FOLFOX-4 3months Versus 6 Months and Bevacizumab as Adjuvant Therapy for Patients With Stage II/III Colon Cancer (TOSCA)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Collaborator:
Mario Negri Institute for Pharmacological Research
Information provided by:
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
ClinicalTrials.gov Identifier:
NCT00646607
First received: March 17, 2008
Last updated: December 14, 2009
Last verified: December 2009
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Purpose
This project consists of two independent, following specific eligibility criteria and different randomisation schemes studies, later on called DURATION study and BEV study. Once randomised in the duration study, patients fulfilling eligibility criteria for BEV study may also be randomized to receive BEV or no BEV, in addition to FOLFOX-4 chemotherapy.
As both are open label studies, there will be no blinding of treatment assignment.
| Condition | Intervention | Phase |
|---|---|---|
|
Colon Cancer |
Drug: FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Trial Investigating the Role of FOLFOX-4 Regimen Duration (3 Versus 6 Months) and Bevacizumab as Adjuvant Therapy for Patients With Stage II/III Colon Cancer |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Drug Information available for:
Fluorouracil
Leucovorin calcium
Oxaliplatin
Levoleucovorin
Bevacizumab
U.S. FDA Resources
Further study details as provided by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente:
Primary Outcome Measures:
- disease free survival (DFS) [ Time Frame: time from randomization date to date of local or regional relapse ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- overall Survival (OS), Toxicity and incidence of adverse events [ Time Frame: from the day of randomisation to the date of death from any cause. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 4100 |
| Study Start Date: | June 2007 |
| Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
3-month FOLFOX-4 (Oxaliplatin, leucovorin and 5-fluorouracil )
|
Drug: FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)
To assess whether a 3-month FOLFOX-4 treatment is at least equivalent to a 6-month FOLFOX-4 treatment
Other Name: FOLFOX 3 vs 6
|
|
Active Comparator: B
6 months FOLFOX-4(Oxaliplatin, leucovorin and 5-fluorouracil )
|
Drug: FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)
standard treatment
Other Name: FOLFOX 3 vs 6
|
Detailed Description:
At the present time the standard treatment for resected colon cancer with high possibility of relapse ("high risk" stage II and all stage III) is represented by the regimen FOLFOX (leucovorin, bolus and infusional 5fluorouracil and oxaliplatin), which is able to increase significantly the disease-free survival (DFS) at 3 and 4 years, whereas the advantage for 5-year overall survival (OS) (which is predicted by the previous parameter) could be observed only with a further increase of follow-up. The conventional duration of chemotherapy is today of 6 months (12 courses every 2 weeks), but this long drug exposure increases the risk of long-term neurotoxicity. A reduction of adjuvant chemotherapy under 6 months was proven effective in other cancers (breast, testis…) and is better tolerated by patients in clinical practice. On the other hand, bevacizumab significantly increases OS and all other parameters when combined with standard chemotherapy in advanced disease.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed AJCC/UICC high-risk stage II or stage III colon cancer . High-risk stage III patients (T4, N+, M0, or any T, N2, M0) may also be further randomized in the BEV study (plus or minus BEV)
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:
- Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections).
