Uni Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northern Centre for Cancer Care;Oncology
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital; Centre For Cancer Treatment
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital; Oncology
city: Plymouth
country: United Kingdom
facility: Derriford Hospital; Plymouth Oncology Centre
city: Rhyl
country: United Kingdom
facility: North Wales Cancer Treatment Centre, Glan Clwyd Hospital
city: Salisbury
country: United Kingdom
facility: Salisbury District General Hospital; Medical Oncology Dept
city: Southampton
country: United Kingdom
facility: Southampton General Hospital; Somers Cancer Research Building
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital; Dept of Medical Oncology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.