A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer
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
Sites / Locations
- The Cancer Center At Providence Park
- Central Hematology Oncology Medical Group Inc.
- Comprehensive Blood/Cancer Ctr
- Virginia K. Crossen Cancer Center
- Pacific Shores Medical Group
- West Valley Hematology Oncology The Thomas and Dorothy Leavey Cancer Center
- Ventura County Hematology-Oncology Specialists
- Wilshire Oncology Medical Group
- Sutter Cancer Center
- Scripps Cancer Center
- Kaiser Permanente San Diego; Hepatology Research
- Santa Barbara Hematology Oncology Medical Group, Inc.
- San Diego Cancer Center'S Medical Group
- Innovative clinical research institute/American institute of research
- University of Colorado Health Science Center; Biomedical Research Bldg. Room 511
- Hematology Oncology Associates
- Hematology Oncology P.C.
- Georgetown Uni Medical Center; Lombardi Cancer Center
- Lakeland Regional Cancer Center
- Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center
- Georgia Cancer Specialists
- Illinois Cancer Care
- Hope Center
- Ochsner Cancer Inst.
- Park Nicollet Clinic Cancer Center
- St Joseph Oncology
- Hematology Oncology Consultants, Inc.
- Hematology-Oncology Centers of the Northern Rockies
- Great Falls Clinic
- Va Medical Center
- Nh Oncology Hematology, Pa
- Morristown Medical Center;Hematology-Oncology Assoc
- Overlook Oncology Center; Summit Medical Group
- New Mexico Oncology Hematology Consultants
- St. Vincent'S Hospital; Comprehensive Care Center
- Presbyterian Healthcare; Cancer Research Dept
- Moses Cone Reg Cancer Ctr
- Carolina Oncology Specialists, PA - Hickory
- Oncology-Hematology of Lehigh Valley, Pc
- Medical Oncology Associates
- Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology
- Fox Chase-Temple Cancer Center
- Uni of Pittsburgh Cancer Inst. ; Oncology
- West Clinic
- US Oncology
- Intermountain Hematology & Oncology
- Internal Medicine Associates of Yakima Inc.
- UNI OF WISCONSIN SCHOOL OF MEDICINE; GI Oncology Research Group, Paul P Carbone Cancer Center
- Royal Prince Alfred Hospital; Medical Oncology
- Port Macquarie Base Hospital; Oncology
- Southern Medical Day Care; Clinical Trials Unit
- Queen Elizabeth Hospital; Medical Oncology
- Box Hill Hospital; Oncology
- Footscray Hospital
- St John of God Hospital; Medical Oncology
- Cliniques Universitaires St-Luc
- GHdC Site Notre Dame
- UZ Gent
- AZ Groeninge
- UZ Leuven Gasthuisberg
- Hospital de Baleia; Serviço de Oncologia Clínica
- Hospital Amaral Carvalho
- Hospital das Clinicas - FMUSP; Gastroenterologia
- Tom Baker Cancer Centre; Dept of Medicine
- Cross Cancer Institute ; Dept of Medical Oncology
- Bcca - Cancer Center Southern Interior
- Bcca-Fraser Valley Cancer Centre
- Bcca - Vancouver Island Cancer Centre; Oncology
- St. Boniface General Hospital
- Dr. H. Bliss Murphy Cancer Centre; Oncology
- Queen Elizabeth II Health Sciences Centre; Oncology
- Hamilton Health Sciences - Juravinski Cancer Centre
- London Regional Cancer Centre
- Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
- Lakeridge Health Oshawa; Oncology
- The Ottawa Hospital Cancer Centre; Oncology
- Humber River Hospital
- Sunnybrook Health Science Centre
- University Health Network; Princess Margaret Hospital; Medical Oncology Dept
- Cite de La Sante de Laval; Hemato-Oncologie
- Hotel Dieu de Levis; Oncology
- Hopital Maisonneuve- Rosemont; Oncology
- Chum Campus Notre Dame
- McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
- Hopital Du Sacre Coeur de Montreal; Pneumologie
- Chuq - Hopital Hotel Dieu de Quebec; Oncology
- Cancer Hospital Chinese Academy of Medical Sciences.