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00646607
Hide Study Locations
Contacts
| Contact: Roberto Labianca, MD | +39 035 269859 | rlabian@tin.it |
| Contact: Silvia Rota, Data Manager | +39 0331 490052 | centrotrialgiscad@yahoo.it |
Hide Study LocationsLocations
| Italy | |
| Ospedale Santo Spirito | Not yet recruiting |
| Casale Monferrato, AL, Italy, 15033 | |
| Principal Investigator: Mario Botta, MD | |
| A.O. Umberto I -Università Località Torrette | Recruiting |
| Ancona, AN, Italy, 62020 | |
| Sub-Investigator: Stefano Cascinu, MD | |
| Ospedale Profili | Recruiting |
| Fabriano, AN, Italy, 60044 | |
| Sub-Investigator: Rosa R Silva, MD | |
| Ospedale Mazzoni | Recruiting |
| Ascoli Piceno, AP, Italy, 63100 | |
| Sub-Investigator: Lucia Angelelli, MD | |
| Usl 11 Ospedale Murri | Recruiting |
| Fermo, AP, Italy, 63023 | |
| Sub-Investigator: Lucio Giustini, MD | |
| Università di L'Aquila | Recruiting |
| L'Aquila, AQ, Italy, 67100 | |
| Principal Investigator: Corrado Ficorella, MD | |
| ASL 8 di Arezzo | Recruiting |
| Arezzo, AR, Italy, 52100 | |
| Principal Investigator: Michele Sisani, MD | |
| P.O. Ospedale S.M. Della Gruccia | Recruiting |
| Montevarchi, AR, Italy, 52025 | |
| Principal Investigator: Michela Rinaldini, MD | |
| Ospedale Civile | Recruiting |
| Asti, AT, Italy, 14100 | |
| Sub-Investigator: Franco Testore, MD | |
| Ospedale di Altamura | Recruiting |
| Altamura, BA, Italy, 70100 | |
| Principal Investigator: Giacomo Vessia, MD | |
| A.O. Treviglio-Caravaggio, P.le Ospedale n1 | Recruiting |
| Treviglio, Bergamo, Italy, 24047 | |
| Sub-Investigator: sandro Barni, MD | |
| Ospedale degli Infermi | Not yet recruiting |
| Biella, BI, Italy, 13900 | |
| Sub-Investigator: Mario Clerico, MD | |
| A.O. G.Rummo | Recruiting |
| Benevento, BN, Italy, 82100 | |
| Principal Investigator: Bruno Daniele, MD | |
| Ospedale S.Orsola Fatebenefratelli | Recruiting |
| Brescia, BS, Italy, 15100 | |
| Sub-Investigator: Giordano D Beretta, MD | |
| Fondazione Poliambulanza | Recruiting |
| Brescia, BS, Italy, 15100 | |
| Sub-Investigator: Alberto Zaniboni, MD | |
| Spedali Civili | Recruiting |
| Brescia, BS, Italy, 25100 | |
| Sub-Investigator: Giovanni Marini, MD | |
| Principal Investigator: Giovanni Rangoni, MD | |
| Azienda M.Mellini-Chiara | Recruiting |
| Iseo, BS, Italy, 25049 | |
| Principal Investigator: Giuseppina Arcangeli, MD | |
| Ospedale di Manerbio | Recruiting |
| Manerbio, Bs, Italy, 25025 | |
| Sub-Investigator: Giuseppe Colosini, MD | |
| Ospedale Regionale | Recruiting |
| Bolzano, BZ, Italy, 39100 | |
| Principal Investigator: Claudio Graiff, MD | |
| Ospedale S.Barbara - Asl 7 | Not yet recruiting |
| Iglesias, CA, Italy, 09016 | |
| Principal Investigator: Luciano Virdis, MD | |
| Policlinico Universitario | Recruiting |
| Monserrato, CA, Italy, 09042 | |
| Principal Investigator: Bruno Massidda, MD | |
| Sub-Investigator: Giovanni Mantovani, MD | |
| A.O. S.Sebastiano | Not yet recruiting |
| Caserta, CE, Italy, 81100 | |
