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Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer Clinical research trials and Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer. Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer  Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
For Condition: stage 2 rectal cancer,stage 2 colon cancer,stage 3 rectal cancer,stage 3 colon cancer
Status: No longer recruiting
Sponsor(s): European Institute of Oncology ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FrancescoTonelli, Study Chair, Universita Degli Studi di Firenze - Policlin. di Careggi
U.S.S.L. 72 Magenta
Magenta, , 20013
Italy
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), , 16132
Italy
Istituto Scientifico H.S. Raffaele
Milano, , 20132
Italy
Ospedale Civile Rho
Rho, , 20017
Italy
Ospedale San Filippo Neri
Rome, , 00135
Italy
Ospedale Luigi Sacco
Milano (Milan), , 20157
Italy
Spedali Civili
Brescia, , 25124
Italy
Ospedale Maggiore Ca Granda
Milano (Milan), , 20162
Italy
Azienda Ospedaliera S. Maria
Terni, , 05100
Italy
Ospedale Bassini
Balsamo Cinisello, , 20092
Italy
Ospedale Sesto San Giovanni
Sesto San Giovanni, , 20099
Italy
ASL NO. 1 Imperiese
San Remo, , 18038
Italy
Ospedale Umberto I
Lugo DI Romagna, , 48022
Italy
Ospedale S.S. Annunziata
Savigliano, , 12038
Italy
Ospedale Carlo Forlanini
Rome, , 00149
Italy
Ospedale Agnelli
Pinerolo, , 10064
Italy
Istituti Fisioterapici Ospitalieri - Roma
Rome, , 00128
Italy
Ospedale Santa Croce
Cuneo, , 12100
Italy
Ospedale Sant Anna
Como, , 22100
Italy
Ospedale Santa Croce
Moncalieri, , 10024
Italy
Ospedale Sta. Maria Delle Croci
Ravenna, , 48100
Italy
Ospedale San Carlo Borromeo
Milano (Milan), , 20153
Italy
Ospedale Maggiore Crema
Crema, , 26013
Italy
George Papanicolaou General Hospital
THESSALONIKI, , 57010
Greece
Universita Torino
Torino, , 10126
Italy
Ospedale Civile Cosenza
Cosenza, , 87100
Italy
Cattedra di Oncologia Medica - Universita
Cagliari, , 09124
Italy
Istituto Clinica Medica
Sassari, , 07100
Italy
U.S.L. 10 Villa Ognissanti
Firenze, , 50139
Italy
Ospedale San Martino/Cliniche Universitarie Convenzionate
Genoa (Genova), , 16132
Italy
Ospedale San Bortolo
Vicenza, , 36100
Italy
Azienda USSL No 4
Saronno, , 21047
Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, , 00168
Italy
Ospedale Maggiore Parma
Parma, , 43100
Italy
Ospedale Generale Prov. Boldrini
Thiene, , 36016
Italy
Ospedale Di Predabissi Melegnano
Melegnano, , 20077
Italy
Ospedale S. Chiara
Trento, , 38100
Italy
Universita Degli Studi di Bari Policlinico
Bari, , 70124
Italy
Inha University Hospital
Incheon, ,
Korea, Republic of
Azienda Ospedaliera di Padova
Padova (Padua), , 35128
Italy
Clinica Universita
Torino, , 10126
Italy
Azienda USSL NO 8
Merate, , 22055
Italy
Ospedale Di Conselice
Conselice, , 48017
Italy
Ospedale Di Gorgonzola
Gorgonzola, , 20064
Italy
Ospedale Legnago USSL 21
Legnago, , 37045
Italy
Istituto Di Science Biomediche San Paolo
Milano, , 20142
Italy
Ospedale Civile Umberto I
Mestre, , 30174
Italy
Carlo Poma Hospital
Mantova, , 46100
Italy
Ospedale Civico E Benefratelli
Palermo, , 90127
Italy
Universita Degli Studi di Udine
Udine, , 33100
Italy
Ospedale S. Camillo-Forlanini
Rome, , 00151
Italy
Universita di Ferrara
Ferrara, , 44100
Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, , 80131
Italy
Cattedra di Immunologia Clinica
Turin (TO), , 10128
Italy
Instituto Di Oncologia
Messina, , 98122
Italy
Federico II University Medical School
Naples (Napoli), , 80131
Italy
Consorzio Provinciale Antitubercolare
Milano, , 20124
Italy
Ospedale Torrette University Ancona
Parma, , 43100
Italy
Ospedale Civile Negrar
Negrar, , 37024
Italy
Ospedale Oncologico A. Businco
Cagliari, , 09124
Italy
Ospedale San Isidoro
Trescore Balneario, , 24069
Italy
Istituto Tumori/Fondazione Pascale
Naples (Napoli), , 80131
Italy
Nuovo Ospedale San Gerardo
Monza, , 20052
Italy
Ospedale Maggiore dell' Universita
Trieste, , 34100
Italy
Ospedale Civile Feltre
Feltre, , 32100
Italy
Azienda Ospedaliera
Reggio Emilia, , 42100
Italy
Ospedale Silvestrini
Perugia, , 06132
Italy
Ospedale Maggiore Lodi
Lodi, , I-20075
Italy
Azienda Policlinico Umberto Primo
Rome, , 00161
Italy
University of Padua
Padua, , 35128
Italy
Ospedale Galliera Oncologia
Genova (Genoa), , 16128
Italy
Policlinico di Careggi
Firenze (Florence), , 50134
Italy
Ospedale C. Ascalesi
Napoli, , 80139
Italy
Universita Degli Studi di Firenze - Policlin. di Careggi
Firenze (Florence), , 1 (50134)
Italy
Ospedale Civile Asilo Vittoria
Mortara, , 27036
Italy
Ospedale Cattinara
Trieste, ,
Italy
Policlinico Militare Celio
Rome, , 00184
Italy
Ospedale Valduce
Como, , 22100
Italy
Casa Di Cura San Ambrogio
Milano, , 20149
Italy
Ospedale San Giuseppe
Milano, , 20100
Italy
Ospedale San Michele
Cagliari, , 9100
Italy
Ospedale General Regional Ca Foncello
Treviso, , 31100
Italy
Ospedale di Circolo e Fondazione Macchi
Varese, , 21100
Italy
Dispensario Igiene Sociale
Toino, , 10100
Italy
Ospedale Vincenzo Monaldi
Napoli, , 80131
Italy
Additional Information:
Study ID Numbers: CDR0000065728; CNR-TONE-01,EU-97011
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003063
Other Stage 3 Colon Cancer Studies:
1. Gemcitabine in Treating Patients With Advanced Colorectal Cancer
2. High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer
3. Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer
4. Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer
5. ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer That Has Not Responded to Chemotherapy
Related Studies:
Other stage 3 colon cancer Clinical Trials
Other Clinical Trials
Other Milano Clinical Trials
Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
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