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High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer Clinical research trials and High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer. High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "H" Clinical Trials Conditions > High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer  High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer
High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer
For Condition: stage 3 colon cancer,mucinous adenocarcinoma of the colon,adenocarcinoma of the colon
Status: Recruiting
Sponsor(s): Robert Roessle Klinik , EORTC Gastrointestinal Tract Cancer Cooperative Group,Federation Francophone de Cancerologie Digestive,Grupo Espanol Tratamiento Tumores Digestivos
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 chemotherapy regimen is more effective for colon cancer. PURPOSE: Randomizedphase III trial to study the effectiveness of high-dose fluorouracil with or without leucovorin compared with standard-dose fluorouracil plus leucovorin following surgery in treating patients who have stage III colon cancer.
Details: OBJECTIVES: - Compare recurrence-free survival and duration of survival in patients with stage III adenocarcinoma of the colon treated with adjuvant high-dose fluorouracil with or without leucovorin calcium versus standard fluorouracil with leucovorin calcium following curative radical resection. - Compare the safety of these regimens in this patient population. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to regional lymph node involvement (N1 (1-3 pericolic lymph nodes) vs N2 (more than 3 pericolic lymph nodes) and participating center. Patients are randomized to one of two treatment arms. - Arm I: Patients receive leucovorin calcium IV followed by fluorouracil IV on days 1-5. Treatment repeats every 4 weeks for 6 courses. - Patients receive high-dose fluorouracil IV continuously over 48 hours weekly for 8 weeks. Treatment repeats every 8 weeks for 3 courses. OR - Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 24 hours weekly for 6 weeks. Treatment repeats every 7 weeks for 3 courses. OR - Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV bolus and then fluorouracil IV continuously over 22 hours on days 1 and 2. Treatment repeats every 2 weeks for 12 courses. Patients are followed at 1 month, every 6 months for 4.5 years, and then annually thereafter until death. PROJECTED ACCRUAL: Approximately 1,600 patients (800 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage III adenocarcinoma or mucinous adenocarcinoma of the colon - Must have had curative radical resection within 56 days prior to study - No local tumor therapy (i.e., polypectomy, local excision or limited intestinal resection) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - WHO 0-1 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin greater than 10.0 g/dL Hepatic: - Bilirubin no greater than 2.0 mg/dL Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No severe coronary heart disease - No New York Heart Association class III or IV heart failure Other: - No other malignancy within the past 10 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix - No uncontrolled infection - No other severe disease - No known allergy to leucovorin calcium - No known familial adenomatous polyposis, Crohn's disease, or ulcerative colitis - No hereditary syndrome (e.g., Gardner's syndrome, Turcot's syndrome, hereditary nonpolyposis colon cancer) - Not pregnant or nursing - Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for colon cancer Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy for colon cancer Surgery: - See Disease Characteristics Other: - No other concurrent systemic anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Claus-HenningKoehne, , Robert Roessle Klinik
