Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2026-01-01 @ 11:45 AM
Study NCT ID:
NCT00004150
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
1999-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Serbia and Montenegro']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2001-02', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-05', 'studyFirstSubmitDate': '1999-12-10', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage III colon cancer', 'adenocarcinoma of the colon', 'mucinous adenocarcinoma of the colon'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '17407575', 'type': 'BACKGROUND', '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.'}, {'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n* Compare the safety of these regimens in this patient population.\n\nOUTLINE: 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.\n\nPatients are randomized to one of two treatment arms.\n\n* Arm I: Patients receive leucovorin calcium IV followed by fluorouracil IV on days 1-5. Treatment repeats every 4 weeks for 6 courses.\n* Arm II: Patients receive high-dose fluorouracil IV continuously over 48 hours weekly for 8 weeks. Treatment repeats every 8 weeks for 3 courses.\n\nOR\n\n* 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.\n\nOR\n\n* 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.\n\nPatients are followed at 1 month, every 6 months for 4.5 years, and then annually thereafter until death.\n\nPROJECTED ACCRUAL: Approximately 1,600 patients (800 per treatment arm) will be accrued for this study within 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed stage III adenocarcinoma or mucinous adenocarcinoma of the colon\n* Must have had curative radical resection within 56 days prior to study\n\n * No local tumor therapy (i.e., polypectomy, local excision or limited intestinal resection)\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* WHO 0-1\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC at least 3,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin greater than 10.0 g/dL\n\nHepatic:\n\n* Bilirubin no greater than 2.0 mg/dL\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL\n\nCardiovascular:\n\n* No severe coronary heart disease\n* No New York Heart Association class III or IV heart failure\n\nOther:\n\n* No other malignancy within the past 10 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix\n* No uncontrolled infection\n* No other severe disease\n* No known allergy to leucovorin calcium\n* No known familial adenomatous polyposis, Crohn's disease, or ulcerative colitis\n* No hereditary syndrome (e.g., Gardner's syndrome, Turcot's syndrome, hereditary nonpolyposis colon cancer)\n* Not pregnant or nursing\n* Fertile patients must use effective contraception during and for 6 months after study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* No prior chemotherapy for colon cancer\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* No prior radiotherapy for colon cancer\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* No other concurrent systemic anticancer therapy"}, 'identificationModule': {'nctId': 'NCT00004150', 'briefTitle': 'High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CDR0000067383'}, 'secondaryIdInfos': [{'id': 'PETACC-2'}, {'id': 'EORTC-40963'}, {'id': 'FFCD-PETACC-2'}, {'id': 'GETTD-PETACC-2'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'fluorouracil', 'type': 'DRUG'}, {'name': 'leucovorin calcium', 'type': 'DRUG'}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Ziekenhuis Network Antwerpen Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hopital Universitaire Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'B-2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'U.Z. Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'B-4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU Liege - Domaine Universitaire du Sart Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': 'B-4800', 'city': 'Verviers', 'country': 'Belgium', 'facility': 'Centre Hospitalier Peltzer-La Tourelle', 'geoPoint': {'lat': 50.58907, 'lon': 5.86241}}, {'zip': '49033', 'city': 'Angers', 'country': 'France', 'facility': "Centre Hospitalier Regional et Universitaire d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '64100', 'city': 'Bayonne', 'country': 'France', 'facility': 'Clinique St. Etienne', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '90000', 'city': 'Belfort', 'country': 'France', 'facility': 'Centre Hospitalier General', 'geoPoint': {'lat': 47.64218, 'lon': 6.85385}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'CHR de Besancon - Hopital Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '76230', 'city': 'Bois-Guillaume', 'country': 'France', 'facility': 'Clinique du Cedre', 'geoPoint': {'lat': 49.4602, 'lon': 1.12219}}, {'zip': 'F-92104', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'CHU Ambroise Pare', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': '38300', 'city': 'Bourgoin', 'country': 'France', 'facility': 'Centre Hospitalier de Bourgoin - 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Sra. de la Candelaria', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'zip': '08227', 'city': 'Terrassa', 'country': 'Spain', 'facility': 'Hospital Consorci Sanitari De Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Instituto Valenciano De Oncologia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46014', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital General Universitario Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '01009', 'city': 'Vitoria-Gasteiz', 'country': 'Spain', 'facility': 'Hospital Txagorritxu', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario Lozano Blesa', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Claus-Henning Koehne, MD', 'affiliation': 'Klinikum Oldenburg'}, {'name': 'G. Leam', 'affiliation': 'Saint Laurentius Ziekenhuis'}, {'name': 'Laurent Bedenne, MD', 'affiliation': 'Hopital Du Bocage'}, {'name': 'Alfredo Carrato-Mena, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario de Elche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robert Roessle Klinik', 'class': 'INDIV'}, 'collaborators': [{'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, {'name': 'Federation Francophone de Cancerologie Digestive', 'class': 'OTHER'}, {'name': 'Grupo Espanol Tratamiento Tumores Digestivos', 'class': 'OTHER'}]}}}