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Capecitabine Compared With Fluorouracil Plus Leucovorin in Treating Patients Who Have Undergone Surgery for Stage III Colon Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Capecitabine Compared With Fluorouracil Plus Leucovorin in Treating Patients Who Have Undergone Surgery for Stage III Colon Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Capecitabine Compared With Fluorouracil Plus Leucovorin in Treating Patients Who Have Undergone Surgery for Stage III Colon Cancer Clinical research trials and Capecitabine Compared With Fluorouracil Plus Leucovorin in Treating Patients Who Have Undergone Surgery for Stage III Colon Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Capecitabine Compared With Fluorouracil Plus Leucovorin in Treating Patients Who Have Undergone Surgery for Stage III Colon Cancer. Capecitabine Compared With Fluorouracil Plus Leucovorin in Treating Patients Who Have Undergone Surgery for Stage III Colon Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Capecitabine Compared With Fluorouracil Plus Leucovorin in Treating Patients Who Have Undergone Surgery for Stage III Colon Cancer clinical trial. Subjects frequently get the best healthcare possible for their Capecitabine Compared With Fluorouracil Plus Leucovorin in Treating Patients Who Have Undergone Surgery for Stage III Colon Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.

Home > "C" Clinical Trials Conditions > Capecitabine Compared With Fluorouracil Plus Leucovorin in Treating Patients Who Have Undergone Surgery for Stage III Colon Cancer

Capecitabine Compared With Fluorouracil Plus Leucovorin in Treating Patients Who Have Undergone Surgery for Stage III Colon Cancer



Capecitabine Compared With Fluorouracil Plus Leucovorin in Treating Patients Who Have Undergone Surgery for Stage III Colon Cancer

For Condition: stage 3 colon cancer
Status: No longer recruiting
Sponsor(s): Hoffmann-La Roche ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective in treating colon cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of capecitabine with that of fluorouracil plus leucovorin in treating patients who have undergone surgery for stage III colon cancer.
Details: OBJECTIVES: I. Compare adjuvant capecitabine versus fluorouracil and low-dose leucovorin calcium in terms of disease-free survival in chemotherapy naive patients with previously resected stage III colon cancer. II. Compare the overall survival of this patient population treated with these regimens. III. Compare the safety profile of these treatment regimens in this patient population. IV. Compare the quality of life in this patient population treated with these regimens. V. Compare medical care utilization in this patient population treated with these regimens. PROTOCOL OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral capecitabine twice daily for two weeks. Treatment repeats every 3 weeks for 8 courses. Arm II: Patients receive low-dose leucovorin calcium IV followed by fluorouracil IV on days 1-5. Treatment repeats every 4 weeks for 6 courses. Quality of life is assessed at baseline, at weeks 7, 16, and 25 (arm I), and at weeks 9, 17, and 25 (arm II). Patients are followed every 6 months for 2 years and then annually for 3 years. PROJECTED ACCRUAL: A total of 1,956 (978 per treatment arm) will be accrued for this study within 2.3 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage III (Dukes C) colon carcinoma; At least 1 positive lymph node - Potentially curative prior resection of tumor within 8 weeks of study; No macroscopic and microscopic evidence of remaining tumor - Chemotherapy naive --Prior/Concurrent Therapy-- - Biologic therapy: No prior immunotherapy; No concurrent active or passive immunotherapy (i.e., 17-1A antibody) for colon cancer - Chemotherapy: See Disease Characteristics; No other concurrent cytotoxic agents - Endocrine therapy: Prior steroids allowed - Radiotherapy: No concurrent radiotherapy - Surgery: See Disease Characteristics; No prior laparoscopic surgery for colon carcinoma Recovered from prior surgery; No organ allografts - Other: At least 4 weeks since prior participation in any investigational drug study; No other concurrent investigational drugs --Patient Characteristics-- - Age: 18 to 75 - Performance status: Karnofsky 70-100% OR ECOG 0-1 - Life expectancy: At least 5 years - Hematopoietic: Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); ALT/AST no greater than 2.5 times ULN; Alkaline phosphatase no greater than 2.5 times ULN - Renal: Creatinine no greater than 1.5 times ULN - Cardiovascular: No significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or uncontrolled cardiac arrhythmia); No myocardial infarction within the past 12 months - Other: No history of uncontrolled seizures, central nervous system disorders, or psychiatric disability that would preclude study; No other malignancy within the past 5 years except for cured basal cell skin cancer or carcinoma in situ of the cervix; No serious uncontrolled infection; No lack of physical integrity of the upper gastrointestinal tract; No malabsorption syndrome; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
StefanFrings,  Study Chair,  Hoffmann-La Roche

