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Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach (ITACA-S)

Primary Purpose

Adenocarcinoma of the Stomach, Adenocarcinoma of the Gastroesophageal Junction

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Irinotecan, Leucovorin, 5-Fluorouracil, Docetaxel, Cisplatin
Leucovorin, 5-Fluorouracil
Sponsored by
Mario Negri Institute for Pharmacological Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Stomach focused on measuring adenocarcinoma of the stomach, adenocarcinoma of the gastroesophageal junction

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically proven adenocarcinoma of the stomach or gastroesophageal junction without gross or microscopic evidence of residual disease after surgery with curative intent;
  • Subtotal or total gastrectomy with at least D1 dissection;
  • Gastroesophageal junction adenocarcinoma extending to the stomach with the center lying 2 to 5 cm below the anatomic esophago-gastric junction;
  • Patients with nodal involvement (pN+) or patients without nodal involvement (pN0) with pT2b-3-4. It is recommended to examine at least 15 lymph nodes;
  • Age between 18 and 75 years;
  • ECOG performance status 0-1;
  • No previous chemotherapy and/or radiotherapy;
  • Complete staging procedures within 3 months prior to randomization;

  • Laboratory requirement (within 8 days prior to randomization):

    • Haematology (Neutrophils > 2.0 x 109 /L, Platelet > 100 x 109 /L, Hemoglobin > 10g/dL);
    • Hepatic function (Total bilirubin < 1 UNL, ASAT (SGOT) and ALAT (SGPT) < 2.5xUNL, Alkaline phosphatase < 2.5xUNL. Patients with ASAT or ALAT > 1.5xUNL associated with alkaline phosphatase > 2.5XUNL are not eligible.)
    • Renal function (Creatinine < 1.5 UNL. In presence of borderline values, the calculated creatinine clearance according to Cockroft-Gault formula, 60 ML/min.
  • Recovery from acute effects of surgery. The first infusion of study chemotherapy should be administered 3 to 8 weeks after surgery treatment;
  • Written informed consent signed and dated before randomization procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirement.

Exclusion Criteria:

  • Non-radical surgery as assessed microscopically (no tumor-free margin of resection, positive biopsy of peritoneal suspicious lesions);
  • Synchronous metastases, even curatively resected;
  • Pregnant or lactating patients; patients with reproductive potential must implement adequate contraceptive measures;

  • Prior or concurrent history of:

    • positive HIV serology,
    • chronic diarrhoea,
    • chronic bowel inflammation or subobstruction,
    • neoplasm other than gastric cancer, except for: curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix,
    • previous history of myocardial infarction within 1 year from study entry,
    • hypersensitivity reaction to polysorbate 80;

  • Presence of other systemic disease limiting drug administration and influencing patient survival:

    • uncontrolled hypertension,
    • high-risk uncontrolled arrhythmia,
    • unstable angina pectoris;

  • Symptomatic

    • peripheral neuropathy,
    • altered hearing > 2 grade by NCIC-CTG criteria;
  • Active uncontrolled infection.
  • Definite contra-indications for the use of corticosteroids: unstable diabetes mellitus, active peptic ulcer;

  • Concurrent administration of:

    • corticosteroids or equivalent except as use for the prophylactic medication regimen, treatment of acute hypersensitivity reactions or unless chronic treatment (initiated > 6 months prior to study entry) at low doses (< 20mg methylprednisolone or equivalent);
    • any other experimental drug under investigation: concurrent treatment with any other anticancer therapy, growth factors with preventive intent

