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

NCT02076594 | Terminated Phase 3

• 2 other identifiers: LEGA2011-005537-39
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 25

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).

Conditions

Locally Advanced Unresectable Gastric Cancer; Metastatic Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  To determine the progression free survival (PFS) of patients with locally advanced unresectable or metastatic gastric cancer treated with Docetaxel plus Oxaliplatin plus Capecitabine (Arm A) or with Epirubicin plus Oxaliplatin plus Capecitabine (Arm B)

  Measured as the time from randomization to the date of local or regional progression, distant metastasis, second primary malignancy or death, assessed up to 18 months of follow up

Secondary Outcomes (4)

• Overall Survival (OS)

  Measured as the time from randomization to the date of death from any cause, assessed up to 18 months of follow up

• Objective Response Rate (CR + PR) according to RECIST 1.1 guideline

  Measured as the time from randomization, assessed up to 18 months of follow up

• Disease control rate: CR + PR + SD lasting > 12 weeks

  Measured as the time from randomization, assessed up to 18 months of follow up

• Tolerability of the treatments evaluated in term of occurrence of: side effects graded according to the NCI-CTCAE scale (version 4.0); serious adverse reactions, expected and unexpected

  Measured as the time from randomization, assessed up to 18 months of follow up

Study Arms (2)

Docetaxel & Oxaliplatin & Capecitabine

EXPERIMENTAL

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)

Drug: Docetaxel; Drug: Oxaliplatin; Drug: Capecitabine

Epirubicin & Oxaliplatin & Capecitabine

EXPERIMENTAL

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)

Drug: Epirubicin; Drug: Oxaliplatin; Drug: Capecitabine

Interventions

Docetaxel DRUG

Powder for solution for infusion

Also known as: Taxotere 20 mg/mL

Docetaxel & Oxaliplatin & Capecitabine

Epirubicin DRUG

Solution for infusion

Also known as: Farmorubicina 2mg/mL

Epirubicin & Oxaliplatin & Capecitabine

Oxaliplatin DRUG

Powder for solution for infusion

Also known as: Eloxatin 5 mg/mL

Docetaxel & Oxaliplatin & Capecitabine; Epirubicin & Oxaliplatin & Capecitabine

Capecitabine DRUG

Film coated tablets

Also known as: Xeloda 150 mg, Xeloda 500 mg

Docetaxel & Oxaliplatin & Capecitabine; Epirubicin & Oxaliplatin & Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente: lead
• Regione Lombardia: collaborator

Study Sites (25)

Istituto Tumori

Bari, BA, 70124, Italy

Location

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, BG, 24127, Italy

Location

A.O. Treviglio-Caravaggio

Treviglio, BG, 24047, Italy

Location

Azienda Ospedaliera Universitaria di Cagliari

Monserrato, CA, 09042, Italy

Location

Azienda Ospedaliera Sant'Anna

Como, CO, 22020, Italy

Location

Ospedale di Circolo A. Manzoni

Lecco, LC, 23900, Italy

Location

Ospedale Santa Maria Goretti Latina

Latina, LT, 04100, Italy

Location

A.O. Ospedale Versilia

Camaiore, LU, 55041, Italy

Location

P.O. "San Vincenzo" Taormina

Taormina, ME, 98039, Italy

Location

Osped. Di Circolo Serbelloni-Gorgonzola

Gorgonzola, MI, 20064, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, MI, 20133, Italy

Location

IRCCS Istituto Europeo di Oncologia (IEO)

Milan, MI, 20141, Italy

Location

Azienda Ospedaliera San Paolo

Milan, MI, 20142, Italy

Location

Ospedale L. Sacco

Milan, MI, 20157, Italy

Location

Ospedale di Carpi

Carpi, MO, 41012, Italy

Location

AUSL di Piacenza

Piacenza, PC, 29100, Italy

Location

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

Pesaro, PE, 61122, Italy

Location

A. O. di Pescara - Ospedale Civile Spirito Santo

Pescara, PE, 65124, Italy

Location

Ospedale Misericordia e Dolce

Prato, PO, 59100, Italy

Location

Azienda Ospedaliera Ospedale San Carlo

Potenza, PZ, 85100, Italy

Location

Ospedale di S. Maria Nuova

Reggio Emilia, RE, 42100, Italy

Location

Ospedale Fatebenefratelli

Roma, RM, 00186, Italy

Location

Ospedale di Circolo e Fondazione Macchi di Varese

Varese, VA, 21100, Italy

Location

Ospedale Sacro Cuore Don Calabria di Negrar

Negrar, VR, 37024, Italy

Location

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Napoli, 80131, Italy

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; Epirubicin; Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Roberto Labianca, MD