CHR de Grenoble - La Tronche
Grenoble,  ,  38043
France
 

Inselspital, Bern
Bern,  ,  CH-3010
Switzerland
 

Aberdeen Royal Infirmary
Aberdeen,  Scotland,  AB25 2ZN
United Kingdom
 

Bezirkskrankenhaus Hall in Tirol
Hall in Tirol,  ,  A-6060
Austria
 

Klinikem St. Antonius
Wuppertal 2,  ,  D-42283
Germany
 

Tumor Biology Center at the Albert-Ludwigs University
Freiburg,  ,  D-79106
Germany
 

Klinikum der Universitaet Regensburg
Regensburg,  ,  D-93053
Germany
 

Klinikum Kassel/Hautklinik
Kassel,  ,  D-34125
Germany
 

Hospital Clinico Universitario de Valencia
Valencia,  ,  46010
Spain
 

CHR Hotel Dieu
Nantes,  ,  44093
France
 

Ospedali Riuniti di Bergamo
Bergamo,  ,  24100
Italy
 

Derriford Hospital
Plymouth,  England,  PL6 8DH
United Kingdom
 

Queen Elizabeth Hospital
Gateshead,  England,  NE9 6SX
United Kingdom
 

East Texas Medical Center Cancer Institute
Tyler,  Texas,  75701
United States
 

Nemocnice Ceske Budejovice
Budejovice,  ,  370 87C
Czech Republic
 

Krankenhaus der Elisabethinen
Linz,  ,  4020
Austria
 

Georgia Cancer Specialists
Decatur,  Georgia,  30033
United States
 

Hospital Escolar San Joao
Porto,  ,  4200
Portugal
 

U.O.A. Oncologia Medica
Turin (Torino),  ,  10126
Italy
 

Belfast City Hospital Trust
Belfast,  Northern Ireland,  BT9 7AB
United Kingdom
 

Beatson Oncology Centre
Glasgow,  Scotland,  G11 6NT
United Kingdom
 

Instituto de Oncologia de Soracaba
Sorocaba,  Sao Paulo,  18030--200
Brazil
 

Royal Infirmary
Glasgow,  Scotland,  G4 0SF
United Kingdom
 

A.O. Krankenhaus der Landeshauptstadt
St. Poelten,  ,  A-3100
Austria
 

Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels (Bruxelles),  ,  1090
Belgium
 

Jagiellonian University
Krakow (Cracow),  ,  31-826
Poland
 

Hospital Clinico
Madrid,  ,  28040
Spain
 

Institut J. Paoli and I. Calmettes
Marseille,  ,  13273
France
 

Hopital de Gastroenterologia Dr. Bonorino Udaondo
Buenos Aires,  ,  1264
Argentina
 