Sites / Locations

  • ASL 6 - Fabriano
  • Ospedale Civile di Senigallia
  • dell'Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I
  • Presidio Ospedaliero di Ariano Irpino
  • A.O. "Ospedale Treviglio-Caravaggio"
  • P.O. di Monserrato - Policlinico Universitario di Cagliari
  • P.O. di Monserrato
  • Ospedale Civile "Ferrari"
  • Presidio Ospedaliero di Lamezia Terme
  • Ospedale "San Francesco" di Paola
  • P.O. S. Lazzaro
  • Ospedale Santa Maria Annunziata
  • Ospedale "San Giuseppe"
  • Ospedale Civico di Carrara
  • A.O "San Gerardo" di Monza
  • Istituto Clinico Humanitas
  • Ospedale IRCCS Policlinico di San Donato
  • Presidio Ospedaliero "Serbelloni"di Gorgonzola
  • Ospedale "B.Ramazzini"
  • Presidio Ospedaliero "Santa Maria delle Grazie"
  • Ospedale Civile di Este
  • Ospedale di Città di Castello - ASL 1 Umbria
  • Ospedale di Marsciano - Servizio Oncologico
  • Ospedale "Santa Croce"
  • Ospedale Civile "San Massimo"
  • Centro di Riferimento Oncologico - INT
  • Centro di Riferimento Oncologico di Basilicata
  • P.O. di Faenza
  • P.O. Umberto I di Lugo
  • Ospedale Civile di Siderno
  • Ospedale "San Luca"
  • Istituto per la Ricerca e la Cura del Cancro di Candiolo
  • Ospedale Civile di Latisana
  • Azienda Ospedaliera S. Maria
  • Presidio Ospedaliero di Saronno - A.O. "Ospedale di Circolo di Busto Arsizio"
  • A.O. "Ospedale di Circolo di Busto Arsizio"
  • Ospedale di Legnago
  • Ospedale di Montecchio Maggiore
  • Ospedale. S. Donato
  • A.O. "G. Rummo"
  • Ospedali "Riuniti"
  • Ospedale degli Infermi di Biella
  • Ospedale Maggiore-Bellaria
  • A.O.Policlinico "S.Orsola-Malpighi"
  • Ospedale Sant'Orsola - Fatebenefratelli
  • Casa di Cura Poliambulanza di Brescia
  • Spedali Civili
  • P.O. Vittorio Emanuele
  • Ospedale Garibaldi in Nesima
  • A.O. Sant'Anna
  • Ospedale "Valduce"
  • A.O. "Ospedale Maggiore" di Crema
  • Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
  • A.O. "S.Croce e Carle"
  • Azienda Ospedaliera Universitaria "S.Anna"
  • A.O. Universitaria Careggi
  • A.O. "G.B.Morgagni-L.Pierantoni
  • E.O. Ospedali Galliera di Genova
  • Istituto Nazionale per la Ricerca sul Cancro
  • P.O. "A.Manzoni" di Lecco
  • Azienda USL 6 - P.O. Livorno
  • Ospedale Civile di Casalpusterlengo
  • Ospedale "Campo di Marte"
  • A.O. "C.Poma"
  • Istituto Scientifico Universitario San Raffaele
  • Istituto Nazionale per la cura dei tumori
  • Istituto Europeo di Oncologia
  • Azienda Ospedaliera "Ospedale San Carlo Borromeo"
  • Azienda Ospedaliera "Luigi Sacco" Polo Universitario
  • Azienda Ospedaliera "San Paolo" Polo Universitario
  • A.O. "D.Cotugno"
  • A.O.R.N. "Antonio Cardarelli"
  • Azienda Ospedaliera Universitaria "Federico II"
  • Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Pascale"
  • Azienda Ospedaliera "Maggiore della Carità"
  • Azienda Ospedaliera di Padova
  • Ospedali "Civico e Benfratelli - G. Di Cristina - Maurizio Ascoli"
  • Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"di Palermo
  • Azienda Ospedaliera di Parma
  • A.O."Ospedale S.Salvatore"
  • Ospedale Civile dello "Spirito Santo"
  • Ospedale Civile di Piacenza
  • Azienda Ospedaliera-Universitaria Pisana
  • A.O. "Santa Maria degli Angeli"
  • Ospedale "San Carlo"di Potenza
  • Ospedale "Misericordia e Dolce"
  • P.O. di Ravenna - Azienda Unità Sanitaria Locale di Ravenna
  • A.O. "Bianchi-Melacrino-Morelli"
  • Arcispedale Santa Maria Nuova
  • Ospedale "Infermi"
  • Azienda Ospedaliera Universitaria "Policlinico Tor Vergata"
  • Policlinico Umberto I
  • Ospedale Fatebenefratelli "San Giovanni Calibita"
  • Istituto Nazionale di Riposo e Cura per Anziani
  • Istituto Dermopatico dell'Immacolata - IRCCS
  • Azienda Unità Sanitaria Locale n°1 Sassari
  • Ospedale Civile di Sassari
  • A.O. della Valtellina e della Valchiavenna
  • Ospedale San Giovanni Battista di Torino
  • A.O."Ospedale di Circolo e Fondazione Macchi"
  • A.O. Istituti Ospitalieri di Verona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sequential regimen

