FOLFOXIRI Compared With FOLFIRI for Metastatic Colorectal Cancer
NCT ID: NCT01219920
Last Updated: 2015-03-11
Study Results
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Basic Information
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COMPLETED
PHASE3
244 participants
INTERVENTIONAL
2001-11-30
2009-11-30
Brief Summary
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Detailed Description
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Therefore, a way to improve the outcome of metastatic colorectal cancer patients could be to administer a first-line regimen containing the three active agents.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FOLFIRI
Irinotecan 180 mg/sqm on day 1 Leucovorin 100 mg/sqm on day 1 and day 2 5-fluorouracil 400 mg/sqm bolus followed by 5-fluorouracil 600 mg/sqm 22-hour continuous infusion on day 1 and day 2 Repeated every 2 weeks
FOLFIRI
Irinotecan 180 mg/sqm on day 1 Leucovorin 100 mg/sqm on day 1 and day 2 5-fluorouracil 400 mg/sqm bolus followed by 5-fluorouracil 600 mg/sqm 22-hour continuous infusion on day 1 and day 2 Repeated every 2 weeks
FOLFOXIRI
Irinotecan 165 mg/sqm on day 1 Oxaliplatin 85 mg/sqm on day 1 Leucovorin 200 mg/sqm on day 1 5-fluorouracil 3200 mg/sqm 48-hour continuous infusion starting on day 1 Repeated every 2 weeks
FOLFOXIRI
Irinotecan 165 mg/sqm on day 1 Oxaliplatin 85 mg/sqm on day 1 Leucovorin 200 mg/sqm on day 1 5-fluorouracil 3200 mg/sqm 48-hour continuous infusion starting on day 1 Repeated every 2 weeks
Interventions
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FOLFIRI
Irinotecan 180 mg/sqm on day 1 Leucovorin 100 mg/sqm on day 1 and day 2 5-fluorouracil 400 mg/sqm bolus followed by 5-fluorouracil 600 mg/sqm 22-hour continuous infusion on day 1 and day 2 Repeated every 2 weeks
FOLFOXIRI
Irinotecan 165 mg/sqm on day 1 Oxaliplatin 85 mg/sqm on day 1 Leucovorin 200 mg/sqm on day 1 5-fluorouracil 3200 mg/sqm 48-hour continuous infusion starting on day 1 Repeated every 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* unresectable metastatic disease
* age 18 to 75 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower if age 70 years or younger or ECOG performance status of 0 if age 71 to 75 years measurable disease according to WHOcriteria
* leukocyte count of at least 3,500/mm3, neutrophils count of at least 1,500/mm3, platelet count of at least 100,000/mm3
* serum creatinine of 1.3 mg/dL or less
* serum bilirubin less than 1.5 mg/dL and AST, ALT, and alkaline phosphatase 2.5 x normal values or less (\</= 5 if liver metastases)
* previous fluoropyrimidine-based adjuvant chemotherapy was allowed if ended more than 6 months before random assignment
Exclusion Criteria
* previous chemotherapy including irinotecan or oxaliplatin
* symptomatic cardiac disease, myocardial infarction in the last 24 months or uncontrolled arrhythmia
* active infections
* inflammatory bowel disease
* total colectomy
18 Years
75 Years
ALL
No
Sponsors
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Gruppo Oncologico del Nord-Ovest
OTHER
Responsible Party
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Principal Investigators
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Alfredo Falcone, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pisa
Locations
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Ospedale Civile Ss. Antonio E Biagio Di Alessandria - Alessandria (Al) Oncologia Medica
Alessandria, , Italy
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona - Ancona (An) Oncologia Medica
Ancona, , Italy
Ausl Della Valle D' Aosta (Ao) - Aosta (Ao) Oncologia Medica
Aosta, , Italy
P.O. Zona Aretina - Ospedale S. Donato Di Arezzo - Arezzo (Ar) Oncologia Medica
Arezzo, , Italy
Azienda Ospedale 'G.Rummo' - Benevento (Bn) Oncologia Medica
Benevento, , Italy
Ospedale Degli Infermi Di Biella - Biella (Bi) Oncologia Medica
Biella, , Italy
Ospedale S. Orsola F.B.F. - Brescia - Brescia (Bs) Oncologia Medica
Brescia, , Italy
Stabilimento "Perrino" - Brindisi - Brindisi (Br) Oncologia Medica
Brindisi, , Italy
Azienda Ospedaliera S. Elia - Caltanissetta (Cl) Oncologia Medica
Caltanissetta, , Italy
Ospedale Versilia - Camaiore (Lu) Oncologia Medica
Camaiore, , Italy
Ospedale Cecina - Cecina (Li) Oncologia Medica
Cecina, , Italy
Istituti Ospitalieri - Cremona - Cremona (Cr) Oncologia Medica
Cremona, , Italy
Azienda Ospedaliera S. Croce E Carle Di Cuneo - Cuneo (Cn) Oncologia Medica
Cuneo, , Italy
Ausl 11 Di Empoli (Fi) - Empoli (Fi) Oncologia Medica
Empoli, , Italy
Asur - Zona Territoriale 6 Di Fabriano (An) - Fabriano (An) Oncologia Medica