Residencia Sanitaria de Jaen *Recruiting*
Jaen, , 23007
Spain
Recruiting Pedro Rovira 34-953-222-408
Centre Hospitalier Regionale de Vichy *Recruiting*
Vichy, , 03201
France
Recruiting Philippe Cassan 470-973-312
Hospital Universitario Canarias *Recruiting*
La Laguna (Tenerife), , 38320
Spain
Recruiting Marta Llanos-Munoz 349-226-780-000
Hospital General Virgen de las Nieves *Recruiting*
Granada, , 18014
Spain
Recruiting Joaquin Belon 34-958-200-73
Hospital de la Santa Cruz I Sant Pau *Recruiting*
Barcelona, , 08025
Spain
Recruiting Eugenio Marcuello 349-334-731-33
Hopital Bichat - Claude Bernard *Recruiting*
Paris, , 75018
France
Recruiting Thomas Aparicio 33-01-4025-7000
Consorci Hospitalari del Parc Tauli *Recruiting*
Sabadell, , 08208
Spain
Recruiting Carlos Puaume 34-934-296-07
Hospital De Merida *Recruiting*
Merida, , 06800
Spain
Recruiting Fuensanta Bellido 34-967-597-100
CHR de Besancon - Hopital Jean Minjoz *Recruiting*
Besancon, , 25030
France
Recruiting Yacine Merrouche 477-127-654
Institut Gustave Roussy *Recruiting*
Villejuif, , F-94805
France
Recruiting Michel Ducreux 33-1-4211-4308
CHU Liege - Domaine Universitaire du Sart Tilman *Recruiting*
LIEGE, , B-4000
Belgium
Recruiting Marc Polus 324-366-7664
Hopital Saint Joseph *Recruiting*
Marseille, , 13008
France
Recruiting Herve Perrier 491-806-608
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle *Recruiting*
Montpellier, , 34298
France
Recruiting Marc Ychou 33-04-67-613-066
Fundacion Jimenez Diaz - Clin. N.S. *Recruiting*
Madrid, , 28040
Spain
Recruiting Ana Leon 349-155-04800
Clinique Generale *Recruiting*
Valence, , 26000
France
Recruiting Remy Mackiewicz 475-782-466
Centre Hospitalier General *Recruiting*
Belfort, , 90000
France
Recruiting Serge Fratte 384-574-095
Hospital General *Recruiting*
Albacete, , 2006
Spain
Recruiting Carmen Alonso 34-967-597-100
Hopital Louis Pasteur *Recruiting*
Colmar, , 68024
France
Recruiting Bernard Denis 33-3-8912-4000
Hospital Clinico Universitario *Recruiting*
Zaragoza, , 50009
Spain
Recruiting Pilar Escudero 349-763-50418
Hopital de l'Archet *Recruiting*
Nice, , F-06202
France
Recruiting Francois Caroli-Bosc 33-4-9203-6021
Hopital Universitaire Erasme *Recruiting*
Brussels, , 1070
Belgium
Recruiting Jean Luc Van Laethem 32-2-555-3712
Hospital Universitario San Carlos *Recruiting*
Madrid, , 28040
Spain
Recruiting Eduardo Diaz-Rubio 34-91-330-3546
Hospital Regional Carlos Haya De Malaga *Recruiting*
Malaga, , 29010
Spain
Recruiting Juan Breton 34-95-227-7400
Hopital de la Croix Rousse *Recruiting*
Lyon, , 69317
France
Recruiting Jacques Beaulieux 472-071-625
Centre Hospitalier General de Saint Nazaire *Recruiting*
Saint-Nazaire, , 44600
France
Recruiting Philippe Deguiral 240-538-844
Centre Hospitalier Universitaire de Dijon *Recruiting*
Dijon, , 21034
France
Recruiting Laurent Bedenne 33-380-293-750
Institute of Oncology and Radiology of Serbia *Recruiting*
Belgrade, , 11000
Yugoslavia
Recruiting Ivan Popov 381-11-361-4660
Centre Hospitalier de Bourgoin - Jallieu *Recruiting*
Bourgoin-Jallieu, , 38300
France
