Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach
ITACA-S
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
1 other identifier
interventional
1,100
1 country
101
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2005
Longer than P75 for phase_3
101 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 9, 2012
CompletedFirst Posted
Study publicly available on registry
July 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJuly 18, 2014
December 1, 2013
7.9 years
July 9, 2012
July 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 years
Secondary Outcomes (3)
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
3 years
Toxicity, graded according to the NCI-CTG Expanded Common Toxicity Criteria
3 years
Adverse events
3 years
Study Arms (2)
Sequential regimen
EXPERIMENTALSequential treatment with CPT-11 plus Fluorouracil (FU), folinic acid (LV) and Docetaxel (TXT) plus Cisplatin (CDDP)
De Gramont regimen
ACTIVE COMPARATORFluorouracil (5-FU), folinic acid (LV)
Interventions
* 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.
* 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mario Negri Institute for Pharmacological Researchlead
- Aventis Pharmaceuticalscollaborator
- Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerentecollaborator
- Gruppo Oncologico Italiano di Ricerca Clinicacollaborator
- Gruppo Oncologico del Nord-Ovestcollaborator
- Italian Trial in Medical Oncologycollaborator
- Southern Italy Cooperative Oncology Groupcollaborator
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCScollaborator
- Oncotechcollaborator
Study Sites (101)
ASL 6 - Fabriano
Fabriano, Ancona, 60044, Italy
Ospedale Civile di Senigallia
Senigallia, Ancona, 60019, Italy
dell'Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I
Torrette Di Ancona, Ancona, 60020, Italy
Ospedale. S. Donato
Arezzo, Arezzo, 52100, Italy
Presidio Ospedaliero di Ariano Irpino
Ariano Irpino, Avellino, 83031, Italy
A.O. "G. Rummo"
Benevento, Benevento, 82100, Italy
Ospedali "Riuniti"
Bergamo, Bergamo, 24128, Italy
A.O. "Ospedale Treviglio-Caravaggio"
Treviglio, Bergamo, 24047, Italy
Ospedale degli Infermi di Biella
Biella, Biella, 13900, Italy
Ospedale Maggiore-Bellaria
Bologna, Bologna, 40133, Italy
A.O.Policlinico "S.Orsola-Malpighi"
Bologna, Bologna, 40138, Italy
Ospedale Sant'Orsola - Fatebenefratelli
Brescia, Brescia, 25122, Italy
Casa di Cura Poliambulanza di Brescia
Brescia, Brescia, 25124, Italy
Spedali Civili
Brescia, Brescia, 25125, Italy
P.O. di Monserrato - Policlinico Universitario di Cagliari
Monserrato, Cagliari, 09042, Italy
P.O. di Monserrato
Monserrato, Cagliari, 09042, Italy
P.O. Vittorio Emanuele
Catania, Catania, 95100, Italy
Ospedale Garibaldi in Nesima
Catania, Catania, 95123, Italy
A.O. Sant'Anna
Como, Como, 22100, Italy
Ospedale "Valduce"
Como, Como, 22100, Italy
Ospedale Civile "Ferrari"
Castrovillari, Cosenza, 87012, Italy
Presidio Ospedaliero di Lamezia Terme
Lamezia Terme, Cosenza, 88046, Italy
Ospedale "San Francesco" di Paola
Paola, Cosenza, 87027, Italy
A.O. "Ospedale Maggiore" di Crema
Crema, Crema, 26013, Italy
Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
Cremona, Cremona, 26100, Italy
P.O. S. Lazzaro
Alba, Cuneo, 12051, Italy
A.O. "S.Croce e Carle"
Cuneo, Cuneo, 12100, Italy
Azienda Ospedaliera Universitaria "S.Anna"
Ferrara, Ferrara, 44100, Italy
Ospedale Santa Maria Annunziata
Antella, Firenze, 50011, Italy
Ospedale "San Giuseppe"
Empoli, Firenze, 50053, Italy
A.O. Universitaria Careggi
Florence, Firenze, 50134, Italy
A.O. "G.B.Morgagni-L.Pierantoni
Forlì, Forli, 47100, Italy
E.O. Ospedali Galliera di Genova
Genova, Genova, 16128, Italy
Istituto Nazionale per la Ricerca sul Cancro
Genova, Genova, 16132, Italy
P.O. "A.Manzoni" di Lecco
Lecco, Lecco, 23900, Italy
Azienda USL 6 - P.O. Livorno
Livorno, Livorno, 57100, Italy
Ospedale Civile di Casalpusterlengo
Lodi, Lodi, 26900, Italy
Ospedale "Campo di Marte"
Lucca, Lucca, 55100, Italy
A.O. "C.Poma"
Mantova, Mantova, 46100, Italy
Ospedale Civico di Carrara
Carrara, Massa Carrara, 54033, Italy
Istituto Scientifico Universitario San Raffaele
Milan, Milano, 20132, Italy
Istituto Nazionale per la cura dei tumori
Milan, Milano, 20133, Italy
Istituto Europeo di Oncologia
Milan, Milano, 20141, Italy
Azienda Ospedaliera "Ospedale San Carlo Borromeo"
Milan, Milano, 20153, Italy
