Back to resultsHigh-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
fluorouracil
leucovorin calcium
adjuvant therapy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage III colon cancer, adenocarcinoma of the colon, mucinous adenocarcinoma of the colon
Eligibility 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
Sites / Locations
- Ziekenhuis Network Antwerpen Middelheim
- Institut Jules Bordet
- Hopital Universitaire Erasme
- Universitair Ziekenhuis Antwerpen
- U.Z. Gasthuisberg
- CHU Liege - Domaine Universitaire du Sart Tilman
- Centre Hospitalier Peltzer-La Tourelle
- Centre Hospitalier Regional et Universitaire d'Angers
- Clinique St. Etienne
- Centre Hospitalier General
- CHR de Besancon - Hopital Jean Minjoz
- Clinique du Cedre
- CHU Ambroise Pare
- Centre Hospitalier de Bourgoin - Jallieu
- Centre Hospitalier General
- CHU de Caen
- Centre Regional Francois Baclesse
- Centre Hospitalier de Chalons - en - Champagne
- Hopital Louis Pasteur
- Centre Hospitalier Universitaire de Dijon
- Centre de Lutte Contre le Cancer Georges-Francois Leclerc
- Clinique Pasteur
- Cabinet de Gastro-Enterologie
- Centre Hospital Universitaire Hop Huriez
- Hopital de la Croix Rousse
- Hopital Saint Joseph
- Centre Hospitalier de Meaux
- Clinique du Pont de Chaume
- Hopital St. Eloi
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
- Hopital de l'Archet
- CHR D'Orleans - Hopital de la Source
- Hopital Bichat - Claude Bernard
- Hopital Cochin
- Clinique Ste - Marie
- Institut Jean Godinot
- Polyclinique De Courlancy
- Centre Hospitalier General de Saint Nazaire
- Centre Hospitalier D'Agen
- Centre Paul Strauss
- CHU Rangueil
- Nouvelle Clinique Generale
- CHU de Nancy - Hopitaux de Brabois
- Centre Hospitalier General - St. Nicolas
- Centre Hospitalier Regionale de Vichy
- Institut Gustave Roussy
- Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
- Saint Laurentius Ziekenhuis
- Institute of Oncology and Radiology of Serbia
- Hospital General
- Hospital Virgen de los Lirios
- Hospital General - Alicante
- Hospital Universitari Germans Trias i Pujol
- Hospital de Barbastro
- Hospital Del Mar
- Institut d'Oncologia Corachan
- Hospital de la Santa Cruz I Sant Pau
- Hospital General Universitari Vall d'Hebron
- Consorci Hospitalari de la Creu Roia
- Hospital de L'esperit Sant
- Hospital Universitario Puerta Del Mar
- Hospital Universarito "Reina Sofia"
- Hospital Virgen de Luz
- Hospital Universitario de Elche
- Hospital General Virgen de las Nieves
- Hospital General Universitario De Guadalajara
- Residencia Sanitaria de Jaen
- Hospital General de Jerez
- Hospital Universitario Canarias
- Fundacion Jimenez Diaz - Clin. N.S.
- Hospital Universitario San Carlos
- Hospital Regional Carlos Haya De Malaga
- Hospital De Merida
- Hospital De Navarra
- Consorci Hospitalari del Parc Tauli
- Hospital de Sagunto
- Hospital Virgen de la Vega
- Hospital Universitari Sant Joan d'Alacant
- Hospital - Residencia Sant Camil
- Hospital Ntra. Sra. de la Candelaria
- Hospital Consorci Sanitari De Terrassa
- Instituto Valenciano De Oncologia
- Hospital General Universitario Valencia
- Hospital Txagorritxu
- Hospital Clinico Universitario Lozano Blesa
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004150
First Posted
December 10, 1999
Last Updated
November 5, 2013
Sponsor
Robert Roessle Klinik
Collaborators
European Organisation for Research and Treatment of Cancer - EORTC, Federation Francophone de Cancerologie Digestive, Grupo Espanol Tratamiento Tumores Digestivos
1. Study Identification
Unique Protocol Identification Number
NCT00004150
Brief Title
High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer
Official Title
Pan-European Trials in Adjuvant Colon Cancer (PETACC-2): Randomized Phase III Intergroup Trial of High-Dose Infusional 5-FU (+ or - Folinic Acid) Versus Standard Bolus 5-FU/Folinic Acid
Study Type
Interventional
2. Study Status
Record Verification Date
February 2001
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Robert Roessle Klinik
Collaborators
European Organisation for Research and Treatment of Cancer - EORTC, Federation Francophone de Cancerologie Digestive, Grupo Espanol Tratamiento Tumores Digestivos
4. Oversight
5. Study Description
Brief Summary
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: This randomized phase III trial is studying high-dose fluorouracil with or without leucovorin to see how well it works compared to standard-dose fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer.