Cancer Center of Albany Medical Center
Albany,  New York,  12208
United States
 

Hospital Chomutov
Chomutov,  ,  430 12
Czech Republic
 

Azienda Ospedaliera S. Maria
Terni,  ,  05100
Italy
 

Ospedale St. Santa Chiara
Pisa,  ,  56100
Italy
 

St. Boniface General Hospital
Winnipeg,  Manitoba,  R2H 2A6
Canada
 

Theagenio Hospital
THESSALONIKI,  ,  54007
Greece
 

Hospital de Basurto
Bilbao (Vizcaya),  ,  48013
Spain
 

Krankenanstalt Rudolfstiftung
Vienna (Wien),  ,  A-1030
Austria
 

Centro Hospitalar de Coimbra
Coimbra,  ,  3040-316
Portugal
 

Ashford Cancer Centre
Ashford,  South Australia,  5035
Australia
 

Hopital L'Archet - 2
Nice,  ,  F-06202
France
 

Hospital Son Dureta
Palma de Mallorca,  ,  07014
Spain
 

Donauspital im SMZ-Ost der Stadt Wien
Wien,  ,  A-1220
Austria
 

Kaplan Hospital
Rehovot,  ,  76100
Israel
 

Ospedale San Bortolo
Vicenza,  ,  36100
Italy
 

University Hospital of Linkoping
Linkoping,  ,  S-581 85
Sweden
 

Mount Hospital
Perth,  Western Australia,  6000
Australia
 

Office of Burkhard Otremba
Oldenburg,  ,  26121
Germany
 

University Hospital
Basel,  ,  CH-4031
Switzerland
 

Cleveland Clinic Taussig Cancer Center
Cleveland,  Ohio,  44195
United States
 

Medizinische Universitaet Luebeck
Luebeck,  ,  D-23538
Germany
 

Mount Vernon Hospital
Northwood,  England,  HA6 2RN
United Kingdom
 

Clinica De Oncologia Medica S/C LTDA
Sao Paulo,  ,  SP 01406
Brazil
 

Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia,  ,  4434-502
Portugal
 

Istituti Fisioterapici Ospitalieri - Roma
Rome,  ,  00161
Italy
 

Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre,  Rio Grande do Sul,  90020--090
Brazil
 

Hospital de la Princesa
Madrid,  ,  28006
Spain
 

Alfred Hospital
Melbourne,  Victoria,  3181
Australia
 

Onkologicka Klinika FN Hradec Kralove
HRADEC KRALOVE,  ,  500 36
Czech Republic
 

University Hospital Rebro
Zagreb,  ,  41000
Croatia
 

Ospedale San Filippo Neri
Rome,  ,  00135
Italy
 

St. Luke's Cancer Center
Guildford,  England,  AU2 7XX
United Kingdom
 

Kaiser Franz Josef Hospital
Vienna (Wien),  ,  A-1100
Austria
 

Southwest Regional Cancer Center
Austin,  Texas,  78705
United States
 

Clinique Sainte Catherine
Avignon,  ,  84082
France
 

Instituto Portugues de Oncologia do Porto
Porto,  ,  4200
Portugal
 

Ellis Fischel Cancer Center - Columbia
Columbia,  Missouri,  65203
United States
 

Hospitais da Universidade de Coimbra (HUC)
Coimbra,  ,  3049
Portugal
 

Clinic of Oncology
Boras,  ,  S-501 02
Sweden
 

Hospital "Dr. Manuel Quintela"
Montevideo,  ,  11600
Uruguay
 

Regional Center of Oncology
Bydgoszcz,  ,  85-796
Poland
 

Centre Paul Papin
Angers,  ,  49036
France
 

Ryhov Hospital
Jonkoping,  ,  S-551 85
Sweden
 

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw,  ,  02-781
Poland
 

Tom Baker Cancer Center - Calgary
Calgary,  Alberta,  T2N 4N2
Canada
 

Tel-Aviv Sourasky Medical Center
Tel Aviv,  ,  64239
Israel
 

Universita di Modena
Modena,  ,  41100
Italy
 

Instituto Portugues de Oncologia de Francisco Gentil
Lisbon,  ,  1093
Portugal
 

Onkologicka Klinka A Onkologicka Lab
Prague,  ,  128 08
Czech Republic
 

National Cancer Institute - Bratislava
Bratislava,  ,  833 10
Slovakia
 

A.O. Krankenhaus
Oberwart,  ,  A-7400
Austria
 

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome,  ,  00168
Italy
 

Christie Hospital N.H.S. Trust
Manchester,  England,  M20 4BX
United Kingdom
 

Roswell Park Cancer Institute
Buffalo,  New York,  14263-0001
United States
 

Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova),  ,  16132
Italy
 

Salisbury District Hospital
Salisbury,  ,  SP2 8BJ
United Kingdom
 

Muenchen Onkol. Praxis Elisenhof
Munich (Muenchen),  ,  D-80335
Germany
 

Staedtisches Klinikum Magdeburg
Magdeburg,  ,  D-39002
Germany
 

Ahepa University Hospital
THESSALONIKI,  ,  54636
Greece
 

Carlo Poma Hospital
Mantova,  ,  46100
Italy
 

Veterans Affairs Medical Center - West Haven
West Haven,  Connecticut,  06516
United States
 

