Spots Global Cancer Trial Database for Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
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Trial Identification
Brief Title: Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
Official Title: Adjuvant Chemoimmunotherapy for Colorectal Cancer
Study ID: NCT00003063
Conditions
Study Description
Brief Summary: RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells. 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: OBJECTIVES: * 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Firenze, , 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 Carlo Borromeo, Milano (Milan), , Italy
Ospedale Luigi Sacco, Milano (Milan), , Italy
Ospedale Maggiore Ca Granda, Milano (Milan), , Italy
Ospedale San Giuseppe, Milano, , Italy
Consorzio Provinciale Antitubercolare, Milano, , Italy
Istituto Scientifico H.S. Raffaele, Milano, , Italy
Istituto Di Science Biomediche San Paolo, Milano, , Italy
Casa Di Cura San Ambrogio, Milano, , Italy
Ospedale Santa Croce, Moncalieri, , Italy
Nuovo Ospedale San Gerardo, Monza, , Italy
Ospedale Civile Asilo Vittoria, Mortara, , Italy
Federico II University Medical School, Naples (Napoli), , Italy
Istituto Tumori/Fondazione Pascale, Naples (Napoli), , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori, Naples, , 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, San Remo, , 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, , Korea, Republic of
Contact Details
Name: Francesco Tonelli, MD
Affiliation: Universita Degli Studi di Florence - Policlinico di Careggi
Role: STUDY_CHAIR
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