Recruiting Noel Stremsdoerfer 474-273-011
Centre Hospitalier de Meaux *Recruiting*
Meaux, , 77104
France
Recruiting Michel Glikmanas 33-1-6435-3853
Saint Laurentius Ziekenhuis *Recruiting*
Roermond, , 6043 CV
Netherlands
Recruiting G. Leam 31-475-382-866
Centre Hospitalier General - St. Nicolas *Recruiting*
Verdun, , 55107
France
Recruiting Jean-Francois Roche 33-3-2983-8485
Instituto Valenciano De Oncologia *Recruiting*
Valencia, , 46009
Spain
Recruiting Carlos Martos 34-96-349-3411
CHU Ambroise Pare *Recruiting*
Boulogne-Billancourt, , F-92104
France
Recruiting Philippe Rougier 33-01-49-095-325
CHU de Caen *Recruiting*
Caen, , 14033
France
Recruiting Dominique Arsene 33-2-3106-4514
Hospital Txagorritxu *Recruiting*
Vitoria, , 01009
Spain
Recruiting Severina Dominguez 349-450-070-00
Algemeen Ziekenhuis Middelheim *Recruiting*
Antwerpen, , B-2020
Belgium
Recruiting Eric Joosens 32-3-280-4030
Centre Hospital Universitaire Hop Huriez *Recruiting*
Lille, , 59037
France
Recruiting Mohamed Hebbar 33-3-2044-5479
Hospital General Universitario Valencia *Recruiting*
Valencia, , 46014
Spain
Recruiting J.M. Vicent 34-963-862-900
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Eric Cutsem 32-16-34-42-25
Clinique St. Etienne *Recruiting*
Bayonne, , 64100
France
Recruiting Emmanuel Echinard 055-955-7500
Hospital de Barbastro *Recruiting*
Barbastro, , 22300
Spain
Recruiting Pilar Bueso 34-974-313-511
Polyclinique De Courlancy *Recruiting*
Reims, , F-51100
France
Recruiting Bruno Garcia 333-2677-2060
CHU Rangueil *Recruiting*
Toulouse, , 31403
France
Recruiting Jacques Moreau 33-4-6132-2762
Hospital Consorci Sanitari De Terrassa *Recruiting*
Terrassa, , 08227
Spain
Recruiting Jordi Alfaro 34-937-3600
Hopital St. Eloi *Recruiting*
Montpellier, , 34295
France
Recruiting Jean Fabre 33-4-6733-7072
Hospital Virgen de Luz *Recruiting*
Cuenca, , 16002
Spain
Recruiting Maria Sanchez 34-969-179-900
CHU de Nancy - Hopitaux de Brabois *Recruiting*
Vandoeuvre-les-Nancy, , 54511
France
Recruiting Thierry Conroy 333-8315-3119
Hospital General Universitari Vall d'Hebron *Recruiting*
Barcelona, , 08035
Spain
Recruiting Lucia Santome 349-3274-6000
Clinique Pasteur *Recruiting*
Evreux, , 27000
France
Recruiting Nicolas Albin 33-232-33-0356
Hospital Universitari Germans Trias i Pujol *Recruiting*
Barcelona, , 08916
Spain
Recruiting Albert Abad-Esteve 349-346-51200
Clinique du Pont de Chaume *Recruiting*
Montauban, , 82017
France
Recruiting Patrice Pienkowski 563-683-490
Centre Hospitalier General *Recruiting*
Brive, , 19101
France
Recruiting Bernard Leduc 0555-92-60-00
Centre Hospitalier D'Agen *Recruiting*
St. Esprit, , 47000
France
Recruiting Bertrand Tissot 553-697-071
Institut Jean Godinot *Recruiting*
Reims, , 51056
France
Recruiting Salvador Nasca 03-26-50-4444
Hospital Ntra. Sra. de la Candelaria *Recruiting*
Santa Cruz de Tenerife, , 38003
Spain
Recruiting Javier Dorta 34-922-600-070
Hospital Virgen de los Lirios *Recruiting*
Alcoi Alicante, , 03800
Spain
Recruiting Inmaculada Maestu 34-96-652-8804
Consorci Hospitalari de la Creu Roia *Recruiting*
Barcelona, , 08906
Spain
Recruiting Ferran Gaspa 34-932-407-500
Hospital Universitari Sant Joan d'Alacant *Recruiting*
San Juan (Alicante), , 3550
Spain
Recruiting Jose Lizon 34-96-593-8639
Hospital Del Mar *Recruiting*
Barcelona, , 08003
Spain
Recruiting Manuel Gallen 34-93-248-3137
Hospital Universitario Puerta Del Mar *Recruiting*
Cadiz, , 11000
Spain
Recruiting Maria Gomez Raina 349-6242-100
