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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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