Low-Tox Vs Eox In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer
Conditions
Locally Advanced Unresectable Gastric Cancer - Metastatic Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Docetaxel Type: Drug
Name: Epirubicin Type: Drug
Name: Oxaliplatin Type: Drug
Name: Capecitabine Type: Drug
Overall Status
Recruiting
Summary
This is a randomized, parallel group, non-blinded phase III trial. Patients with advanced (locoregional or metastatic) gastric cancer not previously treated with chemotherapy for this stage will be randomized in a 1:1 ratio to receive low-TOX (arm A) or EOX (arm B). Randomization will be stratified by performance status (ECOG 0 or 1).
Detailed Description
Although the incidence of the adenocarcinoma of the stomach is slowly decreasing, gastric cancer represents the second worldwide cause of cancer death after lung cancer. In patients with advanced disease, chemotherapy improves survival and quality of life. Combinations of two or three drugs including a platin derivative (cisplatin or oxaliplatin), a fluoropyrimidine (5FU or capecitabine) and an anthracycline (usually epirubicin) have demonstrated superiority compared to single or double agent therapy and are the current standard. As of today there are no published studies comparing anthracycline-based to taxane-based three-drug regimens. The objective of the present study is to compare EOX as evaluated in REAL-2 to the low-TOX regimen consisting of docetaxel, oxaliplatin and capecitabine. Low-TOX is expected to be better tolerated than the original DCF regimen. The study will be performed in the HER2 negative patients.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 69 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Signed written informed consent prior to beginning protocol specific procedures

- Male or female <70 years of age

- Histologically proven diagnosis of adenocarcinoma of the stomach

- HER2 negative tumor or HER2+ tumors not qualifying for herceptin therapy

- Locally advanced (non resectable) or metastatic gastric cancer

- Presence of measurable disease with at least one measurable lesion by means of CT scan or MRI in not previously irradiated area(s) (according to RECIST criteria (version 1.1)

- Life expectancy of >/= 3 months

- ECOG performance status of 0-1 at study entry

- Neutrophils >/= 2.0 x 1000000000/L, platelets >/= 100 x 1000000000/L, and hemoglobin >/= 10 g/dL

- Bilirubin level either normal or
- AST and ALT
- Alkaline phosphatase (ALP) 2.5x ULN and AST and ALT
- Serum creatinine < 1.5 x ULN. In presence border-line values, the calculated creatinine clearance should be >/= 60 mL/min

- Negative pregnancy test (if female in reproductive years)

- Effective contraception prior to study entry and for the duration of the study participation, for both male and female patients of child producing potential

- Able and willing to comply with scheduled visits, therapy plans and laboratory tests required in this protocol

Exclusion Criteria:

- Previous chemotherapy, except adjuvant treatment administered at least 1 year before study entry

- Concurrent chronic systemic immune therapy

- Any investigational agent(s) 4 weeks prior to entry

- Clinically relevant coronary artery disease or a history of a myocardial infarction or a history of hypertension not controlled by therapy within the last 12 months

- Known hypersensitivity to study drugs. Known grade 3 or 4 allergic reaction to any of the components of the treatment

- Known drug abuse/ alcohol abuse

- Acute or subacute intestinal occlusion and any other significant chronic gastrointestinal disease that might interfere with absorption of oral treatment

- History of clinically relevant psychiatric disability precluding informed consent

- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

- Pregnant or breastfeeding women

- Active uncontrolled infection(s)