Hopital Cochin *Recruiting*
Paris, , 75674
France
Recruiting Catherine Brezault-Bonnet 158-411-963
Institut Jules Bordet *Recruiting*
Brussels, , 1000
Belgium
Recruiting Harry Bleiberg 33-241-35-3618
Hospital Virgen de la Vega *Recruiting*
Salamanca, , 37007
Spain
Recruiting Juan Cruz Hernandez 34-923-291-200
Hospital - Residencia Sant Camil *Recruiting*
Sant Pere de Ribes, , 08810
Spain
Recruiting Montserrat Bolleda 34-938-960-025
Hospital General Universitario De Guadalajara *Recruiting*
Guadalajara, , 19002
Spain
Recruiting Javier Casinello 34-949-209-200
Universitair Ziekenhuis Antwerpen *Recruiting*
Edegem, , B-2650
Belgium
Recruiting Jan Vermorken 32-3-821-3954
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc *Recruiting*
Dijon, , 21079
France
Recruiting Bruno Coudert 33-03-80-737-528
Robert Roessle Klinik *Recruiting*
Berlin, , D-13122
Germany
Recruiting Claus-Henning Koehne 49-30-9417-1298
Centre Regional Francois Baclesse *Recruiting*
Caen, , 14076
France
Recruiting Jacques Jacob 231-455-016
Clinique Ste - Marie *Recruiting*
Pontoise, , 95301
France
Recruiting Jerome Lacourt 385-476-182
Hospital Universarito "Reina Sofia" *Recruiting*
Cordoba, , 14004
Spain
Recruiting Enrique Aguilar 34-957-011-626
Centre Hospitalier Regional et Universitaire d'Angers *Recruiting*
Angers, , 49033
France
Recruiting Jean-Pierre Arnaud 33-02-41-354-958
Centre Hospitalier de Chalons - en - Champagne *Recruiting*
Chalons-en-Champagne, , 51000
France
Recruiting Brixi Benmansour 33-326-696-051
Centre Paul Strauss *Recruiting*
Strasbourg, , 67065
France
Recruiting Christian Borel 33-3-8825-2585
Hospital General - Alicante *Recruiting*
Alicante, , 3010
Spain
Recruiting Bartomeu Massuti 34-96-593-8448
Hospital General de Jerez *Recruiting*
Jerez, , 11407
Spain
Recruiting Encarnacion Orozco 349-560-35000
Centre Hospitalier Peltzer-La Tourelle *Recruiting*
Verviers, , B-4800
Belgium
Recruiting Hassan Kalantari 328-721-2128
Institut d'Oncologia Corachan *Recruiting*
Barcelona, , 08017
Spain
Recruiting Teresa Checa 34-932-800-022
CHR D'Orleans - Hopital de la Source *Recruiting*
Orleans, , 45100
France
Recruiting Jean-Paul Lagasse 33-02-3651-4704
Cabinet de Gastro-Enterologie *Recruiting*
Les Sables-d'Olonne, , 85100
France
Recruiting Jean Danielou 251-327-296
Hospital De Navarra *Recruiting*
Pamplona, , 31008
Spain
Recruiting Ruth Vera 349-434-470-00
Hospital Universitario de Elche *Recruiting*
Elche Alicante, , E-03203
Spain
Recruiting Alfredo Carrato-Mena 34-96-667-9359
Hospital de L'esperit Sant *Recruiting*
Barcelona, , 08923
Spain
Recruiting Cristina Lorente 34-933-869-648
Clinique du Cedre *Recruiting*
Bois-Guillaume, , 76230
France
Recruiting Chistian Paoletti 235-595-988
Hospital de Sagunto *Recruiting*
Sagunto, , 46520
Spain
Recruiting Antonio Galan 349-626-594-05
Additional Information:
Study ID Numbers: CDR0000067383; PETACC-2,EORTC-40963,FFCD-PETACC-2,GETTD-PETACC-2
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004150
Other Adenocarcinoma Of The Colon Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
2. Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
3. Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer
4. SU5416 in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
5. Genetic Study of Familial Factors in Patients With Colon Cancer
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High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer
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