Spots Global Cancer Trial Database for Low-Tox Vs Eox In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Low-Tox Vs Eox In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer
Official Title: A Randomized Phase III Study Of Low-Docetaxel Oxaliplatin, Capecitabine (Low-Tox) Vs Epirubicin, Oxaliplatin And Capecitabine (Eox) In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer
Study ID: NCT02076594
Study Description
Brief 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, 1 and 2).
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Istituto Tumori, Bari, BA, Italy
Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, BG, Italy
A.O. Treviglio-Caravaggio, Treviglio, BG, Italy
Azienda Ospedaliera Universitaria di Cagliari, Monserrato, CA, Italy
Azienda Ospedaliera Sant'Anna, Como, CO, Italy
Ospedale di Circolo A. Manzoni, Lecco, LC, Italy
Ospedale Santa Maria Goretti Latina, Latina, LT, Italy
A.O. Ospedale Versilia, Camaiore, LU, Italy
P.O. "San Vincenzo" Taormina, Taormina, ME, Italy
Osped. Di Circolo Serbelloni-Gorgonzola, Gorgonzola, MI, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, MI, Italy
IRCCS Istituto Europeo di Oncologia (IEO), Milano, MI, Italy
Azienda Ospedaliera San Paolo, Milano, MI, Italy
Ospedale L. Sacco, Milano, MI, Italy
Ospedale di Carpi, Carpi, MO, Italy
AUSL di Piacenza, Piacenza, PC, Italy
A.O. Ospedali Riuniti Marche Nord - Presidio S. Salvatore Muraglia, Pesaro, PE, Italy
A. O. di Pescara - Ospedale Civile Spirito Santo, Pescara, PE, Italy
Ospedale Misericordia e Dolce, Prato, PO, Italy
Azienda Ospedaliera Ospedale San Carlo, Potenza, PZ, Italy
Ospedale di S. Maria Nuova, Reggio Emilia, RE, Italy
Ospedale Fatebenefratelli, Roma, RM, Italy
Ospedale di Circolo e Fondazione Macchi di Varese, Varese, VA, Italy
Ospedale Sacro Cuore Don Calabria di Negrar, Negrar, VR, Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale, Napoli, , Italy
Contact Details
Name: Roberto Labianca, MD
Affiliation: A.O. Papa Giovanni XXIII di Bergamo, Oncologia Medica
Role: STUDY_DIRECTOR
Name: Enrico Cortesi, MD
Affiliation: Policlinico Umbero I di Roma, UOC Oncologia Medica B
Role: PRINCIPAL_INVESTIGATOR
Name: Domenico Cristiano Corsi, MD
Affiliation: Ospedale Fatebenefratelli di Roma, Oncologia
Role: PRINCIPAL_INVESTIGATOR
Name: Pietro Sozzi, MD
Affiliation: Ospedale degli Infermi di Biella, Oncologia
Role: PRINCIPAL_INVESTIGATOR
Name: Luigi Cavanna, MD
Affiliation: AUSL di Piacenza, Oncologia Medica
Role: PRINCIPAL_INVESTIGATOR
Name: Domenico Bilancia, MD
Affiliation: A.O. Ospedale San Carlo di Potenza, Oncologia Medica
Role: PRINCIPAL_INVESTIGATOR
Name: Rosa Rita Silva, MD
Affiliation: ASUR Zona 6 di Fabriano, Oncologia
Role: PRINCIPAL_INVESTIGATOR
Name: Nicola Fazio, MD
Affiliation: IRCCS Istituto Europeo di Oncologia di Milano, Tumori digestivi superiori e Neuroendocrini
Role: PRINCIPAL_INVESTIGATOR
Name: Monica Giordano, MD
Affiliation: A. O. Sant'Anna di Como, Oncologia
Role: PRINCIPAL_INVESTIGATOR
Name: Alessandro Bertolini, MD