- Positive for HIV serology and/or viral hepatitis B or C

- Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial)
Locations
ASUR Zona territoriale 6 di Fabriano (AN)
Fabriano, AN, Italy
Status: Recruiting
Contact: Rosa Rita Silva, MD
Istituto Tumori
Bari, BA, Italy
Status: Recruiting
Contact: Nicola Silvestris, MD - +39 080 5555419 - n.silvestris@oncologico.bari.it
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, BG, Italy
Status: Recruiting
Contact: Roberto Labianca, MD - +39 035 2673691 - rlabianca@hpg23.it
A.O. Treviglio-Caravaggio
Treviglio (bg), BG, Italy
Status: Recruiting
Contact: Sandro Barni, MD - +39 036 3424 420
Ospedale degli Infermi
Biella, BI, Italy
Status: Recruiting
Contact: Pietro Sozzi, MD
ASDAA Bolzano
Bolzano, BZ, Italy
Status: Recruiting
Contact: Claudio Graiff, MD - +39 0471 908952
Azienda Ospedaliera Sant'Anna
Como, CO, Italy
Status: Recruiting
Contact: Monica Giordano, MD
Ospedale di Circolo A. Manzoni
Lecco, LC, Italy
Status: Recruiting
Contact: Stefania Dell'Oro, MD - +39 0341 489155
Azienda Ospedaliera Ospedale Maggiore
Lodi, LO, Italy
Status: Recruiting
Contact: Giovanni Ucci, MD
Ospedale Santa Maria Goretti Latina
Latina, LT, Italy
Status: Recruiting
Contact: Enzo Veltri, MD - 07736553840 - e.veltri@ausl.latina.it
A.O. Ospedale Versilia
Camaiore, LU, Italy
Status: Recruiting
Contact: Domenico Amoroso, MD
Azienda Ospedaliera San Gerardo di Monza,
Monza, MB, Italy
Status: Withdrawn
P.O. "San Vincenzo" Taormina
Taormina, ME, Italy
Status: Recruiting
Contact: Francesco Ferraù, MD - +39 0942 579322
Osped. Di Circolo Serbelloni-Gorgonzola
Gorgonzola, MI, Italy
Status: Recruiting
Contact: Maria C. Zavettieri, MD - +39 02 95707 317
Azienda Ospedaliera San Paolo
Milano, MI, Italy
Status: Recruiting
Contact: Daris Ferrari, MD
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milano, MI, Italy
Status: Withdrawn
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, MI, Italy
Status: Recruiting
Contact: Maria Di Bartolomeo, MD - +39 02 23902882 - maria.dibartolomeo@istitutotumori.mi.it
IRCCS Istituto Europeo di Oncologia (IEO)
Milano, MI, Italy
Status: Recruiting
Contact: Nicola Fazio, MD
Ospedale L. Sacco
Milano, MI, Italy
Status: Recruiting
Contact: Elena Piazza, MD
Ospedale di Carpi
Carpi, MO, Italy
Status: Recruiting
Contact: Fabrizio Artioli, MD
AUSL di Piacenza
Piacenza, PC, Italy
Status: Recruiting
Contact: Luigi Cavanna, MD - +39 0523 302697 - l.cavanna@ausl.pc.it
ASL Pescara Ospedale San Massimo
Penne, PE, Italy
Status: Recruiting
Contact: Donato Natale, MD
A.O. Ospedali Riuniti Marche Nord - Presidio S. Salvatore Muraglia
Pesaro, PE, Italy
Status: Recruiting
Contact: Vincenzo Catalano, MD
Ospedale Civile Spirito Santo
Pescara, PE, Italy
Status: Recruiting
Contact: Marco Lombardo, MD
Ospedale Misericordia e Dolce
Prato, PO, Italy
Status: Recruiting
Contact: Andrea Ciarlo, MD
Azienda Ospedaliera Ospedale San Carlo
Potenza, PZ, Italy
Status: Recruiting
Contact: Domenico Bilancia, MD
Ospedale di S. Maria Nuova
Reggio Emilia, RE, Italy
Status: Recruiting
Contact: Corrado Boni, MD
Azienda Policlinico Umberto I
Roma, RM, Italy
Status: Recruiting
Contact: Enrico Cortesi, MD
Ospedale Fatebenefratelli
Roma, RM, Italy
Status: Recruiting
Contact: Domenico Cristiano Corsi, MD - +39 06 6837249
Azienda Ospedaliera Valtellina e Valchiavenna - Ospedale Civile
Sondrio, SO, Italy
Status: Recruiting
Contact: Alessandro Bertolini, MD
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, TO, Italy
Status: Recruiting
Contact: Libero Ciuffreda, MD
Ospedale Generale Provinciale di Saronno
Saronno, VA, Italy
Status: Recruiting
Contact: Claudio Verusio, MD
Ospedale di Circolo e Fondazione Macchi di Varese
Varese, VA, Italy
Status: Recruiting
Contact: Graziella Pinotti, MD
Ospedale Sacro Cuore Don Calabria di Negrar
Negrar, VR, Italy
Status: Recruiting
Contact: Massimo Cirillo, MD - +39 0456013472
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Napoli, Italy
Status: Recruiting
Contact: Rosario Vincenzo , Iaffaioli
Ospedale Policlinico G.B. Rossi (Borgo Roma) Di Verona
Verona, Italy
Status: Recruiting
Contact: Giampaolo Tortora, MD - +39 045 8128502 - giampaolo.tortora@univr.it
Start Date
January 2013
Completion Date
July 2017
Sponsors
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Source
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page