Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02076594
Recruitment Status : Terminated (The interim analysis performed on 09 November 2018, showed the failure to achieve the primary objective of effectiveness of the experimental treatment.)
First Posted : March 3, 2014
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
Regione Lombardia
Information provided by (Responsible Party):
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

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).

Condition or disease Intervention/treatment Phase
Locally Advanced Unresectable Gastric Cancer Metastatic Gastric Cancer Drug: Docetaxel Drug: Epirubicin Drug: Oxaliplatin Drug: Capecitabine Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2013
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 31, 2018


Arm Intervention/treatment
Experimental: 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)
Drug: Docetaxel
Powder for solution for infusion
Other Name: Taxotere 20 mg/mL

Drug: Oxaliplatin
Powder for solution for infusion
Other Name: Eloxatin 5 mg/mL

Drug: Capecitabine
Film coated tablets
Other Names:
  • Xeloda 150 mg
  • Xeloda 500 mg

Experimental: 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)
Drug: Epirubicin
Solution for infusion
Other Name: Farmorubicina 2mg/mL

Drug: Oxaliplatin
Powder for solution for infusion
Other Name: Eloxatin 5 mg/mL

Drug: Capecitabine
Film coated tablets
Other Names:
  • Xeloda 150 mg
  • Xeloda 500 mg




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 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 ]
    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)


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Measured as the time from randomization to the date of death from any cause, assessed up to 18 months of follow up ]
    To assess overall survival (OS) 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)

  2. Objective Response Rate (CR + PR) according to RECIST 1.1 guideline [ Time Frame: Measured as the time from randomization, assessed up to 18 months of follow up ]
    To assess objective response rate (CR+PR)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)

  3. Disease control rate: CR + PR + SD lasting > 12 weeks [ Time Frame: Measured as the time from randomization, assessed up to 18 months of follow up ]
    To assess disease control rate 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)

  4. 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 [ Time Frame: Measured as the time from randomization, assessed up to 18 months of follow up ]
    To assess tolerability of the treatments 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076594


Locations
Show Show 25 study locations
Sponsors and Collaborators
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Regione Lombardia
Investigators
Layout table for investigator information
Study Director: Roberto Labianca, MD A.O. Papa Giovanni XXIII di Bergamo, Oncologia Medica
Principal Investigator: 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

Layout table for additonal information
Responsible Party: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
ClinicalTrials.gov Identifier: NCT02076594    
Other Study ID Numbers: LEGA
2011-005537-39 ( EudraCT Number )
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Capecitabine
Oxaliplatin
Epirubicin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors