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FOLFOX-4 3months Versus 6 Months and Bevacizumab as Adjuvant Therapy for Patients With Stage II/III Colon Cancer (TOSCA)

Primary Purpose

Colon Cancer

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)
FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)
Sponsored by
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring colorectal neoplasm, high risk, stage II/III

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Santo Spirito
  • A.O. Umberto I -Università Località Torrette
  • Ospedale Profili
  • Ospedale Mazzoni
  • Usl 11 Ospedale Murri
  • Università di L'Aquila
  • ASL 8 di Arezzo
  • P.O. Ospedale S.M. Della Gruccia
  • Ospedale Civile
  • Ospedale di Altamura
  • A.O. Treviglio-Caravaggio, P.le Ospedale n1
  • Ospedale degli Infermi
  • A.O. G.Rummo
  • Fondazione Poliambulanza
  • Ospedale S.Orsola Fatebenefratelli
  • Spedali Civili
  • Azienda M.Mellini-Chiara
  • Ospedale di Manerbio
  • Ospedale Regionale
  • Ospedale S.Barbara - Asl 7
  • Policlinico Universitario
  • A.O. S.Sebastiano
  • AUSL di Lanciano-Vasto
  • Ospedale S.Lazzaro
  • A.O. S.Croce e Carle
  • Ospedale S.Anna
  • ospedale Valduce
  • Ospedale Fatebenefratelli Sacra Famiglia
  • Azienda Istituti Ospitalieri
  • Azienda Ospedaliera
  • ASL 6 - Ospedale Civile
  • ASL 11
  • Ospedale S.M.Annunziata-ASL FI
  • A.O. Ospedale Careggi - Università
  • Ospedale M.Bufalini
  • A.O. Morgagni-Pierantoni
  • A.O. Ospedale S.Martino
  • Istituto Nazionale ricerca Cancro
  • Università-Ospedale san Martino
  • Azienda Ospedaliera di Lecco
  • Azienda Usl-6 Università
  • Ospedale di Casalpusterlengo
  • Centro Oncologico Conti
  • Azienda USL LT3
  • Ospedale Unico Versilia
  • A.O. Università-Policlinico
  • Ospedale Serbelloni
  • Azienda Ospedaliera
  • Azienda Ospedale Civile
  • A.O. Ospedale Fatebenefratelli
  • A.O. san Paolo
  • Casa di Cura Igea
  • Istituto dei Tumori
  • Istituto di Ricerca S.Raffaele
  • Istituto Europeo di Oncologia
  • Ospedale Luigi Sacco
  • Ospedale S.Carlo Borromeo
  • A.O. s.Gerardo
  • Istituto Clinico Humanitas
  • Multimedica
  • A.O. Ospedale carlo Poma
  • Ospedale ramazzini
  • USL 1 di Massa e Carrara
  • Ospedale Oncologico M.Ascoli
  • Policlinico Giaccone
  • Azienda Ospedale Civile
  • Istituto Oncologico Veneto
  • Ospedale Santo Spirito
  • Ospedale Santo Spirito
  • ASL 1
  • Centro Riferimento
  • A.O. S.Maria degli Angeli
  • Ospedale ASL 4
  • Azienda Ospedaliera
  • Ospedale Santa Croce
  • A.O. S.Salvatore
  • Azienda Ospedaliera San Carlo
  • Centro Riferimento Oncologico Basilicata
  • Ospedale per gli Infermi
  • Ospedale Umberto I
  • A.O. Santa Maria delle Croci
  • Azienda Ospedali Riuniti
  • A.O. Santa maria Nuova-Spallanzani
  • Ospedale S.Camillo
  • Policlinico Militare Celio
  • Università Policlinico Umberto I
  • Ospedale Sant'Andrea
  • Azienda ospedaliera
  • Ospedale degli Infermi
  • AULSS 18 di Rovigo
  • Ospedale Morelli
  • A.O. Valtellina e Chiavenna
  • A.O. Santa Corona
  • Università degli Studi
  • Ospedale S.Giovanni Bosco
  • Ospedale Civile
  • Casa di Cura Santa Maria
  • Ulss 5 Ovest Vicentino
  • Ospedale Negrar
  • Ospedali Riuniti, Largo Barozzi, 1
  • Ospedale S.Leonardo
  • A.O. Careggi-Università, Viale Pieraccini, 17
  • Fondazione Pascale - Istituto Tumori
  • Istituto Tumori- Pascale
  • Università federico II
  • A.O. Cardarelli
  • Azienda Ospedaliera
  • Ospedale S.Gennaro
  • A.O. Ospedale Maggiore della carità
  • Università Campus Biomedico, Via Emilio Longoni, 83
  • A.O. S.Giovanni Calabita Fatebenefratelli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

FOLFOX-4 (infusional 5-Fluouracil, leucovorin and oxaliplatin) for 3 months or XELOX (capecitabine and oxaliplatin) for 12 weeks.

