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Adenocarcinoma of the StomachPhase 3ITACA-SNCT01640782

Intergroup Trial of Adjuvant Chemotherapy in Adenocarcinoma of the Stomach

A Phase 3 study testing Irinotecan, Leucovorin, 5-Fluorouracil, Docetaxel, Cisplatin and Leucovorin, 5-Fluorouracil in people with Adenocarcinoma of the Stomach and Adenocarcinoma of the Gastroesophageal Junction, run by Mario Negri Institute for Pharmacological Research at 101 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Irinotecan, Leucovorin, 5-Fluorouracil, Docetaxel, Cisplatin and Leucovorin, 5-Fluorouracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,100 participants
Where
101 sitesItaly
Study dates
Feb 2005to Jan 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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,
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  • 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

Trial locations and contacts

101 sites in 1 country.

101 sites in 1 country

Italy101 sites

  • P.O. S. Lazzaro

    Alba, Cuneo, 12051

  • Ospedale Santa Maria Annunziata

    Antella, Firenze, 50011

  • Ospedale. S. Donato

    Arezzo, Arezzo, 52100

  • Presidio Ospedaliero di Ariano Irpino

    Ariano Irpino, Avellino, 83031

  • Centro di Riferimento Oncologico - INT

    Aviano, Pordenone, 33081

  • A.O. "G. Rummo"

    Benevento, Benevento, 82100

  • Ospedali "Riuniti"

    Bergamo, Bergamo, 24128

  • Ospedale degli Infermi di Biella

    Biella, Biella, 13900

  • Ospedale Maggiore-Bellaria

    Bologna, Bologna, 40133

  • A.O.Policlinico "S.Orsola-Malpighi"

    Bologna, Bologna, 40138

  • Ospedale Sant'Orsola - Fatebenefratelli

    Brescia, Brescia, 25122

  • Casa di Cura Poliambulanza di Brescia

    Brescia, Brescia, 25124

  • Spedali Civili

    Brescia, Brescia, 25125

  • A.O. "Ospedale di Circolo di Busto Arsizio"

    Busto Arsizio, Varese, 21052

  • Istituto per la Ricerca e la Cura del Cancro di Candiolo

    Candiolo, Torino, 10060

  • Ospedale "B.Ramazzini"

    Carpi, Modena, 41012

  • Ospedale Civico di Carrara

    Carrara, Massa Carrara, 54033

  • Ospedale Civile "Ferrari"

    Castrovillari, Cosenza, 87012

  • P.O. Vittorio Emanuele

    Catania, Catania, 95100

  • Ospedale Garibaldi in Nesima

    Catania, Catania, 95123

  • Ospedale di Città di Castello - ASL 1 Umbria

    Città di Castello, Perugia, 06012

  • A.O. Sant'Anna

    Como, Como, 22100

  • Ospedale "Valduce"

    Como, Como, 22100

  • A.O. "Ospedale Maggiore" di Crema

    Crema, Crema, 26013

  • Azienda Ospedaliera "Istituti Ospitalieri" di Cremona

    Cremona, Cremona, 26100

  • A.O. "S.Croce e Carle"

    Cuneo, Cuneo, 12100

  • Ospedale "San Giuseppe"

    Empoli, Firenze, 50053

  • Ospedale Civile di Este

    Este, Padova, 35043

  • ASL 6 - Fabriano

    Fabriano, Ancona, 60044

  • P.O. di Faenza

    Faenza, Ravenna, 48018

  • Ospedale "Santa Croce"

    Fano, Pesaro, 61032

  • Azienda Ospedaliera Universitaria "S.Anna"