Fabriano, , Italy
Ospedale Santa Croce Fano - Fano (Pu) Oncologia Medica
Fano, , Italy
Ausl 10 Di Firenze - Firenze (Fi) Oncologia Medica
Florence, , Italy
A.O. Universitaria Careggi Di Firenze Oncologia Medica
Florence, , Italy
E.O. Ospedali Galliera - Genova (Ge) Oncologia Medica
Genova, , Italy
Irccs Istituto Nazionale Per La Ricerca Sul Cancro (Ist) - Genova (Ge) Oncologia Medica
Genova, , Italy
Ospedale Sant'Andrea La Spezia - La Spezia (Sp) Oncologia Medica
La Spezia, , Italy
Ausl Le Di Lecce - Lecce (Le) Oncologia Chirurgica
Lecce, , Italy
Ospedale Per Acuti "Mater Salutis" Legn. - Legnago (Vr) Oncologia Medica
Legnano, , Italy
U.O. Oncologia Medica, Ospedale Civile
Livorno, , Italy
Presidio Ospedaliero Piana Di Lucca - Lucca (Lu) Oncologia Medica
Lucca, , Italy
Irccs Fondazione Centro S. Raffaele Del Monte Tabor - Milano (Mi) Oncologia Medica
Milan, , Italy
Ospedale Ca' Granda-Niguarda - Milano - Milano (Mi) Oncologia Medica
Milan, , Italy
Ospedale Civile Di Mirano - Mirano (Ve) Oncologia Medica
Mirano, , Italy
A.O. Universitaria Federico Ii Di Napoli Oncologia Medica
Napoli, , Italy
A.O. Universitaria Maggiore Della Carita' Di Novara Oncologia Medica
Novara, , Italy
A.O. Universitaria Di Parma Oncologia Medica
Parma, , Italy
Asl 1 Di Citta' Di Castello (Pg) - Citta' Di Castello (Pg) Oncologia Medica
Perugia, , Italy
A.O. Di Perugia - Ospedale S. Maria Della Misericordia (Ex Silvestrini) - Perugia (Pg) Oncologia Medica
Perugia, , Italy
Azienda Ospedaliera San Salvatore - Pesaro (Pu) Oncologia Medica
Pesaro, , Italy
Ospedale Piombino - Piombino (Li) Oncologia Medica
Piombino, , Italy
Ausl 5 Di Pisa - Pisa (Pi) Oncologia Medica
Pisa, , Italy
A.O. Universitaria Pisana - Pisa (Pi) Oncologia Medica
Pisa, , Italy
A.O. Universitaria Pisana Oncologia Medica
Pisa, , Italy
Ausl 3 Di Pistoia - Pistoia (Pt) Oncologia Medica
Pistoia, , Italy
Ospedali Riuniti Di Pistoia - Pistoia (Pt) Oncologia Medica
Pistoia, , Italy
Ospedale Di S. Maria Nuova - Reggio Nell'Emilia
Reggio Emilia, , Italy
Policlinico Universitario Campus Bio-Medico Di Roma Oncologia Medica
Roma, , Italy
Policlinico Umberto I Di Roma Oncologia Medica
Roma, , Italy
Policlinico Universitario Gemelli Di Roma Oncologia Medica
Roma, , Italy
A.O. Universitaria Senese Oncologia Medica
Siena, , Italy
Ausl 7 Di Siena - Siena (Si) Oncologia Medica
Siena, , Italy
Ospedale Civile - Sondrio - Sondrio (So) Oncologia Medica
Sondrio, , Italy
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino Oncologia Medica
Torino, , Italy
Countries
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References
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Falcone A, Ricci S, Brunetti I, Pfanner E, Allegrini G, Barbara C, Crino L, Benedetti G, Evangelista W, Fanchini L, Cortesi E, Picone V, Vitello S, Chiara S, Granetto C, Porcile G, Fioretto L, Orlandini C, Andreuccetti M, Masi G; Gruppo Oncologico Nord Ovest. Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the Gruppo Oncologico Nord Ovest. J Clin Oncol. 2007 May 1;25(13):1670-6. doi: 10.1200/JCO.2006.09.0928.
Masi G, Vasile E, Loupakis F, Bursi S, Ricci S, Petrini I, Fontana A, Allegrini G, Falcone A. Triplet combination of fluoropyrimidines, oxaliplatin, and irinotecan in the first-line treatment of metastatic colorectal cancer. Clin Colorectal Cancer. 2008 Jan;7(1):7-14. doi: 10.3816/CCC.2008.n.002.
Masi G, Loupakis F, Pollina L, Vasile E, Cupini S, Ricci S, Brunetti IM, Ferraldeschi R, Naso G, Filipponi F, Pietrabissa A, Goletti O, Baldi G, Fornaro L, Andreuccetti M, Falcone A. Long-term outcome of initially unresectable metastatic colorectal cancer patients treated with 5-fluorouracil/leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) followed by radical surgery of metastases. Ann Surg. 2009 Mar;249(3):420-5. doi: 10.1097/SLA.0b013e31819a0486.
Cremolini C, Loupakis F, Masi G, Lonardi S, Granetto C, Mancini ML, Chiara S, Moretto R, Rossini D, Vitello S, Allegrini G, Tonini G, Bergamo F, Tomasello G, Ronzoni M, Buonadonna A, Bustreo S, Barbara C, Boni L, Falcone A. FOLFOXIRI or FOLFOXIRI plus bevacizumab as first-line treatment of metastatic colorectal cancer: a propensity score-adjusted analysis from two randomized clinical trials. Ann Oncol. 2016 May;27(5):843-9. doi: 10.1093/annonc/mdw052. Epub 2016 Feb 9.
Other Identifiers
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2007-002886-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ASL601LIOM03
Identifier Type: -
Identifier Source: org_study_id
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