- Nanfang Hospital, Southern Medical University
- The Second Affiliated Hospital of Zhejiang University College
- The 1st Affiliated Hospital of Nanchang Unversity
- Jiangsu Cancer Hospital
- Shandong Cancer Hospital; Oncology
- Fudan University Shanghai Cancer Center
- Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
- Tianjin Cancer Hospital
- Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
- Tampere University Hospital; Dept of Oncology
- Turku Uni Central Hospital; Oncology Clinics
- Hopital Louis Pasteur; Medecine B
- Hopital Claude Huriez; Medecine Interne Oncologie
- Institut Paoli Calmettes; Oncologie Medicale
- Hopital Civil; Hematologie Oncologie
- Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
- Universitaetsklinikum Halle; Klinik u.Poliklinik fuer Innere Medizin IV
- Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie
- Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
- Evangelismos Hospital; Medical Oncology
- Per. Gen. Hospital Ippokrateion; Oncology Dept.
- Univ General Hosp Heraklion; Medical Oncology
- University Hospital of Patras Medical Oncology
- Theagenio Anticancer Hospital; 3Rd Oncology Clinic
- Theageneio Anticancer Hospital; Gastroenterology
- Queen Mary Hospital; Surgery
- Ogyi, Orszagos Gyogyszereszeti Intezet
- Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X
- Orszagos Onkologial Intezet; Onkologiai Osztaly X
- Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
- Mercy Uni Hospital; Deparment of Medical Oncology
- St. James Hospital; Oncology
- Galway Uni Hospital; Oncology Dept
- Soroka Medical Center; Oncology Dept
- Rambam Medical Center; Oncology
- Shaare Zedek Medical Center; Oncology Dept
- Hadassah Ein Karem Hospital; Oncology Dept
- Meir Medical Center; Oncology
- Nahariya Hospital; Oncology
- Rabin Medical Center; Oncology Dept
- Golda Hasharon Medical Center; Oncology
- Chaim Sheba Medical Center; Oncology Dept
- Kaplan Medical Center; Oncology Inst.
- Sourasky / Ichilov Hospital; Oncology Department
- Assaf Harofeh; Oncology
- Ospedale Cervesi di Cattolica; ONCOLOGIA
- Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
- Ospedale Degli Infermi; Divisione Di Oncologia
- Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
- Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical
- Asst Papa Giovanni XXIII; Oncologia Medica
- Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
- A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica
- Ospedale Civile; Oncologia Medica
- Ospedale Civile; Unita Operativa Di Oncologia Medica
- Azienda Usl 7; Dept. Oncologico
- Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
- Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology
- Hanyang Uni Hospital; Dept. of Internal Medicine , Section of Hemato-Oncology
- Samsung Medical Centre; Division of Hematology/Oncology
- Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
- Centro Estatal de Cancerología
- Hospital Christus Muguerza Del Parque; Centro de Rehabilitacion
- Clinica de Especialidades # 30 Dr. Humberto Torres Sangines; Oncology
- Instituto Nacional De Ciencias Medicas Y Nutricion; Nefrology
- Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
- Christchurch Hospital; Dept of Oncology
- Dunedin Hospital; Oncology - Haematology Clinical Practice Group
- Palmerston North Hospital; Regional Cancer Treatment Service
- Wellington Hospital; Regional Oncology Unit
- Isthmian Medical Research Center, S.A.; Oncology
- Rydygiera Hospital; Chemotherapy
- Wojewodzki Szpital Specjalistyczny Im. M. Kopernika; Oddzial Chorob Rozrostowych
- Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii
- Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
- Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Klinika Nowotworow Jelita Grubego
- Lubuski Osrodek Onkologii, Szpital Wojewodzki; Oddzial Onkologii
- Hospital Jose Joaquim Fernandes; Unidade de Oncologia Medica
- Hospital de Santa Maria; Servico de Oncologia Medica
