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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.
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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
Related Studies:
Other stage 3 colon cancer Clinical Trials
Other Clinical Trials
Other Riga Clinical Trials
Capecitabine Compared With Fluorouracil Plus Leucovorin in Treating Patients Who Have Undergone Surgery for Stage III Colon Cancer
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