FOLFOX-4 (infusional 5-Fluouracil, leucovorin and oxaliplatin) for 6 months or XELOX (capecitabine and oxaliplatin) for 24 weeks.

Outcomes

Primary Outcome Measures

disease free survival (DFS)

Secondary Outcome Measures

overall Survival (OS), Toxicity and incidence of adverse events

Full Information

First Posted
March 17, 2008
Last Updated
November 25, 2014
Sponsor
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Collaborators
Mario Negri Institute for Pharmacological Research
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1. Study Identification

Unique Protocol Identification Number
NCT00646607
Brief Title
FOLFOX-4 3months Versus 6 Months and Bevacizumab as Adjuvant Therapy for Patients With Stage II/III Colon Cancer
Acronym
TOSCA
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Collaborators
Mario Negri Institute for Pharmacological Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
colorectal neoplasm, high risk, stage II/III

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3756 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
FOLFOX-4 (infusional 5-Fluouracil, leucovorin and oxaliplatin) for 3 months or XELOX (capecitabine and oxaliplatin) for 12 weeks.
Arm Title
B
Arm Type
Active Comparator
Arm Description
FOLFOX-4 (infusional 5-Fluouracil, leucovorin and oxaliplatin) for 6 months or XELOX (capecitabine and oxaliplatin) for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)
Other Intervention Name(s)
FOLFOX 3 vs 6
Intervention Description
To assess whether a 3-month FOLFOX-4 treatment is at least equivalent to a 6-month FOLFOX-4 treatment
Intervention Type
Drug
Intervention Name(s)
FOLFOX (Oxaliplatin, 5Fluorouracil, Lederfolin)
Other Intervention Name(s)
FOLFOX 3 vs 6
Intervention Description
standard treatment
Primary Outcome Measure Information:
Title
disease free survival (DFS)
Time Frame
time from randomization date to date of local or regional relapse
Secondary Outcome Measure Information:
Title
overall Survival (OS), Toxicity and incidence of adverse events
Time Frame
from the day of randomisation to the date of death from any cause.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Labianca, MD
Organizational Affiliation
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alberto Sobrero, MD
Organizational Affiliation
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale Santo Spirito
City
Casale Monferrato
State/Province
AL
ZIP/Postal Code
15033
Country
Italy
Facility Name
A.O. Umberto I -Università Località Torrette
City
Ancona
State/Province
AN
ZIP/Postal Code
62020
Country
Italy
Facility Name
Ospedale Profili
City
Fabriano
State/Province
AN
ZIP/Postal Code
60044
Country
Italy
Facility Name
Ospedale Mazzoni
City
Ascoli Piceno
State/Province
AP
ZIP/Postal Code
63100
Country
Italy
Facility Name
Usl 11 Ospedale Murri
City
Fermo
State/Province
AP
ZIP/Postal Code
63023
Country
Italy
Facility Name
Università di L'Aquila
City
L'Aquila
State/Province
AQ
ZIP/Postal Code
67100
Country
Italy
Facility Name
ASL 8 di Arezzo
City
Arezzo
State/Province
AR
ZIP/Postal Code
52100
Country
Italy
Facility Name
P.O. Ospedale S.M. Della Gruccia
City
Montevarchi
State/Province
AR
ZIP/Postal Code
52025
Country
Italy
Facility Name
Ospedale Civile
City
Asti
State/Province
AT
ZIP/Postal Code
14100
Country
Italy
Facility Name
Ospedale di Altamura
City
Altamura
State/Province
BA
ZIP/Postal Code
70100
Country
Italy
Facility Name
A.O. Treviglio-Caravaggio, P.le Ospedale n1
City
Treviglio
State/Province
Bergamo
ZIP/Postal Code
24047
Country
Italy
Facility Name
Ospedale degli Infermi
City
Biella
State/Province
BI
ZIP/Postal Code