Bendigo Hospital
Bendigo,  Victoria,  3550
Australia
 

University Hospital of Heraklion
Iraklion (Heraklion),  Crete,  71110
Greece
 

Hospital Nacional Prof. Alejandro Posadas
Buenos Aires,  ,  1706
Argentina
 

Virga Jesse Ziekenhuis
Hasselt,  ,  3500
Belgium
 

Royal South Hants Hospital
Southampton,  England,  SO14 0YG
United Kingdom
 

Royal Brisbane Hospital
Brisbane,  Queensland,  4029
Australia
 

Virchow Klinikum Humboldt Universitaet Berlin
Berlin,  ,  D-13353
Germany
 

Hospital Virgen de la Arrixaca
El Palmar (Murcia),  ,  30120
Spain
 

Ag. Anargiri Anticancer Hospital
EIAA ILION,  ,  13122
Greece
 

Velindre Hospital
Cardiff,  Wales,  CF4 7XL
United Kingdom
 

Rabin Medical Center
Petach Tikva,  ,  49100
Israel
 

Box Hill Hospital
Box Hill,  Victoria,  3128
Australia
 

Hospital Universitario de Elche
Elche Alicante,  ,  E-03203
Spain
 

Radiotherapy Institute
Ostrava-Poruba,  ,  708 52
Czech Republic
 

Kantonsspital - St. Gallen
St. Gallen,  ,  CH-9007
Switzerland
 

Hospital Geral de Santo Antonio
Porto,  ,  4050
Portugal
 

Rambam Medical Center
Haifa,  ,  31096
Israel
 

Internistisch - Onkologische Gemeinschaftspraxis
Halle,  ,  D-06110
Germany
 

Residencia Sanitaria de Jaen
Jaen,  ,  23007
Spain
 

Ospedale Fatebene Fratelli
Milano (Milan),  ,  20152
Italy
 

Hospital De Navarra
Pamplona,  ,  31080
Spain
 

Maritime Hospital
Gdynia,  ,  PL-81--519
Poland
 

Instituto de Oncologia Angel H. Roffo
Buenos Aires,  ,  1417
Argentina
 

Great Poland Cancer Center
Poznan,  ,  61 866
Poland
 

Saskatoon Cancer Centre
Saskatoon,  Saskatchewan,  S7N 4H4
Canada
 

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier,  ,  34298
France
 

CRLCC Nantes - Atlantique
Nantes-Saint Herblain,  ,  44805
France
 

USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles,  California,  90033-0804
United States
 

University Hospital Sestre Milosrdnice
Zagreb,  ,  10000
Croatia
 

Ospedale Civile San Giovanni e Paolo
Venezia,  ,  30122
Italy
 

Regional Hospital of Oncology
Szczecin,  ,  71-730
Poland
 

Umea Universitet
Umea,  ,  S-901 85
Sweden
 

Morgagni-Pierantoni Ospedale
Forli,  ,  47100
Italy
 

Pacific Coast Hematology/Oncology Medical Group
Fountain Valley,  California,  92708
United States
 

Univ. Klinik f. Chirurgie
Innsbruck,  ,  6020
Austria
 

Queen Elizabeth Hospital
Woodville,  South Australia,  5011
Australia
 

St. Vincent's Hospital
Fitzroy,  Victoria,  3065
Australia
 

Hopital de la Cavale Blanche
Brest,  ,  29609
France
 

Office of Barbara Tschechne
Lehrte,  ,  31275
Germany
 

Hopital Louis Pasteur
Colmar,  ,  68024
France
 

Sahlgrenska University Hospital
Gothenburg (Goteborg),  ,  S-413 45
Sweden
 

Ospedale Civile P.F. Calvi
Venezia,  , 
Italy
 

Hospital Universarito "Reina Sofia"
Cordoba,  ,  14004
Spain
 

Clinical Hospital Center Split
Split,  ,  21000
Croatia
 

Institute of Oncology and Radiology of Serbia
Belgrade,  ,  11000
Yugoslavia
 

Wilhelminenspital der Stadt Wien
Vienna (Wien),  ,  A-1160
Austria
 

Sarah Cannon-Minnie Pearl Cancer Center
Nashville,  Tennessee,  37203
United States
 

