Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
NCT ID: NCT00003063
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1050 participants
INTERVENTIONAL
1991-11-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of treatment using levamisole with treatment using interferon alfa and combination chemotherapy consisting of fluorouracil and leucovorin in patients with stage II or stage III colorectal cancer.
Detailed Description
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* Assess the efficacy of the addition of levamisole or alfa interferon to fluorouracil and leucovorin calcium (folinic acid) as an adjuvant treatment of intraperitoneal colorectal cancer.
OUTLINE: This is a three arm study. Patients are randomized to receive either levamisole, alfa interferon, or no treatment.
* Arm I: Patients receive levamisole PO for 3 days every 2 weeks for 6 months before and after surgery. Fluorouracil IV bolus and leucovorin calcium (folinic acid) IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.
* Arm II: Patients receive alfa interferon-2a SC on 3 alternate days for a week before surgery and for 6 months after surgery. Fluorouracil IV bolus and folinic acid IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.
* Arm III: Patients undergo surgery followed by fluorouracil IV bolus and folinic acid IV over 1 hour on days 1-5 every 4 weeks for 6 cycles.
Patients are followed every 3 months for 2 years, then every 6 months.
PROJECTED ACCRUAL: 350 patients per arm will be accrued for a total of 1,050 patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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recombinant interferon alfa
fluorouracil
leucovorin calcium
levamisole hydrochloride
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed stage T3-T4 N0 or T1-T4 N1-3 colorectal cancer
* No evidence of residual disease after surgery
* Tumor located above peritoneal reflection
* No distant metastases
PATIENT CHARACTERISTICS:
Age:
* 75 and under
Performance status:
* WHO 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3500/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* SGPT less than 2 times upper limit of normal
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* No serious cardiac ischemia
Other:
* Adequate metabolic functions
* No prior neoplasm
* No prior/concurrent illness
* No insulin-dependent diabetes
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior immunotherapy for the current cancer
Chemotherapy
* No prior chemotherapy for the current cancer
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy for the current cancer
Surgery
* Not specified
75 Years
ALL
No
Sponsors
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European Institute of Oncology
OTHER
Principal Investigators
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Francesco Tonelli, MD
Role: STUDY_CHAIR
Universita Degli Studi di Florence - Policlinico di Careggi
Locations
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George Papanicolaou General Hospital
Thessaloniki, , Greece
Ospedale Bassini
Balsamo Cinisello, , Italy
Universita Degli Studi di Bari Policlinico
Bari, , Italy
Spedali Civili
Brescia, , Italy
Cattedra di Oncologia Medica - Universita
Cagliari, , Italy
Ospedale Oncologico A. Businco
Cagliari, , Italy
Ospedale San Michele
Cagliari, , Italy
Ospedale Sant Anna
Como, , Italy
Ospedale Valduce
Como, , Italy
Ospedale Di Conselice
Conselice, , Italy
Ospedale Civile Cosenza
Cosenza, , Italy
Ospedale Maggiore Crema
Crema, , Italy
Ospedale Santa Croce
Cuneo, , Italy
Ospedale Civile Feltre
Feltre, , Italy
Universita di Ferrara
Ferrara, , Italy
Universita Degli Studi di Firenze - Policlin. di Careggi
Firenze (Florence), , Italy
Policlinico di Careggi
Firenze (Florence), , Italy
U.S.L. 10 Villa Ognissanti
Florence, , Italy
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), , Italy
Ospedale San Martino/Cliniche Universitarie Convenzionate
Genoa (Genova), , Italy
Ospedale Galliera Oncologia
Genova (Genoa), , Italy
Ospedale Di Gorgonzola
Gorgonzola, , Italy
Ospedale Legnago USSL 21
Legnago, , Italy
Ospedale Maggiore Lodi
Lodi, , Italy
Ospedale Umberto I
Lugo DI Romagna, , Italy
U.S.S.L. 72 Magenta
Magenta, , Italy
Carlo Poma Hospital
Mantova, , Italy
Ospedale Di Predabissi Melegnano
Melegnano, , Italy
Azienda USSL NO 8
Merate, , Italy
Instituto Di Oncologia
Messina, , Italy
Ospedale Civile Umberto I
Mestre, , Italy
Ospedale San Giuseppe
Milan, , Italy
Consorzio Provinciale Antitubercolare
Milan, , Italy
Istituto Scientifico H.S. Raffaele
Milan, , Italy
Istituto Di Science Biomediche San Paolo
Milan, , Italy
Casa Di Cura San Ambrogio
Milan, , Italy
Ospedale San Carlo Borromeo
Milano (Milan), , Italy
Ospedale Luigi Sacco
Milano (Milan), , Italy
Ospedale Maggiore Ca Granda
Milano (Milan), , Italy
Ospedale Santa Croce
Moncalieri, , Italy
Nuovo Ospedale San Gerardo
Monza, , Italy
Ospedale Civile Asilo Vittoria
Mortara, , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, , Italy
Federico II University Medical School
Naples (Napoli), , Italy
Istituto Tumori/Fondazione Pascale
Naples (Napoli), , Italy
Ospedale Vincenzo Monaldi
Napoli, , Italy
Ospedale C. Ascalesi
Napoli, , Italy
Ospedale Civile Negrar
Negrar, , Italy
Azienda Ospedaliera di Padova
Padova (Padua), , Italy
University of Padua
Padua, , Italy
Ospedale Civico E Benefratelli
Palermo, , Italy
Ospedale Maggiore Parma
Parma, , Italy
Ospedale Torrette University Ancona
Parma, , Italy
Ospedale Silvestrini
Perugia, , Italy
Ospedale Agnelli
Pinerolo, , Italy
Ospedale Sta. Maria Delle Croci
Ravenna, , Italy
Azienda Ospedaliera
Reggio Emilia, , Italy
Ospedale Civile Rho
Rho, , Italy
Istituti Fisioterapici Ospitalieri - Roma
Rome, , Italy
Ospedale San Filippo Neri
Rome, , Italy
Ospedale Carlo Forlanini
Rome, , Italy
Ospedale S. Camillo-Forlanini
Rome, , Italy
Azienda Policlinico Umberto Primo
Rome, , Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, , Italy
Policlinico Militare Celio
Rome, , Italy
ASL NO. 1 Imperiese
Sanremo, , Italy
Azienda USSL No 4
Saronno, , Italy
Istituto Clinica Medica
Sassari, , Italy
Ospedale S.S. Annunziata
Savigliano, , Italy
Ospedale Sesto San Giovanni
Sesto San Giovanni, , Italy
Azienda Ospedaliera S. Maria
Terni, , Italy
Ospedale Generale Prov. Boldrini
Thiene, , Italy
Dispensario Igiene Sociale
Toino, , Italy
Clinica Universita
Torino, , Italy
Universita Torino
Torino, , Italy
Ospedale S. Chiara
Trento, , Italy
Ospedale San Isidoro
Trescore Balneario, , Italy
Ospedale General Regional Ca Foncello
Treviso, , Italy
Ospedale Maggiore dell' Universita
Trieste, , Italy
Ospedale Cattinara
Trieste, , Italy
Cattedra di Immunologia Clinica
Turin (TO), , Italy
Universita Degli Studi di Udine
Udine, , Italy
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Ospedale San Bortolo
Vicenza, , Italy
Inha University Hospital
Incheon, , South Korea
Countries
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Other Identifiers
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CNR-TONE-01
Identifier Type: -
Identifier Source: secondary_id
EU-97011
Identifier Type: -
Identifier Source: secondary_id
CDR0000065728
Identifier Type: -
Identifier Source: org_study_id