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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Capecitabine
Oxaliplatin
Leucovorin (LV)
5-Fluorouracil (5-FU)
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Experimental

Arm Label

5-Fluorouracil/Leucovorin (5-FU/LV)

Capecitabine in Combination with Oxaliplatin (XELOX)

Arm Description

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
September 15, 2003
Last Updated
February 14, 2020
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00069121
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 18, 2003 (Actual)
Primary Completion Date
April 21, 2011 (Actual)
Study Completion Date
April 21, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1886 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5-Fluorouracil/Leucovorin (5-FU/LV)
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Capecitabine in Combination with Oxaliplatin (XELOX)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
1000 milligrams per square metre of body surface area (mg/m^2) orally twice daily on days 1-15 of each 3-week cycle.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
130 mg/m^2 intravenous (IV) infusion over two hours on Day 1 of each 3-week cycle.
Intervention Type
Drug
Intervention Name(s)
Leucovorin (LV)
Intervention Description
Administered by one of two regimens, as specified in the arm description.
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil (5-FU)
Intervention Description
Administered by one of two regimens, as specified in the arm description.
Primary Outcome Measure Information:
Title
Disease-Free Survival (DFS) [Number of Events]
Description
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 Frame
Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months).
Title
Disease-Free Survival (DFS) [Time to Event]
Description
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 Frame
Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months).
Secondary Outcome Measure Information:
Title
Relapse-Free Survival (RFS) [Number of Events]
Description
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 Frame
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).
Title
Relapse-Free Survival (RFS) [Time to Event]
Description
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 Frame
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).
Title
Overall Survival [Number of Events]
Description
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 Frame
Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
Title
Overall Survival [Time to Event]
Description
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 Frame
Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
Title
Number of Participants With at Least One Adverse Event by Most Severe Intensity
Description
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.
Time Frame
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).

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
36306483
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.
Results Reference
derived
PubMed Identifier
26324362
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.
Results Reference
derived

Learn more about this trial

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

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