Detailed Description
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.
Arm II: 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage III colon cancer, adenocarcinoma of the colon, mucinous adenocarcinoma of the colon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus-Henning Koehne, MD
Organizational Affiliation
Klinikum Oldenburg
First Name & Middle Initial & Last Name & Degree
G. Leam
Organizational Affiliation
Saint Laurentius Ziekenhuis
First Name & Middle Initial & Last Name & Degree
Laurent Bedenne, MD
Organizational Affiliation
Hopital Du Bocage
First Name & Middle Initial & Last Name & Degree
Alfredo Carrato-Mena, MD
Organizational Affiliation
Hospital Universitario de Elche
Official's Role
Study Chair
Facility Information:
Facility Name
Ziekenhuis Network Antwerpen Middelheim
City
Antwerpen
ZIP/Postal Code
B-2020
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Hopital Universitaire Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
CHU Liege - Domaine Universitaire du Sart Tilman
City
Liege
ZIP/Postal Code
B-4000
Country
Belgium
Facility Name
Centre Hospitalier Peltzer-La Tourelle
City
Verviers
ZIP/Postal Code
B-4800
Country
Belgium
Facility Name
Centre Hospitalier Regional et Universitaire d'Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Clinique St. Etienne
City
Bayonne
ZIP/Postal Code
64100
Country
France
Facility Name
Centre Hospitalier General
City
Belfort
ZIP/Postal Code
90000
Country
France
Facility Name
CHR de Besancon - Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Clinique du Cedre
City
Bois-Guillaume
ZIP/Postal Code
76230
Country
France
Facility Name
CHU Ambroise Pare
City
Boulogne Billancourt
ZIP/Postal Code
F-92104
Country
France
Facility Name
Centre Hospitalier de Bourgoin - Jallieu
City
Bourgoin-Jallieu
ZIP/Postal Code
38300
Country
France
Facility Name
Centre Hospitalier General
City
Brive
ZIP/Postal Code
19101
Country
France
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Hospitalier de Chalons - en - Champagne
City
Chalons-en-Champagne
ZIP/Postal Code
51000
Country
France
Facility Name
Hopital Louis Pasteur
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Centre Hospitalier Universitaire de Dijon
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Clinique Pasteur
City
Evreux
ZIP/Postal Code
27000
Country
France
Facility Name
Cabinet de Gastro-Enterologie
City
Les Sables d'Olonne
ZIP/Postal Code
85100
Country
France
Facility Name
Centre Hospital Universitaire Hop Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
Hopital Saint Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Centre Hospitalier de Meaux
City
Meaux
ZIP/Postal Code
77104
Country
France
Facility Name
Clinique du Pont de Chaume
City
Montauban
ZIP/Postal Code
82017
Country
France
Facility Name
Hopital St. Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Hopital de l'Archet
City
Nice
ZIP/Postal Code
F-06202
Country
France
Facility Name
CHR D'Orleans - Hopital de la Source
City
Orleans
ZIP/Postal Code
45100
Country
France
Facility Name
Hopital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Clinique Ste - Marie
City
Pontoise
ZIP/Postal Code
95301
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
Polyclinique De Courlancy
City
Reims
ZIP/Postal Code
F-51100
Country
France
Facility Name
Centre Hospitalier General de Saint Nazaire
City
Saint Nazaire
ZIP/Postal Code
44600
Country
France
Facility Name
Centre Hospitalier D'Agen
City
St. Esprit
ZIP/Postal Code
47000
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
CHU Rangueil
City
Toulouse
ZIP/Postal Code
31403
Country
France
Facility Name
Nouvelle Clinique Generale
City
Valence
ZIP/Postal Code
26000
Country
France
Facility Name
CHU de Nancy - Hopitaux de Brabois
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Centre Hospitalier General - St. Nicolas
City
Verdun
ZIP/Postal Code
55107
Country
France
Facility Name
Centre Hospitalier Regionale de Vichy
City
Vichy
ZIP/Postal Code
03201
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
City
Berlin
ZIP/Postal Code
