Low-Tox Vs Eox In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer

NCT ID: NCT02076594

Last Updated: 2019-10-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2018-12-31

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.

Conditions

Locally Advanced Unresectable Gastric Cancer; Metastatic Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Docetaxel & Oxaliplatin & Capecitabine

Patients will receive cycles every 3 weeks of Docetaxel (35 mg/ m2, intravenous at days 1 and 8 by 1-hour infusion)and Oxaliplatin (80 mg/ m2, intravenous at day 1 by 2-hour infusion) and Capecitabine (750 mg/ m2, oral tablets of 500 and 150 mg, x2 daily for 2 weeks)

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Powder for solution for infusion

Oxaliplatin

Intervention Type: DRUG

Powder for solution for infusion

Capecitabine

Intervention Type: DRUG

Film coated tablets

Epirubicin & Oxaliplatin & Capecitabine

Patients will receive cycles every 3 weeks of Epirubicin (50 mg/ m2, intravenous on day 1 by 2-hour infusion)and Oxaliplatin (130 mg/ m2, intravenous on day 1 by 2-hour infusion) and Capecitabine (625 mg/ m2,oral tablets of 500 and 150 mg, x2 daily for 3 weeks)

Group Type: EXPERIMENTAL

Epirubicin

Intervention Type: DRUG

Solution for infusion

Oxaliplatin

Intervention Type: DRUG

Powder for solution for infusion

Capecitabine

Intervention Type: DRUG

Film coated tablets

Interventions

Docetaxel

Powder for solution for infusion

Intervention Type: DRUG

Epirubicin

Solution for infusion

Intervention Type: DRUG

Oxaliplatin

Powder for solution for infusion

Intervention Type: DRUG

Capecitabine

Film coated tablets

Intervention Type: DRUG

Other Intervention Names

Taxotere 20 mg/mL; Farmorubicina 2mg/mL; Eloxatin 5 mg/mL; Xeloda 150 mg; Xeloda 500 mg

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regione Lombardia

OTHER

Sponsor Role: collaborator

Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberto Labianca, MD

Role: STUDY_DIRECTOR

A.O. Papa Giovanni XXIII di Bergamo, Oncologia Medica

Enrico Cortesi, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico Umbero I di Roma, UOC Oncologia Medica B

Domenico Cristiano Corsi, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Fatebenefratelli di Roma, Oncologia

Pietro Sozzi, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale degli Infermi di Biella, Oncologia

Luigi Cavanna, MD

Role: PRINCIPAL_INVESTIGATOR

AUSL di Piacenza, Oncologia Medica

Domenico Bilancia, MD

Role: PRINCIPAL_INVESTIGATOR

A.O. Ospedale San Carlo di Potenza, Oncologia Medica

Rosa Rita Silva, MD

Role: PRINCIPAL_INVESTIGATOR

ASUR Zona 6 di Fabriano, Oncologia

Nicola Fazio, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Europeo di Oncologia di Milano, Tumori digestivi superiori e Neuroendocrini

Monica Giordano, MD

Role: PRINCIPAL_INVESTIGATOR

A. O. Sant'Anna di Como, Oncologia

Alessandro Bertolini, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Civile di Sondrio, Oncologia Medica

Giovanni Ucci, MD

Role: PRINCIPAL_INVESTIGATOR

A.O. Ospedale Maggiore di Lodi, Oncologia

Donato Natale, MD

Role: PRINCIPAL_INVESTIGATOR

A.O. di Pescara - Oncologia

Daris Ferrari, MD

Role: PRINCIPAL_INVESTIGATOR

A.O. San Paolo di Milano, Oncologia Medica

Graziella Pinotti, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale di Circolo e Fondazione Macchi di Varese, Oncologia

Ermanno Rondini, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale di S. Maria Nuova di Reggio Emilia, Oncologia Medica

Massimo Cirillo, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Sacro Cuore Don Calabria di Negrar, Oncologia Medica

Rosario Vincenzo Iaffaioli, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Nazionale Tumori Fondazione Pascale di Napoli, Oncologia Medica Addominale

Andrea Ciarlo, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Misericordia e Dolce di Prato, Oncologia Medica

Elena Piazza, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale L. Sacco di Milano, Oncologia

Libero Ciuffreda, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Oncologia Medica

Stefania Dell'Oro, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale di Circolo A. Manzoni di Lecco, Oncologia Medica

Fabrizio Artioli, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale di Carpi, Medicina Oncologica

Claudio Verusio, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Generale Provinciale di Saronno, Oncologia Medica

Vincenzo Catalano, MD

Role: PRINCIPAL_INVESTIGATOR

A.O. Ospedali Riuniti Marche Nord - Presidio S. Salvatore Muraglia, Oncologia

Claudio Graiff, MD

Role: PRINCIPAL_INVESTIGATOR

ASDAA Bolzano, Oncologia Medica

Domenico Amoroso, MD

Role: PRINCIPAL_INVESTIGATOR

A.O. Ospedale Versilia di Camaiore, Oncologia Medica

Maria Di Bartolomeo, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Medicina Oncologica 1

Nicola Silvestris, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Tumori di Bari, Oncologia Medica

Maria C. Zavettieri, MD

Role: PRINCIPAL_INVESTIGATOR

OSPED. DI CIRCOLO SERBELLONI-GORGONZOLA - GORGONZOLA (MI)

Enzo Veltri, MD

Role: PRINCIPAL_INVESTIGATOR

OSPEDALE SANTA MARIA GORETTI LATINA

Francesco Ferraù, MD

Role: PRINCIPAL_INVESTIGATOR

P.O. "SAN VINCENZO" TAORMINA - TAORMINA (ME)

Giampaolo Tortora, MD

Role: PRINCIPAL_INVESTIGATOR

OSPEDALE POLICLINICO G.B. ROSSI (BORGO ROMA) DI VERONA

Sandro Barni, MD

Role: PRINCIPAL_INVESTIGATOR

A.O. TREVIGLIO-CARAVAGGIO - TREVIGLIO (BG)

Mario Scartozzi, MD

Role: PRINCIPAL_INVESTIGATOR

A.O.U. di Cagliari - Presidio di Monserrato

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

Milan, MI, Italy

IRCCS Istituto Europeo di Oncologia (IEO)

Milan, MI, Italy

Azienda Ospedaliera San Paolo

Milan, MI, Italy

Ospedale L. Sacco

Milan, 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

Countries

Italy

Other Identifiers

2011-005537-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LEGA

Identifier Type: -

Identifier Source: org_study_id