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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01640782
Other study ID # ITACA-S
Secondary ID
Status Completed
Phase Phase 3
First received July 9, 2012
Last updated July 17, 2014
Start date February 2005
Est. completion date January 2013

Study information

Verified date December 2013
Source Mario Negri Institute for Pharmacological Research
Contact n/a
Is FDA regulated No
Health authority Italy: The Italian Medicines Agency
Study type Interventional

Clinical 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 eligible for this study.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1100
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Irinotecan, Leucovorin, 5-Fluorouracil, Docetaxel, Cisplatin
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-Fluorouracil
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.

Locations

Country Name City State
Italy P.O. S. Lazzaro Alba Cuneo
Italy Ospedale Santa Maria Annunziata Antella Firenze
Italy Ospedale. S. Donato Arezzo
Italy Presidio Ospedaliero di Ariano Irpino Ariano Irpino Avellino
Italy Centro di Riferimento Oncologico - INT Aviano Pordenone
Italy A.O. "G. Rummo" Benevento
Italy Ospedali "Riuniti" Bergamo
Italy Ospedale degli Infermi di Biella Biella
Italy A.O.Policlinico "S.Orsola-Malpighi" Bologna
Italy Ospedale Maggiore-Bellaria Bologna
Italy Casa di Cura Poliambulanza di Brescia Brescia
Italy Ospedale Sant'Orsola - Fatebenefratelli Brescia
Italy Spedali Civili Brescia
Italy A.O. "Ospedale di Circolo di Busto Arsizio" Busto Arsizio Varese
Italy Istituto per la Ricerca e la Cura del Cancro di Candiolo Candiolo Torino
Italy Ospedale "B.Ramazzini" Carpi Modena
Italy Ospedale Civico di Carrara Carrara Massa Carrara
Italy Ospedale Civile "Ferrari" Castrovillari Cosenza
Italy Ospedale Garibaldi in Nesima Catania
Italy P.O. Vittorio Emanuele Catania
Italy Ospedale di Città di Castello - ASL 1 Umbria Città di Castello Perugia
Italy A.O. Sant'Anna Como
Italy Ospedale "Valduce" Como
Italy A.O. "Ospedale Maggiore" di Crema Crema
Italy Azienda Ospedaliera "Istituti Ospitalieri" di Cremona Cremona
Italy A.O. "S.Croce e Carle" Cuneo
Italy Ospedale "San Giuseppe" Empoli Firenze
Italy Ospedale Civile di Este Este Padova
Italy ASL 6 - Fabriano Fabriano Ancona
Italy P.O. di Faenza Faenza Ravenna
Italy Ospedale "Santa Croce" Fano Pesaro
Italy Azienda Ospedaliera Universitaria "S.Anna" Ferrara
Italy A.O. Universitaria Careggi Firenze
Italy A.O. "G.B.Morgagni-L.Pierantoni Forli
Italy E.O. Ospedali Galliera di Genova Genova
Italy Istituto Nazionale per la Ricerca sul Cancro Genova
Italy Presidio Ospedaliero di Lamezia Terme Lamezia Terme Cosenza
Italy Ospedale Civile di Latisana Latisana Udine
Italy P.O. "A.Manzoni" di Lecco Lecco
Italy Ospedale di Legnago Legnago Verona
Italy Azienda USL 6 - P.O. Livorno Livorno
Italy Ospedale Civile di Casalpusterlengo Lodi
Italy Ospedale "Campo di Marte" Lucca
Italy P.O. Umberto I di Lugo Lugo Ravenna
Italy A.O. "C.Poma" Mantova
Italy Ospedale di Marsciano - Servizio Oncologico Marsciano Perugia
Italy Azienda Ospedaliera "Luigi Sacco" Polo Universitario Milano
Italy Azienda Ospedaliera "Ospedale San Carlo Borromeo" Milano
Italy Azienda Ospedaliera "San Paolo" Polo Universitario Milano