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

  STUDY DIRECTOR

• Enrico Cortesi, MD

  Policlinico Umbero I di Roma, UOC Oncologia Medica B

  PRINCIPAL INVESTIGATOR

• Domenico Cristiano Corsi, MD

  Ospedale Fatebenefratelli di Roma, Oncologia

  PRINCIPAL INVESTIGATOR

• Pietro Sozzi, MD

  Ospedale degli Infermi di Biella, Oncologia

  PRINCIPAL INVESTIGATOR

• Luigi Cavanna, MD

  AUSL di Piacenza, Oncologia Medica

  PRINCIPAL INVESTIGATOR

• Domenico Bilancia, MD

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

  PRINCIPAL INVESTIGATOR

• Rosa Rita Silva, MD

  ASUR Zona 6 di Fabriano, Oncologia

  PRINCIPAL INVESTIGATOR

• Nicola Fazio, MD

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

  PRINCIPAL INVESTIGATOR

• Monica Giordano, MD

  A. O. Sant'Anna di Como, Oncologia

  PRINCIPAL INVESTIGATOR

• Alessandro Bertolini, MD

  Ospedale Civile di Sondrio, Oncologia Medica

  PRINCIPAL INVESTIGATOR

• Giovanni Ucci, MD

  A.O. Ospedale Maggiore di Lodi, Oncologia

  PRINCIPAL INVESTIGATOR

• Donato Natale, MD

  A.O. di Pescara - Oncologia

  PRINCIPAL INVESTIGATOR

• Daris Ferrari, MD

  A.O. San Paolo di Milano, Oncologia Medica

  PRINCIPAL INVESTIGATOR

• Graziella Pinotti, MD

  Ospedale di Circolo e Fondazione Macchi di Varese, Oncologia

  PRINCIPAL INVESTIGATOR

• Ermanno Rondini, MD

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

  PRINCIPAL INVESTIGATOR

• Massimo Cirillo, MD

  Ospedale Sacro Cuore Don Calabria di Negrar, Oncologia Medica

  PRINCIPAL INVESTIGATOR

• Rosario Vincenzo Iaffaioli, MD

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

  PRINCIPAL INVESTIGATOR

• Andrea Ciarlo, MD

  Ospedale Misericordia e Dolce di Prato, Oncologia Medica

  PRINCIPAL INVESTIGATOR

• Elena Piazza, MD

  Ospedale L. Sacco di Milano, Oncologia

  PRINCIPAL INVESTIGATOR

• Libero Ciuffreda, MD

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

  PRINCIPAL INVESTIGATOR

• Stefania Dell'Oro, MD

  Ospedale di Circolo A. Manzoni di Lecco, Oncologia Medica

  PRINCIPAL INVESTIGATOR

• Fabrizio Artioli, MD

  Ospedale di Carpi, Medicina Oncologica

  PRINCIPAL INVESTIGATOR

• Claudio Verusio, MD

  Ospedale Generale Provinciale di Saronno, Oncologia Medica

  PRINCIPAL INVESTIGATOR

• Vincenzo Catalano, MD

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

  PRINCIPAL INVESTIGATOR

• Claudio Graiff, MD

  ASDAA Bolzano, Oncologia Medica

  PRINCIPAL INVESTIGATOR

• Domenico Amoroso, MD

  A.O. Ospedale Versilia di Camaiore, Oncologia Medica

  PRINCIPAL INVESTIGATOR

• Maria Di Bartolomeo, MD

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

  PRINCIPAL INVESTIGATOR

• Nicola Silvestris, MD

  Istituto Tumori di Bari, Oncologia Medica

  PRINCIPAL INVESTIGATOR

• Maria C. Zavettieri, MD

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

  PRINCIPAL INVESTIGATOR

• Enzo Veltri, MD

  OSPEDALE SANTA MARIA GORETTI LATINA

  PRINCIPAL INVESTIGATOR

• Francesco Ferraù, MD

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

  PRINCIPAL INVESTIGATOR

• Giampaolo Tortora, MD

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

  PRINCIPAL INVESTIGATOR

• Sandro Barni, MD

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

  PRINCIPAL INVESTIGATOR

• Mario Scartozzi, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: March 3, 2014
• Study Start: January 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 31, 2018
• Last Updated: October 9, 2019

Record last verified: 2019-01

Locations

IT (25)