13900
Country
Italy
Facility Name
A.O. G.Rummo
City
Benevento
State/Province
BN
ZIP/Postal Code
82100
Country
Italy
Facility Name
Fondazione Poliambulanza
City
Brescia
State/Province
BS
ZIP/Postal Code
15100
Country
Italy
Facility Name
Ospedale S.Orsola Fatebenefratelli
City
Brescia
State/Province
BS
ZIP/Postal Code
15100
Country
Italy
Facility Name
Spedali Civili
City
Brescia
State/Province
BS
ZIP/Postal Code
25100
Country
Italy
Facility Name
Azienda M.Mellini-Chiara
City
Iseo
State/Province
BS
ZIP/Postal Code
25049
Country
Italy
Facility Name
Ospedale di Manerbio
City
Manerbio
State/Province
Bs
ZIP/Postal Code
25025
Country
Italy
Facility Name
Ospedale Regionale
City
Bolzano
State/Province
BZ
ZIP/Postal Code
39100
Country
Italy
Facility Name
Ospedale S.Barbara - Asl 7
City
Iglesias
State/Province
CA
ZIP/Postal Code
09016
Country
Italy
Facility Name
Policlinico Universitario
City
Monserrato
State/Province
CA
ZIP/Postal Code
09042
Country
Italy
Facility Name
A.O. S.Sebastiano
City
Caserta
State/Province
CE
ZIP/Postal Code
81100
Country
Italy
Facility Name
AUSL di Lanciano-Vasto
City
Lanciano
State/Province
CH
ZIP/Postal Code
66034
Country
Italy
Facility Name
Ospedale S.Lazzaro
City
Alba
State/Province
CN
ZIP/Postal Code
12051
Country
Italy
Facility Name
A.O. S.Croce e Carle
City
Cuneo
State/Province
CN
ZIP/Postal Code
12100
Country
Italy
Facility Name
Ospedale S.Anna
City
Como
State/Province
CO
ZIP/Postal Code
22100
Country
Italy
Facility Name
ospedale Valduce
City
Como
State/Province
CO
ZIP/Postal Code
22100
Country
Italy
Facility Name
Ospedale Fatebenefratelli Sacra Famiglia
City
Erba
State/Province
CO
ZIP/Postal Code
22036
Country
Italy
Facility Name
Azienda Istituti Ospitalieri
City
Cremona
State/Province
CR
ZIP/Postal Code
26100
Country
Italy
Facility Name
Azienda Ospedaliera
City
Catania
State/Province
CT
ZIP/Postal Code
95100
Country
Italy
Facility Name
ASL 6 - Ospedale Civile
City
Lamezia Terme
State/Province
CZ
ZIP/Postal Code
88046
Country
Italy
Facility Name
ASL 11
City
Empoli
State/Province
FI
ZIP/Postal Code
50010
Country
Italy
Facility Name
Ospedale S.M.Annunziata-ASL FI
City
Firenze
State/Province
FI
ZIP/Postal Code
50011
Country
Italy
Facility Name
A.O. Ospedale Careggi - Università
City
Firenze
State/Province
FI
ZIP/Postal Code
50100
Country
Italy
Facility Name
Ospedale M.Bufalini
City
Cesena
State/Province
FO
ZIP/Postal Code
47023
Country
Italy
Facility Name
A.O. Morgagni-Pierantoni
City
Forlì
State/Province
FO
ZIP/Postal Code
47100
Country
Italy
Facility Name
A.O. Ospedale S.Martino
City
Genova
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
Facility Name
Istituto Nazionale ricerca Cancro
City
Genova
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
Facility Name
Università-Ospedale san Martino
City
Genova
State/Province
GE
ZIP/Postal Code
16133
Country
Italy
Facility Name
Azienda Ospedaliera di Lecco
City
Lecco
State/Province
LC
ZIP/Postal Code
23900
Country
Italy
Facility Name
Azienda Usl-6 Università
City
Livorno
State/Province
LI
ZIP/Postal Code
57121
Country
Italy
Facility Name
Ospedale di Casalpusterlengo
City
Casalpusterlengo
State/Province
LO
ZIP/Postal Code
26841
Country
Italy
Facility Name
Centro Oncologico Conti
City
Gaeta
State/Province
Lt
ZIP/Postal Code
04024
Country
Italy
Facility Name
Azienda USL LT3
City
Latina
State/Province
LT
ZIP/Postal Code
04100
Country
Italy
Facility Name
Ospedale Unico Versilia
City
Lido di Camaiore
State/Province
LU
ZIP/Postal Code
5543
Country
Italy
Facility Name
A.O. Università-Policlinico
City
Messina
State/Province
ME
ZIP/Postal Code
98123
Country
Italy
Facility Name
Ospedale Serbelloni