    Ferrara, Ferrara, 44100

  • A.O. Universitaria Careggi

    Florence, Firenze, 50134

  • A.O. "G.B.Morgagni-L.Pierantoni

    Forlì, Forli, 47100

  • E.O. Ospedali Galliera di Genova

    Genova, Genova, 16128

  • Istituto Nazionale per la Ricerca sul Cancro

    Genova, Genova, 16132

  • Presidio Ospedaliero di Lamezia Terme

    Lamezia Terme, Cosenza, 88046

  • Ospedale Civile di Latisana

    Latisana, Udine, 33053

  • P.O. "A.Manzoni" di Lecco

    Lecco, Lecco, 23900

  • Ospedale di Legnago

    Legnago, Verona, 37045

  • Azienda USL 6 - P.O. Livorno

    Livorno, Livorno, 57100

  • Ospedale Civile di Casalpusterlengo

    Lodi, Lodi, 26900

  • Ospedale "Campo di Marte"

    Lucca, Lucca, 55100

  • P.O. Umberto I di Lugo

    Lugo, Ravenna, 48022

  • A.O. "C.Poma"

    Mantua, Mantova, 46100

  • Ospedale di Marsciano - Servizio Oncologico

    Marsciano, Perugia, 06055

  • Istituto Scientifico Universitario San Raffaele

    Milan, Milano, 20132

  • Istituto Nazionale per la cura dei tumori

    Milan, Milano, 20133

  • Istituto Europeo di Oncologia

    Milan, Milano, 20141

  • Azienda Ospedaliera "Ospedale San Carlo Borromeo"

    Milan, Milano, 20153

  • Azienda Ospedaliera "Luigi Sacco" Polo Universitario

    Milan, Milano, 20157

  • Azienda Ospedaliera "San Paolo" Polo Universitario

    Milan, Milano

  • P.O. di Monserrato - Policlinico Universitario di Cagliari

    Monserrato, Cagliari, 09042

  • P.O. di Monserrato

    Monserrato, Cagliari, 09042

  • Ospedale di Montecchio Maggiore

    Montecchio Maggiore, Vicenza, 36075

  • A.O "San Gerardo" di Monza

    Monza, Milano, 20052

  • A.O. "D.Cotugno"

    Naples, Napoli, 80131

  • A.O.R.N. "Antonio Cardarelli"

    Naples, Napoli, 80131

  • Azienda Ospedaliera Universitaria "Federico II"

    Naples, Napoli, 80131

  • Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Pascale"

    Naples, Napoli, 80131

  • Azienda Ospedaliera "Maggiore della Carità"

    Novara, Novara, 28100

  • Azienda Ospedaliera di Padova

    Padova, Padova, 35128

  • Ospedali "Civico e Benfratelli - G. Di Cristina - Maurizio Ascoli"

    Palermo, Palermo, 90127

  • Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"di Palermo

    Palermo, Palermo, 90129

  • Ospedale "San Francesco" di Paola

    Paola, Cosenza, 87027

  • Azienda Ospedaliera di Parma

    Parma, Parma, 43100

  • Ospedale Civile "San Massimo"

    Penne, Pesaro, 65017

  • A.O."Ospedale S.Salvatore"

    Pesaro, Pesaro, 61100

  • Ospedale Civile dello "Spirito Santo"

    Pescara, Pescara, 65100

  • Ospedale Civile di Piacenza

    Piacenza, Piacenza, 29100

  • Azienda Ospedaliera-Universitaria Pisana

    Pisa, Pisa, 56126

  • A.O. "Santa Maria degli Angeli"

    Pordenone, Pordenone, 33170

  • Ospedale "San Carlo"di Potenza

    Potenza, Potenza, 85100

  • Presidio Ospedaliero "Santa Maria delle Grazie"

    Pozzuoli, Napoli, 80087

  • Ospedale "Misericordia e Dolce"

    Prato, Prato, 59100

  • P.O. di Ravenna - Azienda Unità Sanitaria Locale di Ravenna

    Ravenna, Ravenna, 48100

  • A.O. "Bianchi-Melacrino-Morelli"

    Reggio Calabria, Reggio Calabria, 89100

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, Reggio Emilia, 42100

  • Ospedale "Infermi"