De Gramont regimen

Arm Description

Sequential treatment with CPT-11 plus Fluorouracil (FU), folinic acid (LV) and Docetaxel (TXT) plus Cisplatin (CDDP)

Fluorouracil (5-FU), folinic acid (LV)

Outcomes

Primary Outcome Measures

Progression Free Survival will be defined as the time from date of randomisation to date of first appearance of local, regional or distant relapse, or death from any cause; patients alive without relapse will be censored at date last known to be alive.

Secondary Outcome Measures

OS will be defined as the time from date of randomisation to date of death by any cause, with living patients censored at date last known to be alive
Toxicity, graded according to the NCI-CTG Expanded Common Toxicity Criteria
Adverse events

Full Information

First Posted
July 9, 2012
Last Updated
July 17, 2014
Sponsor
Mario Negri Institute for Pharmacological Research
Collaborators
Aventis Pharmaceuticals, Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente, Gruppo Oncologico Italiano di Ricerca Clinica, Gruppo Oncologico del Nord-Ovest, Italian Trial in Medical Oncology, Southern Italy Cooperative Oncology Group, Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori, Oncotech
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1. Study Identification

Unique Protocol Identification Number
NCT01640782
Brief Title
Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach
Acronym
ITACA-S
Official Title
Open Label, Randomised, Multicenter Phase III Study of Adjuvant Chemotherapy in Radically Resected Adenocarcinoma of the Stomach or Gastroesophageal Junction: Comparison of a Sequential Treatment (CPT-11+5-FU/LV --> TXT+CDDP) Versus a 5-FU/LV Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mario Negri Institute for Pharmacological Research
Collaborators
Aventis Pharmaceuticals, Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente, Gruppo Oncologico Italiano di Ricerca Clinica, Gruppo Oncologico del Nord-Ovest, Italian Trial in Medical Oncology, Southern Italy Cooperative Oncology Group, Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori, Oncotech