Italy Istituto Europeo di Oncologia Milano
Italy Istituto Nazionale per la cura dei tumori Milano
Italy Istituto Scientifico Universitario San Raffaele Milano
Italy P.O. di Monserrato Monserrato Cagliari
Italy P.O. di Monserrato - Policlinico Universitario di Cagliari Monserrato Cagliari
Italy Ospedale di Montecchio Maggiore Montecchio Maggiore Vicenza
Italy A.O "San Gerardo" di Monza Monza Milano
Italy A.O. "D.Cotugno" Napoli
Italy A.O.R.N. "Antonio Cardarelli" Napoli
Italy Azienda Ospedaliera Universitaria "Federico II" Napoli
Italy Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Pascale" Napoli
Italy Azienda Ospedaliera "Maggiore della Carità" Novara
Italy Azienda Ospedaliera di Padova Padova
Italy Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"di Palermo Palermo
Italy Ospedali "Civico e Benfratelli - G. Di Cristina - Maurizio Ascoli" Palermo
Italy Ospedale "San Francesco" di Paola Paola Cosenza
Italy Azienda Ospedaliera di Parma Parma
Italy Ospedale Civile "San Massimo" Penne Pesaro
Italy A.O."Ospedale S.Salvatore" Pesaro
Italy Ospedale Civile dello "Spirito Santo" Pescara
Italy Ospedale Civile di Piacenza Piacenza
Italy Azienda Ospedaliera-Universitaria Pisana Pisa
Italy A.O. "Santa Maria degli Angeli" Pordenone
Italy Ospedale "San Carlo"di Potenza Potenza
Italy Presidio Ospedaliero "Santa Maria delle Grazie" Pozzuoli Napoli
Italy Ospedale "Misericordia e Dolce" Prato
Italy P.O. di Ravenna - Azienda Unità Sanitaria Locale di Ravenna Ravenna
Italy A.O. "Bianchi-Melacrino-Morelli" Reggio Calabria
Italy Arcispedale Santa Maria Nuova Reggio Emilia
Italy Ospedale "Infermi" Rimini
Italy Centro di Riferimento Oncologico di Basilicata Rionero in Vulture Potenza
Italy Azienda Ospedaliera Universitaria "Policlinico Tor Vergata" Roma
Italy Istituto Dermopatico dell'Immacolata - IRCCS Roma
Italy Istituto Nazionale di Riposo e Cura per Anziani Roma
Italy Ospedale Fatebenefratelli "San Giovanni Calibita" Roma
Italy Policlinico Umberto I Roma
Italy Istituto Clinico Humanitas Rozzano Milano
Italy Ospedale IRCCS Policlinico di San Donato San Donato Milanese Milano
Italy Presidio Ospedaliero di Saronno - A.O. "Ospedale di Circolo di Busto Arsizio" Saronno Varallo
Italy Azienda Unità Sanitaria Locale n°1 Sassari Sassari
Italy Ospedale Civile di Sassari Sassari
Italy Ospedale Civile di Senigallia Senigallia Ancona
Italy Ospedale Civile di Siderno Siderno Reggio Calabria
Italy A.O. della Valtellina e della Valchiavenna Sondrio
Italy Azienda Ospedaliera S. Maria Terni Umbria
Italy Ospedale San Giovanni Battista di Torino Torino
Italy dell'Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I Torrette di Ancona Ancona
Italy A.O. "Ospedale Treviglio-Caravaggio" Treviglio Bergamo
Italy Ospedale "San Luca" Vallo della Lucania Salerno
Italy A.O."Ospedale di Circolo e Fondazione Macchi" Varese
Italy A.O. Istituti Ospitalieri di Verona Verona
Italy Presidio Ospedaliero "Serbelloni"di Gorgonzola Vizzolo Predabissi Milano

Sponsors (9)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 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 Yes
Secondary Toxicity, graded according to the NCI-CTG Expanded Common Toxicity Criteria 3 years Yes
Secondary Adverse events 3 years Yes
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