- IPO do Porto; Servico de Oncologia Medica
- N.N.Burdenko Main Military Clinical Hospital; Chemotherapy
- Blokhin Cancer Research Center; Combined Treatment
- Petrov Research Inst. of Oncology; Dept of Bio-Therapy & Transplantation of Bone Marrow
- St. Petersburg City Clinical Oncological Dispensary; Colorectal (Department 4)
- National University Hospital; National University Cancer Institute, Singapore (NCIS)
- National Cancer Centre; Medical Oncology
- Panorama Medical Clinic; Oncology Unit
- Hopelands Cancer Centre; Oncology
- Hopelands Cancer Centre ST. ANNES HOSPITAL; DEPT. OF ONCOLOGY
- Little Company of Mary Hospital; Mary Potter Oncology Centre
- Sandton Oncology Medical Group
- Hospital General Universitario de Elche; Servicio de Oncologia
- Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
- Hospital Universitario Reina Sofia; Servicio de Oncologia
- Hospital Universitario Son Espases
- Hospital Severo Ochoa; Servicio de Oncologia
- Hospital Universitario Puerta de Hierro; Servicio de Oncologia
- Hospital de Cruces; Servicio de Oncologia
- Hospital Univ Vall d'Hebron; Servicio de Oncologia
- Hospital Clínic i Provincial; Servicio de Hematología y Oncología
- Hospital Duran i Reynals; Oncologia
- Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
- Hospital Universitario de la Princesa; Servicio de Oncologia
- Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
- Hospital Universitario Clínico San Carlos; Servicio de Oncologia
- Hospital Universitario 12 de Octubre; Servicio de Oncologia
- Hospital Universitario La Paz; Servicio de Oncologia
- Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
- Instituto Valenciano Oncologia; Oncologia Medica
- Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
- Hospital Universitario la Fe; Servicio de Oncologia
- Universitaetsspital Basel; Onkologie
- Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
- Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery
- Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery
- Bumrungrad Hospital Foundation; Horizon Centre
- Pramongkutklao Hospital; Medicine - Medical Oncology Unit
- Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
- Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
- Srinagarind Hospital; Medical Oncology Unit
- Aberdeen Royal Infirmary; Medical Oncology Dept
- The Royal Sussex County Hospital; the Sussex Cancer Centre
- West Suffolk Hospital Nhs Trust; Gi Corridor
- Addenbrooke'S Hospital; Univ.Dept.& Mrc Unit of Clin.Oncology & Radiotherapeutics
- Derbyshire Royal Infirmary; Dept of Oncology
- Cruk Clinical Trials Unit; Level 0 Beatson West Of Scotland Cancer Ctr
- Royal Surrey County Hospital; St. Lukes Cancer Centre
- St James Institute of Oncology
- Leicester Royal Infirmary; Dept. of Medical Oncology
- St Thomas Hospital; Oncology Dept
- Royal Marsden Nhs Trust; Consultant Cancer Physician
- Hammersmith Hospital; Mrc Clinical Science Centre
- Charing Cross Hospital; Medical Oncology.
- Maidstone Hospital
- Christie Hospital; Breast Cancer Research Office
- James Cook Uni Hospital
- Northern Centre for Cancer Care;Oncology
- Mount Vernon Hospital; Centre For Cancer Treatment
- Nottingham City Hospital; Oncology
- Derriford Hospital; Plymouth Oncology Centre
- North Wales Cancer Treatment Centre, Glan Clwyd Hospital
- Salisbury District General Hospital; Medical Oncology Dept
- Southampton General Hospital; Somers Cancer Research Building
- Royal Marsden Hospital; Dept of Medical Oncology
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
5-Fluorouracil/Leucovorin (5-FU/LV)
Capecitabine in Combination with Oxaliplatin (XELOX)
Participants were given one of two regimens (each participating center prespecified which regimen they would use for all patients at that center): i) Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or; ii) Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks).
Capecitabine was administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks).