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

NCT ID: NCT00069121

Last Updated: 2020-03-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1886 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-18

Study Completion Date

2011-04-21

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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).

Group Type ACTIVE_COMPARATOR

Leucovorin (LV)

Intervention Type DRUG

Administered by one of two regimens, as specified in the arm description.

5-Fluorouracil (5-FU)

Intervention Type DRUG

Administered by one of two regimens, as specified in the arm description.

Capecitabine in Combination with Oxaliplatin (XELOX)

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).

Group Type EXPERIMENTAL

Capecitabine

Intervention Type DRUG

1000 milligrams per square metre of body surface area (mg/m\^2) orally twice daily on days 1-15 of each 3-week cycle.

Oxaliplatin

Intervention Type DRUG

130 mg/m\^2 intravenous (IV) infusion over two hours on Day 1 of each 3-week cycle.

Interventions

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Capecitabine

1000 milligrams per square metre of body surface area (mg/m\^2) orally twice daily on days 1-15 of each 3-week cycle.

Intervention Type DRUG

Oxaliplatin

130 mg/m\^2 intravenous (IV) infusion over two hours on Day 1 of each 3-week cycle.

Intervention Type DRUG

Leucovorin (LV)

Administered by one of two regimens, as specified in the arm description.

Intervention Type DRUG

5-Fluorouracil (5-FU)

Administered by one of two regimens, as specified in the arm description.

Intervention Type DRUG

Other Intervention Names

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Xeloda

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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The Cancer Center At Providence Park

Mobile, Alabama, United States

Site Status

Central Hematology Oncology Medical Group Inc.

Alhambra, California, United States

Site Status

Comprehensive Blood/Cancer Ctr

Bakersfield, California, United States

Site Status

Virginia K. Crossen Cancer Center

Fullerton, California, United States

Site Status

Pacific Shores Medical Group

Long Beach, California, United States

Site Status

West Valley Hematology Oncology The Thomas and Dorothy Leavey Cancer Center

Northridge, California, United States

Site Status

Ventura County Hematology-Oncology Specialists

Oxnard, California, United States

Site Status

Wilshire Oncology Medical Group

Pomona, California, United States

Site Status

Sutter Cancer Center

Sacramento, California, United States

Site Status

Scripps Cancer Center

San Diego, California, United States

Site Status

Kaiser Permanente San Diego; Hepatology Research

San Diego, California, United States

Site Status

Santa Barbara Hematology Oncology Medical Group, Inc.

Santa Barbara, California, United States

Site Status

San Diego Cancer Center'S Medical Group

Vista, California, United States

Site Status

Innovative clinical research institute/American institute of research

Whittier, California, United States

Site Status

University of Colorado Health Science Center; Biomedical Research Bldg. Room 511

Aurora, Colorado, United States

Site Status

Hematology Oncology Associates

Fort Collins, Colorado, United States

Site Status

Hematology Oncology P.C.

Stamford, Connecticut, United States

Site Status

Georgetown Uni Medical Center; Lombardi Cancer Center

Washington D.C., District of Columbia, United States

Site Status

Lakeland Regional Cancer Center

Lakeland, Florida, United States

Site Status

Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Site Status

Georgia Cancer Specialists

Atlanta, Georgia, United States

Site Status

Illinois Cancer Care

Peoria, Illinois, United States

Site Status

Hope Center

Terre Haute, Indiana, United States

Site Status

Ochsner Cancer Inst.

New Orleans, Louisiana, United States

Site Status

Park Nicollet Clinic Cancer Center

Saint Louis Park, Minnesota, United States

Site Status

St Joseph Oncology

Saint Joseph, Missouri, United States

Site Status

Hematology Oncology Consultants, Inc.

St Louis, Missouri, United States

Site Status

Hematology-Oncology Centers of the Northern Rockies

Billings, Montana, United States

Site Status

Great Falls Clinic

Great Falls, Montana, United States

Site Status

Va Medical Center

Reno, Nevada, United States

Site Status

Nh Oncology Hematology, Pa

Hooksett, New Hampshire, United States

Site Status

Morristown Medical Center;Hematology-Oncology Assoc

Morristown, New Jersey, United States

Site Status

Overlook Oncology Center; Summit Medical Group

Summit, New Jersey, United States

Site Status

New Mexico Oncology Hematology Consultants

Albuquerque, New Mexico, United States

Site Status

St. Vincent'S Hospital; Comprehensive Care Center

New York, New York, United States

Site Status

Presbyterian Healthcare; Cancer Research Dept

Charlotte, North Carolina, United States

Site Status

Moses Cone Reg Cancer Ctr

Greensboro, North Carolina, United States

Site Status

Carolina Oncology Specialists, PA - Hickory

Hickory, North Carolina, United States

Site Status

Oncology-Hematology of Lehigh Valley, Pc

Bethlehem, Pennsylvania, United States

Site Status

Medical Oncology Associates

Kingston, Pennsylvania, United States

Site Status

Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase-Temple Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Uni of Pittsburgh Cancer Inst. ; Oncology