Azienda Ospedaliera "Luigi Sacco" Polo Universitario
Milan, Milano, 20157, Italy
Azienda Ospedaliera "San Paolo" Polo Universitario
Milan, Milano, Italy
A.O "San Gerardo" di Monza
Monza, Milano, 20052, Italy
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
Ospedale IRCCS Policlinico di San Donato
San Donato Milanese, Milano, 20097, Italy
Presidio Ospedaliero "Serbelloni"di Gorgonzola
Vizzolo Predabissi, Milano, 20070, Italy
Ospedale "B.Ramazzini"
Carpi, Modena, 41012, Italy
A.O. "D.Cotugno"
Napoli, Napoli, 80131, Italy
A.O.R.N. "Antonio Cardarelli"
Napoli, Napoli, 80131, Italy
Azienda Ospedaliera Universitaria "Federico II"
Napoli, Napoli, 80131, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Pascale"
Napoli, Napoli, 80131, Italy
Presidio Ospedaliero "Santa Maria delle Grazie"
Pozzuoli, Napoli, 80087, Italy
Azienda Ospedaliera "Maggiore della Carità"
Novara, Novara, 28100, Italy
Ospedale Civile di Este
Este, Padova, 35043, Italy
Azienda Ospedaliera di Padova
Padua, Padova, 35128, Italy
Ospedali "Civico e Benfratelli - G. Di Cristina - Maurizio Ascoli"
Palermo, Palermo, 90127, Italy
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"di Palermo
Palermo, Palermo, 90129, Italy
Azienda Ospedaliera di Parma
Parma, Parma, 43100, Italy
Ospedale di Città di Castello - ASL 1 Umbria
Città di Castello, Perugia, 06012, Italy
Ospedale di Marsciano - Servizio Oncologico
Marsciano, Perugia, 06055, Italy
Ospedale "Santa Croce"
Fano, Pesaro, 61032, Italy
Ospedale Civile "San Massimo"
Penne, Pesaro, 65017, Italy
A.O."Ospedale S.Salvatore"
Pesaro, Pesaro, 61100, Italy
Ospedale Civile dello "Spirito Santo"
Pescara, Pescara, 65100, Italy
Ospedale Civile di Piacenza
Piacenza, Piacenza, 29100, Italy
Azienda Ospedaliera-Universitaria Pisana
Pisa, Pisa, 56126, Italy
Centro di Riferimento Oncologico - INT
Aviano, Pordenone, 33081, Italy
A.O. "Santa Maria degli Angeli"
Pordenone, Pordenone, 33170, Italy
Ospedale "San Carlo"di Potenza
Potenza, Potenza, 85100, Italy
Centro di Riferimento Oncologico di Basilicata
Rionero in Vulture, Potenza, 85028, Italy
Ospedale "Misericordia e Dolce"
Prato, Prato, 59100, Italy
P.O. di Faenza
Faenza, Ravenna, 48018, Italy
P.O. Umberto I di Lugo
Lugo, Ravenna, 48022, Italy
P.O. di Ravenna - Azienda Unità Sanitaria Locale di Ravenna
Ravenna, Ravenna, 48100, Italy
A.O. "Bianchi-Melacrino-Morelli"
Reggio Calabria, Reggio Calabria, 89100, Italy
Ospedale Civile di Siderno
Siderno, Reggio Calabria, 89048, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, Reggio Emilia, 42100, Italy
Ospedale "Infermi"
Rimini, Rimini, 47900, Italy
Azienda Ospedaliera Universitaria "Policlinico Tor Vergata"
Roma, Roma, 00133, Italy
Policlinico Umberto I
Roma, Roma, 00161, Italy
Ospedale Fatebenefratelli "San Giovanni Calibita"
Roma, Roma, 00186, Italy
Istituto Nazionale di Riposo e Cura per Anziani
Roma, Roma, 00189, Italy
Istituto Dermopatico dell'Immacolata - IRCCS
Roma, Roma, MD, Italy
Ospedale "San Luca"
Vallo della Lucania, Salerno, 84078, Italy
Azienda Unità Sanitaria Locale n°1 Sassari
Sassari, Sassari, 07100, Italy
Ospedale Civile di Sassari
Sassari, Sassari, 07100, Italy
A.O. della Valtellina e della Valchiavenna
Sondrio, Sondrio, 23100, Italy
Istituto per la Ricerca e la Cura del Cancro di Candiolo
Candiolo, Torino, 10060, Italy
Ospedale San Giovanni Battista di Torino
Torino, Torino, 10126, Italy
Ospedale Civile di Latisana
Latisana, Udine, 33053, Italy
Azienda Ospedaliera S. Maria
Terni, Umbria, 05100, Italy
Presidio Ospedaliero di Saronno - A.O. "Ospedale di Circolo di Busto Arsizio"
Saronno, Varallo, 21047, Italy
A.O. "Ospedale di Circolo di Busto Arsizio"
Busto Arsizio, Varese, 21052, Italy
A.O."Ospedale di Circolo e Fondazione Macchi"
Varese, Varese, 21100, Italy
Ospedale di Legnago
Legnago, Verona, 37045, Italy
A.O. Istituti Ospitalieri di Verona
Verona, Verona, 37126, Italy
Ospedale di Montecchio Maggiore
Montecchio Maggiore, Vicenza, 36075, Italy
Related Publications (1)
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.
PMID: 24728035DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emilio Bajetta, MD
Istituto Nazionale Per lo Studio e la Cura dei Tumori Milano
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2012
First Posted
July 16, 2012
Study Start
February 1, 2005
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
July 18, 2014
Record last verified: 2013-12