City
Gorgonzola
State/Province
MI
ZIP/Postal Code
20064
Country
Italy
Facility Name
Azienda Ospedaliera
City
Legnano
State/Province
MI
ZIP/Postal Code
20025
Country
Italy
Facility Name
Azienda Ospedale Civile
City
Magenta
State/Province
MI
ZIP/Postal Code
20013
Country
Italy
Facility Name
A.O. Ospedale Fatebenefratelli
City
Milano
State/Province
MI
ZIP/Postal Code
20100
Country
Italy
Facility Name
A.O. san Paolo
City
Milano
State/Province
MI
ZIP/Postal Code
20100
Country
Italy
Facility Name
Casa di Cura Igea
City
Milano
State/Province
MI
ZIP/Postal Code
20100
Country
Italy
Facility Name
Istituto dei Tumori
City
Milano
State/Province
MI
ZIP/Postal Code
20100
Country
Italy
Facility Name
Istituto di Ricerca S.Raffaele
City
Milano
State/Province
MI
ZIP/Postal Code
20100
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
State/Province
MI
ZIP/Postal Code
20100
Country
Italy
Facility Name
Ospedale Luigi Sacco
City
Milano
State/Province
MI
ZIP/Postal Code
20100
Country
Italy
Facility Name
Ospedale S.Carlo Borromeo
City
Milano
State/Province
MI
ZIP/Postal Code
20123
Country
Italy
Facility Name
A.O. s.Gerardo
City
Monza
State/Province
MI
ZIP/Postal Code
20052
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
MI
ZIP/Postal Code
20133
Country
Italy
Facility Name
Multimedica
City
Sesto San Giovanni
State/Province
MI
ZIP/Postal Code
20100
Country
Italy
Facility Name
A.O. Ospedale carlo Poma
City
Mantova
State/Province
MN
ZIP/Postal Code
46100
Country
Italy
Facility Name
Ospedale ramazzini
City
Carpi
State/Province
MO
ZIP/Postal Code
41012
Country
Italy
Facility Name
USL 1 di Massa e Carrara
City
Carrara
State/Province
MS
ZIP/Postal Code
54033
Country
Italy
Facility Name
Ospedale Oncologico M.Ascoli
City
Palermo
State/Province
PA
ZIP/Postal Code
90100
Country
Italy
Facility Name
Policlinico Giaccone
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Facility Name
Azienda Ospedale Civile
City
Piacenza
State/Province
PC
ZIP/Postal Code
29100
Country
Italy
Facility Name
Istituto Oncologico Veneto
City
Padova
State/Province
PD
ZIP/Postal Code
35122
Country
Italy
Facility Name
Ospedale Santo Spirito
City
Penne
State/Province
PE
ZIP/Postal Code
65100
Country
Italy
Facility Name
Ospedale Santo Spirito
City
Pescara
State/Province
PE
ZIP/Postal Code
65100
Country
Italy
Facility Name
ASL 1
City
Città di Castello
State/Province
PG
ZIP/Postal Code
06012
Country
Italy
Facility Name
Centro Riferimento
City
Aviano
State/Province
PN
ZIP/Postal Code
33081
Country
Italy
Facility Name
A.O. S.Maria degli Angeli
City
Pordenone
State/Province
PN
ZIP/Postal Code
33170
Country
Italy
Facility Name
Ospedale ASL 4
City
Prato
State/Province
PO
ZIP/Postal Code
59100
Country
Italy
Facility Name
Azienda Ospedaliera
City
Parma
State/Province
PR
ZIP/Postal Code
43100
Country
Italy
Facility Name
Ospedale Santa Croce
City
Fano
State/Province
PS
ZIP/Postal Code
61032
Country
Italy
Facility Name
A.O. S.Salvatore
City
Pesaro
State/Province
PS
ZIP/Postal Code
61100
Country
Italy
Facility Name
Azienda Ospedaliera San Carlo
City
Potenza
State/Province
PZ
ZIP/Postal Code
85100
Country
Italy
Facility Name
Centro Riferimento Oncologico Basilicata
City
Rionero in Volture
State/Province
PZ
ZIP/Postal Code
85028
Country
Italy
Facility Name
Ospedale per gli Infermi
City
Faenza
State/Province
RA
ZIP/Postal Code
48018
Country
Italy
Facility Name
Ospedale Umberto I
City
Lugo
State/Province
RA
ZIP/Postal Code
48022
Country
Italy
Facility Name
A.O. Santa Maria delle Croci
City
Ravenna
State/Province
RA
ZIP/Postal Code
48100
Country
Italy
Facility Name
Azienda Ospedali Riuniti
City
Reggio calabria
State/Province