D-13122
Country
Germany
Facility Name
Saint Laurentius Ziekenhuis
City
Roermond
ZIP/Postal Code
6043 CV
Country
Netherlands
Facility Name
Institute of Oncology and Radiology of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Hospital General
City
Albacete
ZIP/Postal Code
2006
Country
Spain
Facility Name
Hospital Virgen de los Lirios
City
Alcoi Alicante
ZIP/Postal Code
03800
Country
Spain
Facility Name
Hospital General - Alicante
City
Alicante
ZIP/Postal Code
3010
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital de Barbastro
City
Barbastro
ZIP/Postal Code
22300
Country
Spain
Facility Name
Hospital Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Institut d'Oncologia Corachan
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
Facility Name
Hospital de la Santa Cruz I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital General Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Consorci Hospitalari de la Creu Roia
City
Barcelona
ZIP/Postal Code
08906
Country
Spain
Facility Name
Hospital de L'esperit Sant
City
Barcelona
ZIP/Postal Code
08923
Country
Spain
Facility Name
Hospital Universitario Puerta Del Mar
City
Cadiz
ZIP/Postal Code
11000
Country
Spain
Facility Name
Hospital Universarito "Reina Sofia"
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Virgen de Luz
City
Cuenca
ZIP/Postal Code
16002
Country
Spain
Facility Name
Hospital Universitario de Elche
City
Elche Alicante
ZIP/Postal Code
E-03203
Country
Spain
Facility Name
Hospital General Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital General Universitario De Guadalajara
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
Facility Name
Residencia Sanitaria de Jaen
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital General de Jerez
City
Jerez
ZIP/Postal Code
11407
Country
Spain
Facility Name
Hospital Universitario Canarias
City
La Laguna
ZIP/Postal Code
38320
Country
Spain
Facility Name
Fundacion Jimenez Diaz - Clin. N.S.
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Regional Carlos Haya De Malaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital De Merida
City
Merida
ZIP/Postal Code
06800
Country
Spain
Facility Name
Hospital De Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Consorci Hospitalari del Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital de Sagunto
City
Sagunto
ZIP/Postal Code
46520
Country
Spain
Facility Name
Hospital Virgen de la Vega
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitari Sant Joan d'Alacant
City
San Juan
ZIP/Postal Code
3550
Country
Spain
Facility Name
Hospital - Residencia Sant Camil
City
Sant Pere de Ribes
ZIP/Postal Code
08810
Country
Spain
Facility Name
Hospital Ntra. Sra. de la Candelaria
City
Santa Cruz de Tenerife
ZIP/Postal Code
38003
Country
Spain
Facility Name
Hospital Consorci Sanitari De Terrassa
City
Terrassa
ZIP/Postal Code
08227
Country
Spain
Facility Name
Instituto Valenciano De Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital General Universitario Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Txagorritxu
City
Vitoria
ZIP/Postal Code
01009
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
17407575
Citation
Fensterer H, Radlwimmer B, Strater J, Buchholz M, Aust DE, Julie C, Radvanyi F, Nordlinger B, Belluco C, Van Cutsem E, Kohne CH, Kestler HA, Schwaenen C, Nessling M, Lutz MP, Lichter P, Gress TM; EORTC Gastrointestinal (GI) Group. Matrix-comparative genomic hybridization from multicenter formalin-fixed paraffin-embedded colorectal cancer tissue blocks. BMC Cancer. 2007 Apr 2;7:58. doi: 10.1186/1471-2407-7-58.
Results Reference
background
Citation
Carrato A, Köhne C, Bedenne L, et al.: Folinic acid modulated bolus 5-FU or infusional 5-FU for adjuvant treatment of patients of UICC stage III colon cancer: preliminary analysis of the PETACC-2-study. [Abstract] J Clin Oncol 24 (Suppl 18): A-3563, 2006.
Results Reference
result
Learn more about this trial
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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