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Open label, randomised, multicenter, superiority study for efficacy. Patients with histologically proven adenocarcinoma of the stomach or gastroesophageal junction without gross or microscopic evidence of residual disease after surgery with curative intent and fulfilling all the inclusion/exclusion criteria are eligible for this study.
Detailed Description
Open label, randomised, multicenter, superiority study for efficacy. Patients with histologically proven adenocarcinoma of the stomach or gastroesophageal junction without gross or microscopic evidence of residual disease after surgery with curative intent and fulfilling all the inclusion/exclusion criteria are eligible for this study. Allocation to treatment will be done centrally using a randomisation scheme and will be stratified by center and nodal involvement (N- vs. N+). Access to random system will be allowed by phone or via web. All included patients in both groups will received fixed period of 18 weeks of treatment unless unacceptable toxicity or disease relapse during treatment. After cessation of therapy, patients will have a follow-up period while not receiving further treatment. After relapse further chemotherapy is left to the investigator's judgement. When the last patient is randomised, follow-up will be truncated at the achievement of the required number of events. Time to progression and time to death are the main study outcomes. During the course of the trial, an independent Data and Safety Monitoring Board (DSMB) will advise the Steering Committee on efficacy and/or safety aspects of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Stomach, Adenocarcinoma of the Gastroesophageal Junction
Keywords
adenocarcinoma of the stomach, adenocarcinoma of the gastroesophageal junction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequential regimen
Arm Type
Experimental
Arm Description
Sequential treatment with CPT-11 plus Fluorouracil (FU), folinic acid (LV) and Docetaxel (TXT) plus Cisplatin (CDDP)
Arm Title
De Gramont regimen
Arm Type
Active Comparator
Arm Description
Fluorouracil (5-FU), folinic acid (LV)
Intervention Type
Drug
Intervention Name(s)
Irinotecan, Leucovorin, 5-Fluorouracil, Docetaxel, Cisplatin
Intervention Description
Irinotecan (CPT-11) 180 mg/m2, given as 60 min. i.v. infusion on day 1 every 2 weeks followed by Leucovorin (LV) 100 mg/m2, given as a 2h i.v. infusion on days 1 and 2 every 2 weeks followed by 5-Fluorouracil (5-FU) 400 mg/m2 given as bolus, and then 5-Fluorouracil (5-FU) 600 mg/m2 given as a 22h continuous infusion on days 1 and 2, every 2 weeks for 4 administrations. After 3 weeks from last infusion: Docetaxel (TXT) 75 mg/m2, given as a 1h i.v. infusion on day 1 followed by Cisplatin (CDDP) 75 mg/m2, given as a 1h i.v. infusion on.day 1, every 3 weeks, for 3 cycles.
Intervention Type
Drug
Intervention Name(s)
Leucovorin, 5-Fluorouracil
Intervention Description
Leucovorin (LV) 100 mg/m2, given as a 2h i.v. infusion on days 1 and 2 every 2 weeks followed by 5-Fluorouracil (5-FU) 400 mg/m2 given as bolus, and then 5-Fluorouracil (5-FU) 600 mg/m2 given as a 22h continuous infusion on days 1 and 2, every 2 weeks for 9 administrations.
Primary Outcome Measure Information:
Title
Progression Free Survival will be defined as the time from date of randomisation to date of first appearance of local, regional or distant relapse, or death from any cause; patients alive without relapse will be censored at date last known to be alive.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
OS will be defined as the time from date of randomisation to date of death by any cause, with living patients censored at date last known to be alive
Time Frame
3 years
Title
Toxicity, graded according to the NCI-CTG Expanded Common Toxicity Criteria
Time Frame
3 years
Title
Adverse events
Time Frame
3 years

