FOLFOX-4 3months Versus 6 Months and Bevacizumab as Adjuvant Therapy for Patients With Stage II/III Colon Cancer
NCT ID: NCT00646607
Last Updated: 2014-11-26
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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COMPLETED
PHASE3
3756 participants
INTERVENTIONAL
2007-06-30
2014-11-30
Brief Summary
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As both are open label studies, there will be no blinding of treatment assignment.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
FOLFOX-4 (infusional 5-Fluouracil, leucovorin and oxaliplatin) for 3 months or XELOX (capecitabine and oxaliplatin) for 12 weeks.
FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)
To assess whether a 3-month FOLFOX-4 treatment is at least equivalent to a 6-month FOLFOX-4 treatment
B
FOLFOX-4 (infusional 5-Fluouracil, leucovorin and oxaliplatin) for 6 months or XELOX (capecitabine and oxaliplatin) for 24 weeks.
FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)
standard treatment
Interventions
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FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)
To assess whether a 3-month FOLFOX-4 treatment is at least equivalent to a 6-month FOLFOX-4 treatment
FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)
standard treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage II patients have to be considered at high-risk if they fulfill \>1 of the following criteria:
* T4 tumours,
* grade \>3,
* clinical presentation with bowel obstruction or perforation,
* histological signs of vascular or lymphatic or perineural invasion,
* \<12 nodes examined
* Age 18 to 75 years
* Curative surgery no less than 3 ( 4 in the BEV study) and no more than 8 weeks prior to randomization
* ECOG performance Status (ECOG-PS) \<1
* Signed written informed consent obtained prior to any study specific procedures
Exclusion Criteria
* Previous anti-angiogenic treatment for any malignancy; cytotoxic chemotherapy, radiotherapy or immunotherapy for colon cancer
* Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)
* Lactating women
* Fertile women (\<2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception
* History of clinically relevant psychiatric disability , precluding informed consent
* Clinically relevant cardiovascular disease
* History or presence of other diseases
* Evidence of bleeding diathesis or coagulopathy
* Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes
* Chronic, daily treatment with high-dose aspirin (\>325 mg/day) or clopidogrel (\>75 mg/day)
* Current or recent (within the 28 days prior to randomization) treatment with another investigational drug or participation in another investigational study
18 Years
75 Years
ALL
No
Sponsors
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Mario Negri Institute for Pharmacological Research
OTHER
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
OTHER
Responsible Party
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Principal Investigators
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Roberto Labianca, MD
Role: PRINCIPAL_INVESTIGATOR
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Alberto Sobrero, MD
Role: STUDY_CHAIR
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Locations