Luton and Dunstable Hospital
Luton-Bedfordshire,  England,  LU4 0DZ
United Kingdom
 

Murray Valley Private Hospital
Wodonga,  Victoria,  3690
Australia
 

Ottawa Regional Cancer Centre - General Campus
Ottawa,  Ontario,  K1H 1C4
Canada
 

Maria Sklodowska-Curie M.C.C.I.O. Krakow
Krakow (Cracow),  ,  31-115
Poland
 

Hospital General Gregorio Maranon
Madrid,  ,  28007
Spain
 

Office of Gunta Purkalne
Riga,  ,  LV-1002
Latvia
 

Ospedale Civile di Livorno
Livorno,  ,  57121
Italy
 

Ospedale Santa Croce
Cuneo,  ,  12100
Italy
 

Ospedale San Orsola
Bologna,  ,  40138
Italy
 

Hospital Santa Maria
Lisbon (Lisboa),  ,  1699
Portugal
 

Universitaetsspital
Zurich,  ,  CH-8091
Switzerland
 

Royal North Shore Hospital
St. Leonards,  New South Wales,  2065
Australia
 

St. John's Mercy Medical Center
St. Louis,  Missouri,  63141
United States
 

Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples (Napoli),  ,  80131
Italy
 

Montreal General Hospital
Montreal,  Quebec,  H3G 1A4
Canada
 

Teaching Hospital Plzen
Plzen,  ,  305 99
Czech Republic
 

Ospedale San Eugenio
Rome,  ,  00144
Italy
 

Hopital Edouard Herriot
Lyon,  ,  69437
France
 

Institute of Oncology, Ljubljana
LJUBLJANA,  ,  Sl-1000
Slovenia
 

University of Pennsylvania Cancer Center
Philadelphia,  Pennsylvania,  19104-4283
United States
 

St. George Hospital
Sydney,  New South Wales,  2217
Australia
 

Dipartimente di Oncologia di Torino
Turin (Torino),  ,  10123
Italy
 

University Hospitals of Leicester
Leicester,  England,  LE1 5WW
United Kingdom
 

Centro di Riferimento Oncologico - Aviano
Aviano,  ,  33081
Italy
 

Oncoserv
Rio de Janeiro,  ,  22221--080
Brazil
 

Western General Hospital
Edinburgh,  Scotland,  EH4 9NQ
United Kingdom
 

BCCC - Cancer Center for the Southern Interior
Kelowna,  British Columbia,  V1Y 5L3
Canada
 

Clinica Puerta de Hierro
Madrid,  ,  28035
Spain
 

Krankenhaus des Landes Kaernten/Institut fuer Strahlentherapie/Radioonkolopie
Klagenfurt,  ,  9026
Austria
 

Sir Charles Gairdner Hospital, Perth
Perth,  Western Australia,  6009
Australia
 

Ospedale San Giovanni
Bellinzona,  ,  CH-6500
Switzerland
 

University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham,  Alabama,  35294-3300
United States
 

Hopital Universitaire Hautepierre
Strasbourg,  ,  67098
France
 

CHU de la Timone
Marseille,  ,  13385
France
 

Port Mcquarie Base Hospital
Port Macquarie,  New South Wales,  2444
Australia
 

Siriraj Hospital
Bangkok,  ,  10700
Thailand
 

Hopital Bellevue
Saint-Etienne,  ,  42055
France
 

AKH Vienna
Vienna (Wien),  ,  A-1090
Austria
 

Hopital de la Croix Rousse
Lyon,  ,  69317
France
 

Central Hospital
Karlstad,  ,  65185
Sweden
 

Hospital Italiano
Buenos Aires,  ,  CP118-1ACH
Argentina
 


Additional Information:
Study ID Numbers:
  CDR0000068350;  ROCHE-M66001
Study Start Date: October 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009737

Other Stage 3 Colon Cancer Studies:
1. Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer

2. Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed

3. Combination Chemotherapy in Treating Patients With Stage III Colon Cancer

4. Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer

5. Combination Chemotherapy in Treating Patients With Colorectal Cancer

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Capecitabine Compared With Fluorouracil Plus Leucovorin in Treating Patients Who Have Undergone Surgery for Stage III Colon Cancer

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