    Rimini, Rimini, 47900

  • Centro di Riferimento Oncologico di Basilicata

    Rionero in Vulture, Potenza, 85028

  • Azienda Ospedaliera Universitaria "Policlinico Tor Vergata"

    Roma, Roma, 00133

  • Policlinico Umberto I

    Roma, Roma, 00161

  • Ospedale Fatebenefratelli "San Giovanni Calibita"

    Roma, Roma, 00186

  • Istituto Nazionale di Riposo e Cura per Anziani

    Roma, Roma, 00189

  • Istituto Dermopatico dell'Immacolata - IRCCS

    Roma, Roma, MD

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • Ospedale IRCCS Policlinico di San Donato

    San Donato Milanese, Milano, 20097

  • Presidio Ospedaliero di Saronno - A.O. "Ospedale di Circolo di Busto Arsizio"

    Saronno, Varallo, 21047

  • Azienda Unità Sanitaria Locale n°1 Sassari

    Sassari, Sassari, 07100

  • Ospedale Civile di Sassari

    Sassari, Sassari, 07100

  • Ospedale Civile di Senigallia

    Senigallia, Ancona, 60019

  • Ospedale Civile di Siderno

    Siderno, Reggio Calabria, 89048

  • A.O. della Valtellina e della Valchiavenna

    Sondrio, Sondrio, 23100

  • Azienda Ospedaliera S. Maria

    Terni, Umbria, 05100

  • Ospedale San Giovanni Battista di Torino

    Torino, Torino, 10126

  • dell'Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I

    Torrette Di Ancona, Ancona, 60020

  • A.O. "Ospedale Treviglio-Caravaggio"

    Treviglio, Bergamo, 24047

  • Ospedale "San Luca"

    Vallo della Lucania, Salerno, 84078

  • A.O."Ospedale di Circolo e Fondazione Macchi"

    Varese, Varese, 21100

  • A.O. Istituti Ospitalieri di Verona

    Verona, Verona, 37126

  • Presidio Ospedaliero "Serbelloni"di Gorgonzola

    Vizzolo Predabissi, Milano, 20070

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
Irinotecan, Leucovorin, 5-Fluorouracil, Docetaxel, Cisplatin, Leucovorin, 5-Fluorouracil
Keywords
adenocarcinoma of the stomach, adenocarcinoma of the gastroesophageal junction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Irinotecan, Leucovorin, 5-Fluorouracil, Docetaxel, CisplatinDrug

    • 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, 5-FluorouracilDrug

    • 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.
Study groups in NCT01640782
Study groupRoleWhat they receive
Sequential regimenExperimentalSequential treatment with CPT-11 plus Fluorouracil (FU), folinic acid (LV) and Docetaxel (TXT) plus Cisplatin (CDDP)
Receives: Drug: Irinotecan, Leucovorin, 5-Fluorouracil, Docetaxel, Cisplatin
De Gramont regimenActive comparatorFluorouracil (5-FU), folinic acid (LV)
Receives: Drug: Leucovorin, 5-Fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 years

Secondary outcomes (3)

  1. 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

    Measured: 3 years

  2. Toxicity, graded according to the NCI-CTG Expanded Common Toxicity Criteria

    Measured: 3 years

  3. Adverse events

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2012 (estimated)
  2. Study startFeb 2005
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01640782
Sponsor's protocol ID
ITACA-S
Acronym
ITACA-S
Status last verified
Dec 2013
First submitted
9 Jul 2012
Last updated
18 Jul 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24728035

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Irinotecan, Leucovorin, 5-Fluorouracil, Docetaxel, Cisplatin and Leucovorin, 5-Fluorouracil in people with Adenocarcinoma of the Stomach and Adenocarcinoma of the Gastroesophageal Junction, run by Mario Negri Institute for Pharmacological Research at 101 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01640782, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2014.

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