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Ospedale Santo Spirito
Casale Monferrato, AL, Italy
A.O. Umberto I -Università Località Torrette
Ancona, AN, Italy
Ospedale Profili
Fabriano, AN, Italy
Ospedale Mazzoni
Ascoli Piceno, AP, Italy
Usl 11 Ospedale Murri
Fermo, AP, Italy
Università di L'Aquila
L’Aquila, AQ, Italy
ASL 8 di Arezzo
Arezzo, AR, Italy
P.O. Ospedale S.M. Della Gruccia
Montevarchi, AR, Italy
Ospedale Civile
Asti, AT, Italy
Ospedale di Altamura
Altamura, BA, Italy
Ospedali Riuniti, Largo Barozzi, 1
Bergamo, Bergamo, Italy
A.O. Treviglio-Caravaggio, P.le Ospedale n1
Treviglio, Bergamo, Italy
Ospedale degli Infermi
Biella, BI, Italy
A.O. G.Rummo
Benevento, BN, Italy
Fondazione Poliambulanza
Brescia, BS, Italy
Ospedale S.Orsola Fatebenefratelli
Brescia, BS, Italy
Spedali Civili
Brescia, BS, Italy
Azienda M.Mellini-Chiara
Iseo, BS, Italy
Ospedale di Manerbio
Manerbio, Bs, Italy
Ospedale Regionale
Bolzano, BZ, Italy
Ospedale S.Barbara - Asl 7
Iglesias, CA, Italy
Policlinico Universitario
Monserrato, CA, Italy
A.O. S.Sebastiano
Caserta, CE, Italy
AUSL di Lanciano-Vasto
Lanciano, CH, Italy
Ospedale S.Lazzaro
Alba, CN, Italy
A.O. S.Croce e Carle
Cuneo, CN, Italy
Ospedale S.Anna
Como, CO, Italy
ospedale Valduce
Como, CO, Italy
Ospedale Fatebenefratelli Sacra Famiglia
Erba, CO, Italy
Azienda Istituti Ospitalieri
Cremona, CR, Italy
Azienda Ospedaliera
Catania, CT, Italy
ASL 6 - Ospedale Civile
Lamezia Terme, CZ, Italy
A.O. Careggi-Università, Viale Pieraccini, 17
Florence, Firenze, Italy
ASL 11
Empoli, FI, Italy
Ospedale S.M.Annunziata-ASL FI
Florence, FI, Italy
A.O. Ospedale Careggi - Università
Florence, FI, Italy
Ospedale M.Bufalini
Cesena, FO, Italy
A.O. Morgagni-Pierantoni
Forlì, FO, Italy
A.O. Ospedale S.Martino
Genova, GE, Italy
Istituto Nazionale ricerca Cancro
Genova, GE, Italy
Università-Ospedale san Martino
Genova, GE, Italy
Azienda Ospedaliera di Lecco
Lecco, LC, Italy
Azienda Usl-6 Università
Livorno, LI, Italy
Ospedale di Casalpusterlengo
Casalpusterlengo, LO, Italy
Centro Oncologico Conti
Gaeta, Lt, Italy
Azienda USL LT3
Latina, LT, Italy
Ospedale Unico Versilia
Lido di Camaiore, LU, Italy
A.O. Università-Policlinico
Messina, ME, Italy
Ospedale Serbelloni
Gorgonzola, MI, Italy
Azienda Ospedaliera
Legnano, MI, Italy
Azienda Ospedale Civile
Magenta, MI, Italy
A.O. Ospedale Fatebenefratelli
Milan, MI, Italy
A.O. san Paolo
Milan, MI, Italy
Casa di Cura Igea
Milan, MI, Italy
Istituto dei Tumori
Milan, MI, Italy
Istituto di Ricerca S.Raffaele
Milan, MI, Italy
Istituto Europeo di Oncologia
Milan, MI, Italy
Ospedale Luigi Sacco
Milan, MI, Italy
Ospedale S.Carlo Borromeo
Milan, MI, Italy
A.O. s.Gerardo
Monza, MI, Italy
Istituto Clinico Humanitas
Rozzano, MI, Italy
Multimedica
Sesto San Giovanni, MI, Italy
A.O. Ospedale carlo Poma
Mantova, MN, Italy
Ospedale ramazzini
Carpi, MO, Italy
USL 1 di Massa e Carrara
Carrara, MS, Italy
Ospedale Oncologico M.Ascoli
Palermo, PA, Italy
Policlinico Giaccone
Palermo, PA, Italy
Azienda Ospedale Civile
Piacenza, PC, Italy
Istituto Oncologico Veneto
Padua, PD, Italy
Ospedale Santo Spirito
Penne, PE, Italy
Ospedale Santo Spirito
Pescara, PE, Italy
ASL 1
Città di Castello, PG, Italy
Centro Riferimento
Aviano, PN, Italy
A.O. S.Maria degli Angeli
Pordenone, PN, Italy
Ospedale ASL 4
Prato, PO, Italy
Azienda Ospedaliera
Parma, PR, Italy