Affiliation: Ospedale Civile di Sondrio, Oncologia Medica
Role: PRINCIPAL_INVESTIGATOR
Name: Giovanni Ucci, MD
Affiliation: A.O. Ospedale Maggiore di Lodi, Oncologia
Role: PRINCIPAL_INVESTIGATOR
Name: Donato Natale, MD
Affiliation: A.O. di Pescara - Oncologia
Role: PRINCIPAL_INVESTIGATOR
Name: Daris Ferrari, MD
Affiliation: A.O. San Paolo di Milano, Oncologia Medica
Role: PRINCIPAL_INVESTIGATOR
Name: Graziella Pinotti, MD
Affiliation: Ospedale di Circolo e Fondazione Macchi di Varese, Oncologia
Role: PRINCIPAL_INVESTIGATOR
Name: Ermanno Rondini, MD
Affiliation: Ospedale di S. Maria Nuova di Reggio Emilia, Oncologia Medica
Role: PRINCIPAL_INVESTIGATOR
Name: Massimo Cirillo, MD
Affiliation: Ospedale Sacro Cuore Don Calabria di Negrar, Oncologia Medica
Role: PRINCIPAL_INVESTIGATOR
Name: Rosario Vincenzo Iaffaioli, MD
Affiliation: IRCCS Istituto Nazionale Tumori Fondazione Pascale di Napoli, Oncologia Medica Addominale
Role: PRINCIPAL_INVESTIGATOR
Name: Andrea Ciarlo, MD
Affiliation: Ospedale Misericordia e Dolce di Prato, Oncologia Medica
Role: PRINCIPAL_INVESTIGATOR
Name: Elena Piazza, MD
Affiliation: Ospedale L. Sacco di Milano, Oncologia
Role: PRINCIPAL_INVESTIGATOR
Name: Libero Ciuffreda, MD
Affiliation: Azienda Ospedaliera Città della Salute e della Scienza di Torino, Oncologia Medica
Role: PRINCIPAL_INVESTIGATOR
Name: Stefania Dell'Oro, MD
Affiliation: Ospedale di Circolo A. Manzoni di Lecco, Oncologia Medica
Role: PRINCIPAL_INVESTIGATOR
Name: Fabrizio Artioli, MD
Affiliation: Ospedale di Carpi, Medicina Oncologica
Role: PRINCIPAL_INVESTIGATOR
Name: Claudio Verusio, MD
Affiliation: Ospedale Generale Provinciale di Saronno, Oncologia Medica
Role: PRINCIPAL_INVESTIGATOR
Name: Vincenzo Catalano, MD
Affiliation: A.O. Ospedali Riuniti Marche Nord - Presidio S. Salvatore Muraglia, Oncologia
Role: PRINCIPAL_INVESTIGATOR
Name: Claudio Graiff, MD
Affiliation: ASDAA Bolzano, Oncologia Medica
Role: PRINCIPAL_INVESTIGATOR
Name: Domenico Amoroso, MD
Affiliation: A.O. Ospedale Versilia di Camaiore, Oncologia Medica
Role: PRINCIPAL_INVESTIGATOR
Name: Maria Di Bartolomeo, MD
Affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Medicina Oncologica 1
Role: PRINCIPAL_INVESTIGATOR
Name: Nicola Silvestris, MD
Affiliation: Istituto Tumori di Bari, Oncologia Medica
Role: PRINCIPAL_INVESTIGATOR
Name: Maria C. Zavettieri, MD
Affiliation: OSPED. DI CIRCOLO SERBELLONI-GORGONZOLA - GORGONZOLA (MI)
Role: PRINCIPAL_INVESTIGATOR
Name: Enzo Veltri, MD
Affiliation: OSPEDALE SANTA MARIA GORETTI LATINA
Role: PRINCIPAL_INVESTIGATOR
Name: Francesco Ferraù, MD
Affiliation: P.O. "SAN VINCENZO" TAORMINA - TAORMINA (ME)
Role: PRINCIPAL_INVESTIGATOR
Name: Giampaolo Tortora, MD
Affiliation: OSPEDALE POLICLINICO G.B. ROSSI (BORGO ROMA) DI VERONA
Role: PRINCIPAL_INVESTIGATOR
Name: Sandro Barni, MD
Affiliation: A.O. TREVIGLIO-CARAVAGGIO - TREVIGLIO (BG)
Role: PRINCIPAL_INVESTIGATOR
Name: Mario Scartozzi, MD
Affiliation: A.O.U. di Cagliari - Presidio di Monserrato
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