| Principal Investigator: Giovanni P Ianniello, MD | |
| AUSL di Lanciano-Vasto | Not yet recruiting |
| Lanciano, CH, Italy, 66034 | |
| Principal Investigator: Domenico Nuzzo, MD | |
| Ospedale S.Lazzaro | Recruiting |
| Alba, CN, Italy, 12051 | |
| Principal Investigator: Roberto Faggiuolo, MD | |
| A.O. S.Croce e Carle | Recruiting |
| Cuneo, CN, Italy, 12100 | |
| Sub-Investigator: Marco C Merlano, MD | |
| Ospedale S.Anna | Recruiting |
| Como, CO, Italy, 22100 | |
| Principal Investigator: Monica Giordano, MD | |
| ospedale Valduce | Recruiting |
| Como, CO, Italy, 22100 | |
| Sub-Investigator: Maria Duro, MD | |
| Ospedale Fatebenefratelli Sacra Famiglia | Not yet recruiting |
| Erba, CO, Italy, 22036 | |
| Principal Investigator: Alfonso Sala, MD | |
| Azienda Istituti Ospitalieri | Recruiting |
| Cremona, CR, Italy, 26100 | |
| Principal Investigator: Rodolfo Passalacqua, MD | |
| Azienda Ospedaliera | Recruiting |
| Catania, CT, Italy, 95100 | |
| Principal Investigator: Calogero Buscarino, MD | |
| ASL 6 - Ospedale Civile | Recruiting |
| Lamezia Terme, CZ, Italy, 88046 | |
| Principal Investigator: Ettore Greco, MD | |
| ASL 11 | Not yet recruiting |
| Empoli, FI, Italy, 50010 | |
| Principal Investigator: Gianmaria Fiorentini, MD | |
| A.O. Ospedale Careggi - Università | Not yet recruiting |
| Firenze, FI, Italy, 50100 | |
| Sub-Investigator: Enrico Mini, MD | |
| Principal Investigator: Roberto Mazzanti, MD | |
| Ospedale S.M.Annunziata-ASL FI | Not yet recruiting |
| Firenze, FI, Italy, 50011 | |
| Principal Investigator: Angela S Ribecco, MD | |
| Ospedale M.Bufalini | Recruiting |
| Cesena, FO, Italy, 47023 | |
| Sub-Investigator: Marina Faedi, MD | |
| A.O. Morgagni-Pierantoni | Recruiting |
| Forlì, FO, Italy, 47100 | |
| Sub-Investigator: Dino Amadori, MD | |
| Università-Ospedale san Martino | Recruiting |
| Genova, GE, Italy, 16133 | |
| Sub-Investigator: Lucia Tixi, MD | |
| Istituto Nazionale ricerca Cancro | Recruiting |
| Genova, GE, Italy, 16132 | |
| Principal Investigator: Silvana Chiara, MD | |
| A.O. Ospedale S.Martino | Recruiting |
| Genova, GE, Italy, 16132 | |
| Sub-Investigator: Alberto Sobrero, MD | |
| Azienda Ospedaliera di Lecco | Recruiting |
| Lecco, LC, Italy, 23900 | |
| Sub-Investigator: Giovanni Ucci, MD | |
| Azienda Usl-6 Università | Recruiting |
| Livorno, LI, Italy, 57121 | |
| Sub-Investigator: Alfredo Falcone, MD | |
| Ospedale di Casalpusterlengo | Recruiting |
| Casalpusterlengo, LO, Italy, 26841 | |
| Principal Investigator: Roberto Franchi, MD | |
| Centro Oncologico Conti | Recruiting |
| Gaeta, Lt, Italy, 04024 | |
| Principal Investigator: Enzo Veltri, MD | |
| Azienda USL LT3 | Not yet recruiting |
| Latina, LT, Italy, 04100 | |
| Principal Investigator: Modesto D'Aprile, MD | |
| Ospedale Unico Versilia | Recruiting |
| Lido Di Camaiore, LU, Italy, 5543 | |
| Principal Investigator: Domenico Amoroso, MD | |
| A.O. Università-Policlinico | Recruiting |
| Messina, ME, Italy, 98123 | |
