Low-Tox Vs Eox In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer
Launched by GRUPPO ITALIANO PER LO STUDIO DEI CARCINOMI DELL'APPARATO DIGERENTE · Feb 26, 2014
Trial Information
Current as of May 18, 2025
Terminated
Keywords
ClinConnect Summary
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 anthracy...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Signed written informed consent prior to beginning protocol specific procedures
- • Male or female \> 18 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 0-2 at study entry
- • Neutrophils \>/= 2.0 x 1000000000/L, platelets \>/= 100 x 1000000000/L, and hemoglobin \>/= 10 g/dL
- • Bilirubin level either normal or \</= 1.5 x ULN
- • AST and ALT \</= 2.5 X UNL (\</= 5 x ULN if liver metastasis are present
- • Alkaline phosphatase (ALP) \</= 2.5 X ULN; patients with alkaline phosphatase \> 2.5x ULN and AST and ALT \</= 1.5 x ULN are equally eligible
- • 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)
About Gruppo Italiano Per Lo Studio Dei Carcinomi Dell'apparato Digerente
The Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato Digerente (GISCAD) is a prominent Italian organization dedicated to advancing research and clinical trials in gastrointestinal cancers. Comprising a multidisciplinary team of oncologists, researchers, and healthcare professionals, GISCAD focuses on improving patient outcomes through innovative therapeutic approaches and comprehensive studies. The group is committed to fostering collaboration among institutions and enhancing the understanding of digestive system carcinomas through rigorous scientific inquiry, thereby contributing to the development of effective treatment strategies and improved standards of care in oncology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Prato, Po, Italy
Milano, Mi, Italy
Bergamo, Bg, Italy
Como, Co, Italy
Milano, Mi, Italy
Piacenza, Pc, Italy
Potenza, Pz, Italy
Bari, Ba, Italy
Treviglio, Bg, Italy
Monserrato, Ca, Italy
Lecco, Lc, Italy
Latina, Lt, Italy
Camaiore, Lu, Italy
Taormina, Me, Italy
Gorgonzola, Mi, Italy
Milano, Mi, Italy
Milano, Mi, Italy
Carpi, Mo, Italy
Pesaro, Pe, Italy
Pescara, Pe, Italy
Reggio Emilia, Re, Italy
Roma, Rm, Italy
Varese, Va, Italy
Negrar, Vr, Italy
Napoli, , Italy
Milano, Lombardia, Italy
Patients applied
Trial Officials
Roberto Labianca, MD
Study Director
A.O. Papa Giovanni XXIII di Bergamo, Oncologia Medica
Enrico Cortesi, MD
Principal Investigator
Policlinico Umbero I di Roma, UOC Oncologia Medica B
Domenico Cristiano Corsi, MD
Principal Investigator
Ospedale Fatebenefratelli di Roma, Oncologia
Pietro Sozzi, MD
Principal Investigator
Ospedale degli Infermi di Biella, Oncologia
Luigi Cavanna, MD
Principal Investigator
AUSL di Piacenza, Oncologia Medica
Domenico Bilancia, MD
Principal Investigator
A.O. Ospedale San Carlo di Potenza, Oncologia Medica
Rosa Rita Silva, MD
Principal Investigator
ASUR Zona 6 di Fabriano, Oncologia
Nicola Fazio, MD
Principal Investigator
IRCCS Istituto Europeo di Oncologia di Milano, Tumori digestivi superiori e Neuroendocrini
Monica Giordano, MD
Principal Investigator
A. O. Sant'Anna di Como, Oncologia
Alessandro Bertolini, MD
Principal Investigator
Ospedale Civile di Sondrio, Oncologia Medica
Giovanni Ucci, MD
Principal Investigator
A.O. Ospedale Maggiore di Lodi, Oncologia
Donato Natale, MD
Principal Investigator
A.O. di Pescara - Oncologia
Daris Ferrari, MD
Principal Investigator
A.O. San Paolo di Milano, Oncologia Medica
Graziella Pinotti, MD
Principal Investigator
Ospedale di Circolo e Fondazione Macchi di Varese, Oncologia
Ermanno Rondini, MD
Principal Investigator
Ospedale di S. Maria Nuova di Reggio Emilia, Oncologia Medica
Massimo Cirillo, MD
Principal Investigator
Ospedale Sacro Cuore Don Calabria di Negrar, Oncologia Medica
Rosario Vincenzo Iaffaioli, MD
Principal Investigator
IRCCS Istituto Nazionale Tumori Fondazione Pascale di Napoli, Oncologia Medica Addominale
Andrea Ciarlo, MD
Principal Investigator
Ospedale Misericordia e Dolce di Prato, Oncologia Medica
Elena Piazza, MD
Principal Investigator
Ospedale L. Sacco di Milano, Oncologia
Libero Ciuffreda, MD
Principal Investigator
Azienda Ospedaliera Città della Salute e della Scienza di Torino, Oncologia Medica
Stefania Dell'Oro, MD
Principal Investigator
Ospedale di Circolo A. Manzoni di Lecco, Oncologia Medica
Fabrizio Artioli, MD
Principal Investigator
Ospedale di Carpi, Medicina Oncologica
Claudio Verusio, MD
Principal Investigator
Ospedale Generale Provinciale di Saronno, Oncologia Medica
Vincenzo Catalano, MD
Principal Investigator
A.O. Ospedali Riuniti Marche Nord - Presidio S. Salvatore Muraglia, Oncologia
Claudio Graiff, MD
Principal Investigator
ASDAA Bolzano, Oncologia Medica
Domenico Amoroso, MD
Principal Investigator
A.O. Ospedale Versilia di Camaiore, Oncologia Medica
Maria Di Bartolomeo, MD
Principal Investigator
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Medicina Oncologica 1
Nicola Silvestris, MD
Principal Investigator
Istituto Tumori di Bari, Oncologia Medica
Maria C. Zavettieri, MD
Principal Investigator
OSPED. DI CIRCOLO SERBELLONI-GORGONZOLA - GORGONZOLA (MI)
Enzo Veltri, MD
Principal Investigator
OSPEDALE SANTA MARIA GORETTI LATINA
Francesco Ferraù, MD
Principal Investigator
P.O. "SAN VINCENZO" TAORMINA - TAORMINA (ME)
Giampaolo Tortora, MD
Principal Investigator
OSPEDALE POLICLINICO G.B. ROSSI (BORGO ROMA) DI VERONA
Sandro Barni, MD
Principal Investigator
A.O. TREVIGLIO-CARAVAGGIO - TREVIGLIO (BG)
Mario Scartozzi, MD
Principal Investigator
A.O.U. di Cagliari - Presidio di Monserrato
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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