Ospedale Santa Croce
Fano, PS, Italy
A.O. S.Salvatore
Pesaro, PS, Italy
Azienda Ospedaliera San Carlo
Potenza, PZ, Italy
Centro Riferimento Oncologico Basilicata
Rionero in Volture, PZ, Italy
Ospedale per gli Infermi
Faenza, RA, Italy
Ospedale Umberto I
Lugo, RA, Italy
A.O. Santa Maria delle Croci
Ravenna, RA, Italy
Azienda Ospedali Riuniti
Reggio Calabria, RC, Italy
A.O. Santa maria Nuova-Spallanzani
Reggio Emilia, RE, Italy
Ospedale S.Camillo
Roma, RM, Italy
Policlinico Militare Celio
Roma, RM, Italy
Università Policlinico Umberto I
Roma, RM, Italy
Ospedale Sant'Andrea
Roma, RM, Italy
Azienda ospedaliera
Cattolica, RN, Italy
Ospedale degli Infermi
Rimini, RN, Italy
Università Campus Biomedico, Via Emilio Longoni, 83
Roma, Roma, Italy
A.O. S.Giovanni Calabita Fatebenefratelli
Roma, Roma, Italy
AULSS 18 di Rovigo
Rovigo, RO, Italy
Ospedale Morelli
Sondalo, SO, Italy
A.O. Valtellina e Chiavenna
Sondrio, SO, Italy
A.O. Santa Corona
Pietra Ligure, SV, Italy
Università degli Studi
Candiolo, TO, Italy
Ospedale S.Giovanni Bosco
Torino, TO, Italy
Ospedale Civile
Latisana, UD, Italy
Casa di Cura Santa Maria
Castellanza, VA, Italy
Ulss 5 Ovest Vicentino
Montecchio Maggiore, VI, Italy
Ospedale Negrar
Negrar, VR, Italy
Ospedale S.Leonardo
Castellamare Di Stabbia, , Italy
Fondazione Pascale - Istituto Tumori
Napoli, , Italy
Istituto Tumori- Pascale
Napoli, , Italy
Università federico II
Napoli, , Italy
A.O. Cardarelli
Napoli, , Italy
Azienda Ospedaliera
Napoli, , Italy
Ospedale S.Gennaro
Napoli, , Italy
A.O. Ospedale Maggiore della carità
Novara, , Italy
Countries
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References
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Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28.
Iveson TJ, Sobrero AF, Yoshino T, Souglakos I, Ou FS, Meyers JP, Shi Q, Grothey A, Saunders MP, Labianca R, Yamanaka T, Boukovinas I, Hollander NH, Galli F, Yamazaki K, Georgoulias V, Kerr R, Oki E, Lonardi S, Harkin A, Rosati G, Paul J. Duration of Adjuvant Doublet Chemotherapy (3 or 6 months) in Patients With High-Risk Stage II Colorectal Cancer. J Clin Oncol. 2021 Feb 20;39(6):631-641. doi: 10.1200/JCO.20.01330. Epub 2021 Jan 13.
Sobrero A, Lonardi S, Rosati G, Di Bartolomeo M, Ronzoni M, Pella N, Scartozzi M, Banzi M, Zampino MG, Pasini F, Marchetti P, Cantore M, Zaniboni A, Rimassa L, Ciuffreda L, Ferrari D, Zagonel V, Maiello E, Barni S, Rulli E, Labianca R; TOSCA Investigators. FOLFOX or CAPOX in Stage II to III Colon Cancer: Efficacy Results of the Italian Three or Six Colon Adjuvant Trial. J Clin Oncol. 2018 May 20;36(15):1478-1485. doi: 10.1200/JCO.2017.76.2187. Epub 2018 Apr 5.
Lonardi S, Sobrero A, Rosati G, Di Bartolomeo M, Ronzoni M, Aprile G, Massida B, Scartozzi M, Banzi M, Zampino MG, Pasini F, Marchetti P, Cantore M, Zaniboni A, Rimassa L, Ciuffreda L, Ferrari D, Barni S, Zagonel V, Maiello E, Rulli E, Labianca R; TOSCA (Three or Six Colon Adjuvant) Investigators. Phase III trial comparing 3-6 months of adjuvant FOLFOX4/XELOX in stage II-III colon cancer: safety and compliance in the TOSCA trial. Ann Oncol. 2016 Nov;27(11):2074-2081. doi: 10.1093/annonc/mdw404. Epub 2016 Aug 29.
Other Identifiers
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2007-000354-31
Identifier Type: -
Identifier Source: org_study_id