| Principal Investigator: Vincenzo Adamo, MD | |
| Ospedale Serbelloni | Recruiting |
| Gorgonzola, MI, Italy, 20064 | |
| Sub-Investigator: Luciano Isa, MD | |
| Azienda Ospedaliera | Recruiting |
| Legnano, MI, Italy, 20025 | |
| Principal Investigator: Antonio Luoni, MD | |
| Azienda Ospedale Civile | Not yet recruiting |
| Magenta, MI, Italy, 20013 | |
| Principal Investigator: Alberto DePaoli, MD | |
| Casa di Cura Igea | Recruiting |
| Milano, MI, Italy, 20100 | |
| Sub-Investigator: Gianfranco Pancera, MD | |
| Istituto dei Tumori | Recruiting |
| Milano, MI, Italy, 20100 | |
| Sub-Investigator: Emilio Bajetta, MD | |
| Ospedale S.Carlo Borromeo | Recruiting |
| Milano, MI, Italy, 20123 | |
| Sub-Investigator: Donata Tabiadon, MD | |
| A.O. san Paolo | Recruiting |
| Milano, MI, Italy, 20100 | |
| Sub-Investigator: Paolo Foa, MD | |
| A.O. Ospedale Fatebenefratelli | Recruiting |
| Milano, MI, Italy, 20100 | |
| Principal Investigator: Gabriella Farina, MD | |
| Ospedale Luigi Sacco | Recruiting |
| Milano, MI, Italy, 20100 | |
| Principal Investigator: Elena Piazza, MD | |
| Istituto Europeo di Oncologia | Recruiting |
| Milano, MI, Italy, 20100 | |
| Principal Investigator: Filippo DeBraud, MD | |
| Istituto di Ricerca S.Raffaele | Recruiting |
| Milano, MI, Italy, 20100 | |
| Sub-Investigator: Eugenio Villa, MD | |
| A.O. s.Gerardo | Recruiting |
| Monza, MI, Italy, 20052 | |
| Sub-Investigator: Paolo Bidoli, MD | |
| Istituto Clinico Humanitas | Recruiting |
| Rozzano, MI, Italy, 20133 | |
| Principal Investigator: Armando Santoro, MD | |
| Multimedica | Recruiting |
| Sesto San Giovanni, MI, Italy, 20100 | |
| Principal Investigator: Ornella Gottardi, MD | |
| A.O. Ospedale carlo Poma | Recruiting |
| Mantova, MN, Italy, 46100 | |
| Principal Investigator: Enrico Aitini, MD | |
| Ospedale ramazzini | Recruiting |
| Carpi, MO, Italy, 41012 | |
| Sub-Investigator: Fabrizio Artioli, MD | |
| USL 1 di Massa e Carrara | Recruiting |
| Carrara, MS, Italy, 54033 | |
| Principal Investigator: Maurizio Cantore, MD | |
| Policlinico Giaccone | Recruiting |
| Palermo, PA, Italy, 90127 | |
| Principal Investigator: Sergio Palmeri, MD | |
| Ospedale Oncologico M.Ascoli | Not yet recruiting |
| Palermo, PA, Italy, 90100 | |
| Principal Investigator: Biagio Agostara, MD | |
| Azienda Ospedale Civile | Recruiting |
| Piacenza, PC, Italy, 29100 | |
| Principal Investigator: Giuseppe Cavanna, MD | |
| Istituto Oncologico Veneto | Recruiting |
| Padova, PD, Italy, 35122 | |
| Principal Investigator: Sara Lonardi, MD | |
| Sub-Investigator: Donato Nitti, MD | |
| Ospedale Santo Spirito | Recruiting |
| Penne, PE, Italy, 65100 | |
| Principal Investigator: Donato Natale, MD | |
| Ospedale Santo Spirito | Recruiting |
| Pescara, PE, Italy, 65100 | |
| Principal Investigator: Marco Lombardo, MD | |
| ASL 1 | Recruiting |
| Città Di Castello, PG, Italy, 06012 | |
| Principal Investigator: Stefano Bravi, MD | |
| Centro Riferimento | Recruiting |
| Aviano, PN, Italy, 33081 | |