Pittsburgh, Pennsylvania, United States

Site Status

West Clinic

Germantown, Tennessee, United States

Site Status

US Oncology

The Woodlands, Texas, United States

Site Status

Intermountain Hematology & Oncology

Salt Lake City, Utah, United States

Site Status

Internal Medicine Associates of Yakima Inc.

Yakima, Washington, United States

Site Status

UNI OF WISCONSIN SCHOOL OF MEDICINE; GI Oncology Research Group, Paul P Carbone Cancer Center

Madison, Wisconsin, United States

Site Status

Royal Prince Alfred Hospital; Medical Oncology

Camperdown, New South Wales, Australia

Site Status

Port Macquarie Base Hospital; Oncology

Port Macquarie, New South Wales, Australia

Site Status

Southern Medical Day Care; Clinical Trials Unit

Wollongong, New South Wales, Australia

Site Status

Queen Elizabeth Hospital; Medical Oncology

Woodville South, South Australia, Australia

Site Status

Box Hill Hospital; Oncology

Box Hill, Victoria, Australia

Site Status

Footscray Hospital

Footscray, Victoria, Australia

Site Status

St John of God Hospital; Medical Oncology

Perth, Western Australia, Australia

Site Status

Cliniques Universitaires St-Luc

Brussels, , Belgium

Site Status

GHdC Site Notre Dame

Charleroi, , Belgium

Site Status

UZ Gent

Ghent, , Belgium

Site Status

AZ Groeninge

Kortrijk, , Belgium

Site Status

UZ Leuven Gasthuisberg

Leuven, , Belgium

Site Status

Hospital de Baleia; Serviço de Oncologia Clínica

Belo Horizonte, Minas Gerais, Brazil

Site Status

Hospital Amaral Carvalho

Jaú, São Paulo, Brazil

Site Status

Hospital das Clinicas - FMUSP; Gastroenterologia

São Paulo, São Paulo, Brazil

Site Status

Tom Baker Cancer Centre; Dept of Medicine

Calgary, Alberta, Canada

Site Status

Cross Cancer Institute ; Dept of Medical Oncology

Edmonton, Alberta, Canada

Site Status

Bcca - Cancer Center Southern Interior

Kelowna, British Columbia, Canada

Site Status

Bcca-Fraser Valley Cancer Centre

Surrey, British Columbia, Canada

Site Status

Bcca - Vancouver Island Cancer Centre; Oncology

Victoria, British Columbia, Canada

Site Status

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Site Status

Dr. H. Bliss Murphy Cancer Centre; Oncology

St. John's, Newfoundland and Labrador, Canada

Site Status

Queen Elizabeth II Health Sciences Centre; Oncology

Halifax, Nova Scotia, Canada

Site Status

Hamilton Health Sciences - Juravinski Cancer Centre

Hamilton, Ontario, Canada

Site Status

London Regional Cancer Centre

London, Ontario, Canada

Site Status

Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre

Mississauga, Ontario, Canada

Site Status

Lakeridge Health Oshawa; Oncology

Oshawa, Ontario, Canada

Site Status

The Ottawa Hospital Cancer Centre; Oncology

Ottawa, Ontario, Canada

Site Status

Humber River Hospital

Toronto, Ontario, Canada

Site Status

Sunnybrook Health Science Centre

Toronto, Ontario, Canada

Site Status

University Health Network; Princess Margaret Hospital; Medical Oncology Dept

Toronto, Ontario, Canada

Site Status

Cite de La Sante de Laval; Hemato-Oncologie

Laval, Quebec, Canada

Site Status

Hotel Dieu de Levis; Oncology

Lévis, Quebec, Canada

Site Status

Hopital Maisonneuve- Rosemont; Oncology

Montreal, Quebec, Canada

Site Status

Chum Campus Notre Dame

Montreal, Quebec, Canada

Site Status

McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

Montreal, Quebec, Canada

Site Status

Hopital Du Sacre Coeur de Montreal; Pneumologie

Montreal, Quebec, Canada

Site Status

Chuq - Hopital Hotel Dieu de Quebec; Oncology

Québec, Quebec, Canada

Site Status

Cancer Hospital Chinese Academy of Medical Sciences.

Beijing, , China

Site Status

Nanfang Hospital, Southern Medical University

Guangzhou, , China

Site Status

The Second Affiliated Hospital of Zhejiang University College

Hangzhou, , China

Site Status

The 1st Affiliated Hospital of Nanchang Unversity

Nanchang, , China

Site Status

Jiangsu Cancer Hospital

Nanjing, , China

Site Status

Shandong Cancer Hospital; Oncology

Shandong, , China

Site Status

Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

Shanghai, , China

Site Status

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status

Tianjin Cancer Hospital

Tianjin, , China

Site Status

Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

Wuhan, , China

Site Status

Tampere University Hospital; Dept of Oncology

Tampere, , Finland

Site Status

Turku Uni Central Hospital; Oncology Clinics

Turku, , Finland

Site Status

Hopital Louis Pasteur; Medecine B

Colmar, , France

Site Status

Hopital Claude Huriez; Medecine Interne Oncologie

Lille, , France

Site Status

Institut Paoli Calmettes; Oncologie Medicale

Marseille, , France

Site Status

Hopital Civil; Hematologie Oncologie

Strasbourg, , France

Site Status

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

Freiburg im Breisgau, , Germany

Site Status

Universitaetsklinikum Halle; Klinik u.Poliklinik fuer Innere Medizin IV

Halle, , Germany

Site Status

Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie

Magdeburg, , Germany

Site Status

Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

Trier, , Germany

Site Status

Evangelismos Hospital; Medical Oncology

Athens, , Greece

Site Status

Per. Gen. Hospital Ippokrateion; Oncology Dept.

Athens, , Greece

Site Status

Univ General Hosp Heraklion; Medical Oncology

Heraklion, , Greece

Site Status

University Hospital of Patras Medical Oncology

Pátrai, , Greece

Site Status

Theagenio Anticancer Hospital; 3Rd Oncology Clinic

Thessaloniki, , Greece

Site Status

Theageneio Anticancer Hospital; Gastroenterology

Thessaloniki, , Greece

Site Status

Queen Mary Hospital; Surgery

Hong Kong, , Hong Kong

Site Status

Ogyi, Orszagos Gyogyszereszeti Intezet

Budapest, , Hungary

Site Status

Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X

Budapest, , Hungary

Site Status

Orszagos Onkologial Intezet; Onkologiai Osztaly X

Budapest, , Hungary

Site Status

Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

Szeged, , Hungary

Site Status

Mercy Uni Hospital; Deparment of Medical Oncology

Cork, , Ireland

Site Status

St. James Hospital; Oncology

Dublin, , Ireland

Site Status

Galway Uni Hospital; Oncology Dept

Galway, , Ireland

Site Status

Soroka Medical Center; Oncology Dept

Beersheba, , Israel

Site Status

Rambam Medical Center; Oncology

Haifa, , Israel

Site Status

Shaare Zedek Medical Center; Oncology Dept

Jerusalem, , Israel

Site Status

Hadassah Ein Karem Hospital; Oncology Dept

Jerusalem, , Israel

Site Status

Meir Medical Center; Oncology

Kfar Saba, , Israel

Site Status

Nahariya Hospital; Oncology

Nahariya, , Israel

Site Status

Rabin Medical Center; Oncology Dept

Petah Tikva, , Israel

Site Status

Golda Hasharon Medical Center; Oncology

Petah Tikva, , Israel

Site Status

Chaim Sheba Medical Center; Oncology Dept

Ramat Gan, , Israel

Site Status

Kaplan Medical Center; Oncology Inst.

Rehovot, , Israel

Site Status

Sourasky / Ichilov Hospital; Oncology Department

Tel Aviv, , Israel

Site Status

Assaf Harofeh; Oncology

Ẕerifin, , Israel

Site Status

Ospedale Cervesi di Cattolica; ONCOLOGIA

Cattolica, Emilia-Romagna, Italy

Site Status

Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

Parma, Emilia-Romagna, Italy

Site Status

Ospedale Degli Infermi; Divisione Di Oncologia

Rimini, Emilia-Romagna, Italy

Site Status

Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

Udine, Friuli Venezia Giulia, Italy

Site Status

Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical

Genoa, Liguria, Italy

Site Status

Asst Papa Giovanni XXIII; Oncologia Medica

Bergamo, Lombardy, Italy

Site Status

Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

Milan, Lombardy, Italy

Site Status

Ospedale Civile; Oncologia Medica

Sassari, Sardinia, Italy

Site Status

A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica

Ancona, The Marches, Italy

Site Status

Ospedale Civile; Unita Operativa Di Oncologia Medica

Livorno, Tuscany, Italy

Site Status

Azienda Usl 7; Dept. Oncologico

Poggibonsi, Tuscany, Italy

Site Status

Centro Estatal de Cancerología

Chihuahua City, , Mexico

Site Status

Hospital Christus Muguerza Del Parque; Centro de Rehabilitacion

Chihuahua City, , Mexico

Site Status

Clinica de Especialidades # 30 Dr. Humberto Torres Sangines; Oncology

Mexicali, , Mexico

Site Status

Instituto Nacional De Ciencias Medicas Y Nutricion; Nefrology

Mexico City, , Mexico

Site Status

Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

Auckland, , New Zealand

Site Status

Christchurch Hospital; Dept of Oncology

Christchurch, , New Zealand

Site Status

Dunedin Hospital; Oncology - Haematology Clinical Practice Group

Dunedin, , New Zealand

Site Status

Palmerston North Hospital; Regional Cancer Treatment Service

Palmerston North, , New Zealand

Site Status

Wellington Hospital; Regional Oncology Unit

Wellington, , New Zealand

Site Status

Isthmian Medical Research Center, S.A.; Oncology

Panama City, , Panama

Site Status

Rydygiera Hospital; Chemotherapy

Krakow, , Poland

Site Status

Wojewodzki Szpital Specjalistyczny Im. M. Kopernika; Oddzial Chorob Rozrostowych

Lodz, , Poland

Site Status

Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii

Poznan, , Poland

Site Status

Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

Szczecin, , Poland

Site Status

Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Klinika Nowotworow Jelita Grubego

Warsaw, , Poland

Site Status

Lubuski Osrodek Onkologii, Szpital Wojewodzki; Oddzial Onkologii

Zielona Góra, , Poland

Site Status

Hospital Jose Joaquim Fernandes; Unidade de Oncologia Medica

Beja, , Portugal

Site Status

Hospital de Santa Maria; Servico de Oncologia Medica

Lisbon, , Portugal

Site Status

IPO do Porto; Servico de Oncologia Medica

Porto, , Portugal

Site Status

N.N.Burdenko Main Military Clinical Hospital; Chemotherapy

Moscow, , Russia

Site Status

Blokhin Cancer Research Center; Combined Treatment

Moscow, , Russia

Site Status

Petrov Research Inst. of Oncology; Dept of Bio-Therapy & Transplantation of Bone Marrow

Saint Petersburg, , Russia

Site Status

St. Petersburg City Clinical Oncological Dispensary; Colorectal (Department 4)

Saint Petersburg, , Russia

Site Status

National University Hospital; National University Cancer Institute, Singapore (NCIS)

Singapore, , Singapore

Site Status

National Cancer Centre; Medical Oncology

Singapore, , Singapore

Site Status

Panorama Medical Clinic; Oncology Unit

Cape Town, , South Africa

Site Status

Hopelands Cancer Centre; Oncology

Durban, , South Africa

Site Status

Hopelands Cancer Centre ST. ANNES HOSPITAL; DEPT. OF ONCOLOGY

Pietermaritzburg, , South Africa

Site Status

Little Company of Mary Hospital; Mary Potter Oncology Centre

Pretoria, , South Africa

Site Status

Sandton Oncology Medical Group

Sandton, , South Africa

Site Status

Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

Seoul, , South Korea

Site Status

Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology

Seoul, , South Korea

Site Status

Hanyang Uni Hospital; Dept. of Internal Medicine , Section of Hemato-Oncology

Seoul, , South Korea

Site Status

Samsung Medical Centre; Division of Hematology/Oncology

Seoul, , South Korea

Site Status

Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

Seoul, , South Korea

Site Status

Hospital General Universitario de Elche; Servicio de Oncologia

Elche, Alicante, Spain

Site Status

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Site Status

Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

Santander, Cantabria, Spain

Site Status

Hospital Universitario Reina Sofia; Servicio de Oncologia

Córdoba, Cordoba, Spain

Site Status

Hospital Severo Ochoa; Servicio de Oncologia

Leganés, Madrid, Spain

Site Status

Hospital Universitario Puerta de Hierro; Servicio de Oncologia

Majadahonda, Madrid, Spain

Site Status

Hospital de Cruces; Servicio de Oncologia

Bilbao, Vizcaya, Spain

Site Status

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, , Spain

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Hospital Clínic i Provincial; Servicio de Hematología y Oncología

Barcelona, , Spain

Site Status

Hospital Duran i Reynals; Oncologia

Barcelona, , Spain

Site Status

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

Jaén, , Spain

Site Status

Hospital Universitario de la Princesa; Servicio de Oncologia

Madrid, , Spain

Site Status

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

Madrid, , Spain

Site Status

Hospital Universitario Clínico San Carlos; Servicio de Oncologia

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, , Spain

Site Status

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, , Spain

Site Status

Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

Málaga, , Spain

Site Status

Instituto Valenciano Oncologia; Oncologia Medica

Valencia, , Spain

Site Status

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

Valencia, , Spain

Site Status

Hospital Universitario la Fe; Servicio de Oncologia

Valencia, , Spain

Site Status

Universitaetsspital Basel; Onkologie

Basel, , Switzerland

Site Status

Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

Taipei, , Taiwan

Site Status

Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery

Taipei, , Taiwan

Site Status

Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery

Taoyuan District, , Taiwan

Site Status

Bumrungrad Hospital Foundation; Horizon Centre

Bangkok, , Thailand

Site Status

Pramongkutklao Hospital; Medicine - Medical Oncology Unit

Bangkok, , Thailand

Site Status

Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

Bangkok, , Thailand

Site Status

Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

Bangkok, , Thailand

Site Status

Srinagarind Hospital; Medical Oncology Unit

Khon Kaen, , Thailand

Site Status

Aberdeen Royal Infirmary; Medical Oncology Dept

Aberdeen, , United Kingdom

Site Status

The Royal Sussex County Hospital; the Sussex Cancer Centre

Brighton, , United Kingdom

Site Status

West Suffolk Hospital Nhs Trust; Gi Corridor

Bury St Edmunds, , United Kingdom

Site Status

Addenbrooke'S Hospital; Univ.Dept.& Mrc Unit of Clin.Oncology & Radiotherapeutics

Cambridge, , United Kingdom

Site Status

Derbyshire Royal Infirmary; Dept of Oncology

Derby, , United Kingdom

Site Status

Cruk Clinical Trials Unit; Level 0 Beatson West Of Scotland Cancer Ctr

Glasgow, , United Kingdom

Site Status

Royal Surrey County Hospital; St. Lukes Cancer Centre

Guildford, , United Kingdom

Site Status

St James Institute of Oncology

Leeds, , United Kingdom

Site Status

Leicester Royal Infirmary; Dept. of Medical Oncology

Leicester, , United Kingdom

Site Status

St Thomas Hospital; Oncology Dept

London, , United Kingdom

Site Status

Royal Marsden Nhs Trust; Consultant Cancer Physician

London, , United Kingdom

Site Status

Hammersmith Hospital; Mrc Clinical Science Centre

London, , United Kingdom

Site Status

Charing Cross Hospital; Medical Oncology.

London, , United Kingdom

Site Status

Maidstone Hospital

Maidstone, , United Kingdom

Site Status

Christie Hospital; Breast Cancer Research Office

Manchester, , United Kingdom

Site Status

James Cook Uni Hospital

Middlesbrough, , United Kingdom

Site Status

Northern Centre for Cancer Care;Oncology

Newcastle upon Tyne, , United Kingdom

Site Status

Mount Vernon Hospital; Centre For Cancer Treatment

Northwood, , United Kingdom

Site Status

Nottingham City Hospital; Oncology

Nottingham, , United Kingdom

Site Status

Derriford Hospital; Plymouth Oncology Centre

Plymouth, , United Kingdom

Site Status

North Wales Cancer Treatment Centre, Glan Clwyd Hospital

Rhyl, , United Kingdom

Site Status

Salisbury District General Hospital; Medical Oncology Dept

Salisbury, , United Kingdom

Site Status

Southampton General Hospital; Somers Cancer Research Building

Southampton, , United Kingdom

Site Status

Royal Marsden Hospital; Dept of Medical Oncology

Sutton, , United Kingdom

Site Status

Countries

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

References

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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.

Reference Type DERIVED
PMID: 36306483 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26324362 (View on PubMed)

Other Identifiers

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NO16968

Identifier Type: -

Identifier Source: org_study_id

NCT00080691

Identifier Type: -

Identifier Source: nct_alias

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