RC
ZIP/Postal Code
89100
Country
Italy
Facility Name
A.O. Santa maria Nuova-Spallanzani
City
Reggio Emilia
State/Province
RE
ZIP/Postal Code
42100
Country
Italy
Facility Name
Ospedale S.Camillo
City
Roma
State/Province
RM
ZIP/Postal Code
00100
Country
Italy
Facility Name
Policlinico Militare Celio
City
Roma
State/Province
RM
ZIP/Postal Code
00100
Country
Italy
Facility Name
Università Policlinico Umberto I
City
Roma
State/Province
RM
ZIP/Postal Code
00186
Country
Italy
Facility Name
Ospedale Sant'Andrea
City
Roma
State/Province
RM
ZIP/Postal Code
00189
Country
Italy
Facility Name
Azienda ospedaliera
City
Cattolica
State/Province
RN
ZIP/Postal Code
47841
Country
Italy
Facility Name
Ospedale degli Infermi
City
Rimini
State/Province
RN
ZIP/Postal Code
47900
Country
Italy
Facility Name
AULSS 18 di Rovigo
City
Rovigo
State/Province
RO
ZIP/Postal Code
45100
Country
Italy
Facility Name
Ospedale Morelli
City
Sondalo
State/Province
SO
ZIP/Postal Code
23100
Country
Italy
Facility Name
A.O. Valtellina e Chiavenna
City
Sondrio
State/Province
SO
ZIP/Postal Code
23100
Country
Italy
Facility Name
A.O. Santa Corona
City
Pietra Ligure
State/Province
SV
ZIP/Postal Code
17027
Country
Italy
Facility Name
Università degli Studi
City
Candiolo
State/Province
TO
ZIP/Postal Code
10060
Country
Italy
Facility Name
Ospedale S.Giovanni Bosco
City
Torino
State/Province
TO
ZIP/Postal Code
10154
Country
Italy
Facility Name
Ospedale Civile
City
Latisana
State/Province
UD
ZIP/Postal Code
33053
Country
Italy
Facility Name
Casa di Cura Santa Maria
City
Castellanza
State/Province
VA
ZIP/Postal Code
21053
Country
Italy
Facility Name
Ulss 5 Ovest Vicentino
City
Montecchio Maggiore
State/Province
VI
ZIP/Postal Code
36075
Country
Italy
Facility Name
Ospedale Negrar
City
Negrar
State/Province
VR
ZIP/Postal Code
37126
Country
Italy
Facility Name
Ospedali Riuniti, Largo Barozzi, 1
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Facility Name
Ospedale S.Leonardo
City
Castellamare di Stabbia
ZIP/Postal Code
80053
Country
Italy
Facility Name
A.O. Careggi-Università, Viale Pieraccini, 17
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Fondazione Pascale - Istituto Tumori
City
Napoli
ZIP/Postal Code
80130
Country
Italy
Facility Name
Istituto Tumori- Pascale
City
Napoli
ZIP/Postal Code
80130
Country
Italy
Facility Name
Università federico II
City
Napoli
ZIP/Postal Code
80130
Country
Italy
Facility Name
A.O. Cardarelli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale S.Gennaro
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
A.O. Ospedale Maggiore della carità
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Università Campus Biomedico, Via Emilio Longoni, 83
City
Roma
ZIP/Postal Code
00155
Country
Italy
Facility Name
A.O. S.Giovanni Calabita Fatebenefratelli
City
Roma
ZIP/Postal Code
00186
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
36306483
Citation
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.
Results Reference
derived
PubMed Identifier
33439695
Citation
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. Erratum In: J Clin Oncol. 2021 May 20;39(15):1691.
Results Reference
derived
PubMed Identifier
29620994
Citation
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.
Results Reference
derived
PubMed Identifier
27573560
Citation
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. Erratum In: Ann Oncol. 2017 Dec 1;28(12 ):3110.
Results Reference
derived

Learn more about this trial

FOLFOX-4 3months Versus 6 Months and Bevacizumab as Adjuvant Therapy for Patients With Stage II/III Colon Cancer

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