| Sub-Investigator: Sergio Frustaci, MD | |
| A.O. S.Maria degli Angeli | Recruiting |
| Pordenone, PN, Italy, 33170 | |
| Sub-Investigator: Salvatore Tumolo, MD | |
| Ospedale ASL 4 | Recruiting |
| Prato, PO, Italy, 59100 | |
| Principal Investigator: Angelo Di Leo, MD | |
| Azienda Ospedaliera | Recruiting |
| Parma, PR, Italy, 43100 | |
| Principal Investigator: Francesco leonardi, MD | |
| Ospedale Santa Croce | Recruiting |
| Fano, PS, Italy, 61032 | |
| Principal Investigator: Rodolfo Mattioli, MD | |
| A.O. S.Salvatore | Recruiting |
| Pesaro, PS, Italy, 61100 | |
| Principal Investigator: Vincenzo Catalano, MD | |
| Azienda Ospedaliera San Carlo | Recruiting |
| Potenza, PZ, Italy, 85100 | |
| Principal Investigator: Giuseppe Rosati, MD | |
| Centro Riferimento Oncologico Basilicata | Recruiting |
| Rionero in Volture, PZ, Italy, 85028 | |
| Sub-Investigator: Anna M Bochicchio, MD | |
| Ospedale per gli Infermi | Recruiting |
| Faenza, RA, Italy, 48018 | |
| Sub-Investigator: Angelo Gambi, MD | |
| Ospedale Umberto I | Recruiting |
| Lugo, RA, Italy, 48022 | |
| Sub-Investigator: Giorgio Cruciani, MD | |
| A.O. Santa Maria delle Croci | Recruiting |
| Ravenna, RA, Italy, 48100 | |
| Sub-Investigator: Maurizio Marangolo, MD | |
| Azienda Ospedali Riuniti | Recruiting |
| Reggio Calabria, RC, Italy, 89100 | |
| Sub-Investigator: Mario Nardi, MD | |
| A.O. Santa maria Nuova-Spallanzani | Recruiting |
| Reggio Emilia, RE, Italy, 42100 | |
| Sub-Investigator: Corrado Boni, MD | |
| Ospedale S.Camillo | Recruiting |
| Roma, RM, Italy, 00100 | |
| Principal Investigator: Andrea Mancuso, MD | |
| Policlinico Militare Celio | Active, not recruiting |
| Roma, RM, Italy, 00100 | |
| Ospedale Sant'Andrea | Recruiting |
| Roma, RM, Italy, 00189 | |
| Principal Investigator: Andrea Marchetti, MD | |
| Università Policlinico Umberto I | Recruiting |
| Roma, RM, Italy, 00186 | |
| Sub-Investigator: Enrico Cortesi, MD | |
| Sub-Investigator: Marina DeSeri, MD | |
| Azienda ospedaliera | Recruiting |
| Cattolica, RN, Italy, 47841 | |
| Sub-Investigator: Enzo Pasquini, MD | |
| Ospedale degli Infermi | Recruiting |
| Rimini, RN, Italy, 47900 | |
| Sub-Investigator: Alberto Ravaioli, MD | |
| AULSS 18 di Rovigo | Recruiting |
| Rovigo, RO, Italy, 45100 | |
| Principal Investigator: Felice Pasini, MD | |
| Ospedale Morelli | Recruiting |
| Sondalo, SO, Italy, 23100 | |
| Principal Investigator: Giuseppe Valmadre, MD | |
| A.O. Valtellina e Chiavenna | Recruiting |
| Sondrio, SO, Italy, 23100 | |
| Sub-Investigator: Alessandro Bertolini, MD | |
| A.O. Santa Corona | Recruiting |
| Pietra Ligure, SV, Italy, 17027 | |
| Sub-Investigator: Ugo Folco, MD | |
| Università degli Studi | Recruiting |
| Candiolo, TO, Italy, 10060 | |
| Sub-Investigator: Massimo Aglietta, MD | |
| Ospedale S.Giovanni Bosco | Recruiting |
| Torino, TO, Italy, 10154 | |
| Sub-Investigator: Guido Vietti Ramus, MD | |
| Ospedale Civile | Recruiting |
| Latisana, UD, Italy, 33053 | |