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 proven adenocarcinoma of the stomach or gastroesophageal junction without gross or microscopic evidence of residual disease after surgery with curative intent; Subtotal or total gastrectomy with at least D1 dissection; Gastroesophageal junction adenocarcinoma extending to the stomach with the center lying 2 to 5 cm below the anatomic esophago-gastric junction; Patients with nodal involvement (pN+) or patients without nodal involvement (pN0) with pT2b-3-4. It is recommended to examine at least 15 lymph nodes; Age between 18 and 75 years; ECOG performance status 0-1; No previous chemotherapy and/or radiotherapy; Complete staging procedures within 3 months prior to randomization; Laboratory requirement (within 8 days prior to randomization): Haematology (Neutrophils > 2.0 x 109 /L, Platelet > 100 x 109 /L, Hemoglobin > 10g/dL); Hepatic function (Total bilirubin < 1 UNL, ASAT (SGOT) and ALAT (SGPT) < 2.5xUNL, Alkaline phosphatase < 2.5xUNL. Patients with ASAT or ALAT > 1.5xUNL associated with alkaline phosphatase > 2.5XUNL are not eligible.) Renal function (Creatinine < 1.5 UNL. In presence of borderline values, the calculated creatinine clearance according to Cockroft-Gault formula, 60 ML/min. Recovery from acute effects of surgery. The first infusion of study chemotherapy should be administered 3 to 8 weeks after surgery treatment; Written informed consent signed and dated before randomization procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirement. Exclusion Criteria: Non-radical surgery as assessed microscopically (no tumor-free margin of resection, positive biopsy of peritoneal suspicious lesions); Synchronous metastases, even curatively resected; Pregnant or lactating patients; patients with reproductive potential must implement adequate contraceptive measures; Prior or concurrent history of: positive HIV serology, chronic diarrhoea, chronic bowel inflammation or subobstruction, neoplasm other than gastric cancer, except for: curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, previous history of myocardial infarction within 1 year from study entry, hypersensitivity reaction to polysorbate 80; Presence of other systemic disease limiting drug administration and influencing patient survival: uncontrolled hypertension, high-risk uncontrolled arrhythmia, unstable angina pectoris; Symptomatic peripheral neuropathy, altered hearing > 2 grade by NCIC-CTG criteria; Active uncontrolled infection. Definite contra-indications for the use of corticosteroids: unstable diabetes mellitus, active peptic ulcer; Concurrent administration of: corticosteroids or equivalent except as use for the prophylactic medication regimen, treatment of acute hypersensitivity reactions or unless chronic treatment (initiated > 6 months prior to study entry) at low doses (< 20mg methylprednisolone or equivalent); any other experimental drug under investigation: concurrent treatment with any other anticancer therapy, growth factors with preventive intent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilio Bajetta, MD
Organizational Affiliation
Istituto Nazionale Per lo Studio e la Cura dei Tumori Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASL 6 - Fabriano
City
Fabriano
State/Province
Ancona
ZIP/Postal Code
60044
Country
Italy
Facility Name
Ospedale Civile di Senigallia
City
Senigallia
State/Province
Ancona
ZIP/Postal Code
60019
Country
Italy
Facility Name
dell'Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I
City
Torrette di Ancona
State/Province
Ancona
ZIP/Postal Code
60020
Country
Italy
Facility Name
Presidio Ospedaliero di Ariano Irpino
City
Ariano Irpino
State/Province
Avellino
ZIP/Postal Code
83031
Country
Italy
Facility Name
A.O. "Ospedale Treviglio-Caravaggio"
City
Treviglio
State/Province
Bergamo
ZIP/Postal Code
24047
Country
Italy
Facility Name
P.O. di Monserrato - Policlinico Universitario di Cagliari
City
Monserrato
State/Province
Cagliari
ZIP/Postal Code
09042
Country
Italy
Facility Name
P.O. di Monserrato
City
Monserrato
State/Province
Cagliari
ZIP/Postal Code
09042
Country
Italy
Facility Name
Ospedale Civile "Ferrari"
City
Castrovillari
State/Province
Cosenza
ZIP/Postal Code
87012
Country
Italy
Facility Name
Presidio Ospedaliero di Lamezia Terme
City
Lamezia Terme
State/Province
Cosenza
ZIP/Postal Code
88046
Country
Italy
Facility Name
Ospedale "San Francesco" di Paola
City
Paola
State/Province
Cosenza
ZIP/Postal Code
87027
Country
Italy
Facility Name
P.O. S. Lazzaro
City
Alba
State/Province
Cuneo
ZIP/Postal Code
12051
Country
Italy
Facility Name