| Principal Investigator: Aldo Iop, MD | |
| Casa di Cura Santa Maria | Recruiting |
| Castellanza, VA, Italy, 21053 | |
| Principal Investigator: Eraldo Bucci, MD | |
| Ulss 5 Ovest Vicentino | Not yet recruiting |
| Montecchio Maggiore, VI, Italy, 36075 | |
| Principal Investigator: Cristina Oliani, MD | |
| Ospedale Negrar | Recruiting |
| Negrar, VR, Italy, 37126 | |
| Principal Investigator: Marco Venturini, MD | |
| Ospedali Riuniti, Largo Barozzi, 1 | Recruiting |
| Bergamo, Italy, 24128 | |
| Principal Investigator: Roberto Labianca, MD | |
| Ospedale S.Leonardo | Not yet recruiting |
| Castellamare Di Stabbia, Italy, 80053 | |
| Principal Investigator: Maddalena Bianco, MD | |
| A.O. Careggi-Università, Viale Pieraccini, 17 | Recruiting |
| Firenze, Italy, 50139 | |
| Sub-Investigator: Francesco Di Costanzo, MD | |
| Azienda Ospedaliera | Recruiting |
| Napoli, Italy, 80131 | |
| Principal Investigator: Vincenzo Montesarchio, MD | |
| Università federico II | Recruiting |
| Napoli, Italy, 80130 | |
| Principal Investigator: Sabino DePlacido, MD | |
| Ospedale S.Gennaro | Not yet recruiting |
| Napoli, Italy, 80131 | |
| Principal Investigator: Luigi Maiorino, MD | |
| A.O. Cardarelli | Recruiting |
| Napoli, Italy, 80131 | |
| Principal Investigator: Giacomo Cartenì, MD | |
| Fondazione Pascale - Istituto Tumori | Recruiting |
| Napoli, Italy, 80130 | |
| Principal Investigator: Giuseppe Iaffaioli, MD | |
| Istituto Tumori- Pascale | Recruiting |
| Napoli, Italy, 80130 | |
| Principal Investigator: Giuseppe Comella, MD | |
| A.O. Ospedale Maggiore della carità | Recruiting |
| Novara, Italy, 28100 | |
| Principal Investigator: Oscar Alabiso, MD | |
| Università Campus Biomedico, Via Emilio Longoni, 83 | Recruiting |
| Roma, Italy, 00155 | |
| Principal Investigator: Giuseppe Tonini, MPr | |
| A.O. S.Giovanni Calabita Fatebenefratelli | Recruiting |
| Roma, Italy, 00186 | |
| Principal Investigator: Domenico Corsi, MD | |
Sponsors and Collaborators
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Mario Negri Institute for Pharmacological Research
Investigators
| Principal Investigator: | Roberto Labianca, MD | Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente |
| Study Chair: | Alberto Sobrero, MD | Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente |
More Information
No publications provided
| Responsible Party: | Roberto Labianca GISCAD President, GISCAD |
| ClinicalTrials.gov Identifier: | NCT00646607 History of Changes |
| Other Study ID Numbers: | 2007-000354-31 |
| Study First Received: | March 17, 2008 |
| Last Updated: | December 14, 2009 |
| Health Authority: | Italy: The Italian Medicines Agency |
Keywords provided by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente:
|
colorectal neoplasm high risk stage II/III |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Fluorouracil Oxaliplatin Bevacizumab Leucovorin |
Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes |
ClinicalTrials.gov processed this record on May 19, 2013