Ospedale Santa Maria Annunziata
City
Antella
State/Province
Firenze
ZIP/Postal Code
50011
Country
Italy
Facility Name
Ospedale "San Giuseppe"
City
Empoli
State/Province
Firenze
ZIP/Postal Code
50053
Country
Italy
Facility Name
Ospedale Civico di Carrara
City
Carrara
State/Province
Massa Carrara
ZIP/Postal Code
54033
Country
Italy
Facility Name
A.O "San Gerardo" di Monza
City
Monza
State/Province
Milano
ZIP/Postal Code
20052
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Ospedale IRCCS Policlinico di San Donato
City
San Donato Milanese
State/Province
Milano
ZIP/Postal Code
20097
Country
Italy
Facility Name
Presidio Ospedaliero "Serbelloni"di Gorgonzola
City
Vizzolo Predabissi
State/Province
Milano
ZIP/Postal Code
20070
Country
Italy
Facility Name
Ospedale "B.Ramazzini"
City
Carpi
State/Province
Modena
ZIP/Postal Code
41012
Country
Italy
Facility Name
Presidio Ospedaliero "Santa Maria delle Grazie"
City
Pozzuoli
State/Province
Napoli
ZIP/Postal Code
80087
Country
Italy
Facility Name
Ospedale Civile di Este
City
Este
State/Province
Padova
ZIP/Postal Code
35043
Country
Italy
Facility Name
Ospedale di Città di Castello - ASL 1 Umbria
City
Città di Castello
State/Province
Perugia
ZIP/Postal Code
06012
Country
Italy
Facility Name
Ospedale di Marsciano - Servizio Oncologico
City
Marsciano
State/Province
Perugia
ZIP/Postal Code
06055
Country
Italy
Facility Name
Ospedale "Santa Croce"
City
Fano
State/Province
Pesaro
ZIP/Postal Code
61032
Country
Italy
Facility Name
Ospedale Civile "San Massimo"
City
Penne
State/Province
Pesaro
ZIP/Postal Code
65017
Country
Italy
Facility Name
Centro di Riferimento Oncologico - INT
City
Aviano
State/Province
Pordenone
ZIP/Postal Code
33081
Country
Italy
Facility Name
Centro di Riferimento Oncologico di Basilicata
City
Rionero in Vulture
State/Province
Potenza
ZIP/Postal Code
85028
Country
Italy
Facility Name
P.O. di Faenza
City
Faenza
State/Province
Ravenna
ZIP/Postal Code
48018
Country
Italy
Facility Name
P.O. Umberto I di Lugo
City
Lugo
State/Province
Ravenna
ZIP/Postal Code
48022
Country
Italy
Facility Name
Ospedale Civile di Siderno
City
Siderno
State/Province
Reggio Calabria
ZIP/Postal Code
89048
Country
Italy
Facility Name
Ospedale "San Luca"
City
Vallo della Lucania
State/Province
Salerno
ZIP/Postal Code
84078
Country
Italy
Facility Name
Istituto per la Ricerca e la Cura del Cancro di Candiolo
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Facility Name
Ospedale Civile di Latisana
City
Latisana
State/Province
Udine
ZIP/Postal Code
33053
Country
Italy
Facility Name
Azienda Ospedaliera S. Maria
City
Terni
State/Province
Umbria
ZIP/Postal Code
05100
Country
Italy
Facility Name
Presidio Ospedaliero di Saronno - A.O. "Ospedale di Circolo di Busto Arsizio"
City
Saronno
State/Province
Varallo
ZIP/Postal Code
21047
Country
Italy
Facility Name
A.O. "Ospedale di Circolo di Busto Arsizio"
City
Busto Arsizio
State/Province
Varese
ZIP/Postal Code
21052
Country
Italy
Facility Name
Ospedale di Legnago
City
Legnago
State/Province
Verona
ZIP/Postal Code
37045
Country
Italy
Facility Name
Ospedale di Montecchio Maggiore
City
Montecchio Maggiore
State/Province
Vicenza
ZIP/Postal Code
36075
Country
Italy
Facility Name
Ospedale. S. Donato
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
A.O. "G. Rummo"
City
Benevento
ZIP/Postal Code
82100
Country
Italy
Facility Name
Ospedali "Riuniti"
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Facility Name
Ospedale degli Infermi di Biella
City
Biella
ZIP/Postal Code
13900
Country
Italy
Facility Name
Ospedale Maggiore-Bellaria
City
Bologna
ZIP/Postal Code
40133
Country
Italy
Facility Name
A.O.Policlinico "S.Orsola-Malpighi"
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ospedale Sant'Orsola - Fatebenefratelli
City
Brescia
ZIP/Postal Code
25122
Country
Italy
Facility Name
Casa di Cura Poliambulanza di Brescia
City
Brescia
ZIP/Postal Code
25124
Country
Italy
Facility Name
Spedali Civili
City
Brescia
ZIP/Postal Code
25125
Country
Italy
Facility Name
P.O. Vittorio Emanuele
City
Catania
ZIP/Postal Code
95100
Country
Italy
Facility Name
Ospedale Garibaldi in Nesima
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
A.O. Sant'Anna
City
Como
ZIP/Postal Code
22100
Country
Italy
Facility Name
Ospedale "Valduce"
City
Como
ZIP/Postal Code
22100
Country
Italy
Facility Name
A.O. "Ospedale Maggiore" di Crema
City
Crema
ZIP/Postal Code
26013
Country
Italy
Facility Name
Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
A.O. "S.Croce e Carle"
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria "S.Anna"
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Facility Name
A.O. Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
A.O. "G.B.Morgagni-L.Pierantoni
City
Forli
ZIP/Postal Code
47100
Country
Italy
Facility Name
E.O. Ospedali Galliera di Genova
City
Genova
ZIP/Postal Code
16128
Country
Italy
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
P.O. "A.Manzoni" di Lecco
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Azienda USL 6 - P.O. Livorno
City
Livorno
ZIP/Postal Code
57100
Country
Italy
Facility Name
Ospedale Civile di Casalpusterlengo
City
Lodi
ZIP/Postal Code
26900
Country
Italy
Facility Name
Ospedale "Campo di Marte"
City
Lucca
ZIP/Postal Code
55100
Country
Italy
Facility Name
A.O. "C.Poma"
City
Mantova
ZIP/Postal Code
46100
Country
Italy
Facility Name
Istituto Scientifico Universitario San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Istituto Nazionale per la cura dei tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliera "Ospedale San Carlo Borromeo"
City
Milano
ZIP/Postal Code
20153
Country
Italy
Facility Name
Azienda Ospedaliera "Luigi Sacco" Polo Universitario
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Azienda Ospedaliera "San Paolo" Polo Universitario
City
Milano
Country
Italy
Facility Name
A.O. "D.Cotugno"
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
A.O.R.N. "Antonio Cardarelli"
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria "Federico II"
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Pascale"
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera "Maggiore della Carità"
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Ospedali "Civico e Benfratelli - G. Di Cristina - Maurizio Ascoli"
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"di Palermo
City
Palermo
ZIP/Postal Code
90129
Country
Italy
Facility Name
Azienda Ospedaliera di Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
A.O."Ospedale S.Salvatore"
City
Pesaro
ZIP/Postal Code
61100
Country
Italy
Facility Name
Ospedale Civile dello "Spirito Santo"
City
Pescara
ZIP/Postal Code
65100
Country
Italy
Facility Name
Ospedale Civile di Piacenza
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
Facility Name
Azienda Ospedaliera-Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
A.O. "Santa Maria degli Angeli"
City
Pordenone
ZIP/Postal Code
33170
Country
Italy
Facility Name
Ospedale "San Carlo"di Potenza
City
Potenza
ZIP/Postal Code
85100
Country
Italy
Facility Name
Ospedale "Misericordia e Dolce"
City
Prato
ZIP/Postal Code
59100
Country
Italy
Facility Name
P.O. di Ravenna - Azienda Unità Sanitaria Locale di Ravenna
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Facility Name
A.O. "Bianchi-Melacrino-Morelli"
City
Reggio Calabria
ZIP/Postal Code
89100
Country
Italy
Facility Name
Arcispedale Santa Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Ospedale "Infermi"
City
Rimini
ZIP/Postal Code
47900
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria "Policlinico Tor Vergata"
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Policlinico Umberto I
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Ospedale Fatebenefratelli "San Giovanni Calibita"
City
Roma
ZIP/Postal Code
00186
Country
Italy
Facility Name
Istituto Nazionale di Riposo e Cura per Anziani
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Istituto Dermopatico dell'Immacolata - IRCCS
City
Roma
ZIP/Postal Code
MD
Country
Italy
Facility Name
Azienda Unità Sanitaria Locale n°1 Sassari
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Ospedale Civile di Sassari
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
A.O. della Valtellina e della Valchiavenna
City
Sondrio
ZIP/Postal Code
23100
Country
Italy
Facility Name
Ospedale San Giovanni Battista di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
A.O."Ospedale di Circolo e Fondazione Macchi"
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
A.O. Istituti Ospitalieri di Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
24728035
Citation
Bajetta E, Floriani I, Di Bartolomeo M, Labianca R, Falcone A, Di Costanzo F, Comella G, Amadori D, Pinto C, Carlomagno C, Nitti D, Daniele B, Mini E, Poli D, Santoro A, Mosconi S, Casaretti R, Boni C, Pinotti G, Bidoli P, Landi L, Rosati G, Ravaioli A, Cantore M, Di Fabio F, Aitini E, Marchet A; ITACA-S (Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach Trial) Study Group. Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer. Ann Oncol. 2014 Jul;25(7):1373-1378. doi: 10.1093/annonc/mdu146. Epub 2014 Apr 12.
Results Reference
derived

Learn more about this trial

Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach

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