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Locally Advanced Unresectable Gastric CancerPhase 3NCT02076594

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

A Phase 3 study testing Docetaxel, Epirubicin and Oxaliplatin in people with Locally Advanced Unresectable Gastric Cancer and Metastatic Gastric Cancer, run by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente at 25 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Docetaxel, Epirubicin and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
171 participants
Where
25 sitesItaly
Study dates
Jan 2013to 31 Dec 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Italy25 sites

  • Istituto Tumori

    Bari, BA, 70124

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, BG, 24127

  • A.O. Ospedale Versilia

    Camaiore, LU, 55041

  • Ospedale di Carpi

    Carpi, MO, 41012

  • Azienda Ospedaliera Sant'Anna

    Como, CO, 22020

  • Osped. Di Circolo Serbelloni-Gorgonzola

    Gorgonzola, MI, 20064

  • Ospedale Santa Maria Goretti Latina

    Latina, LT, 04100

  • Ospedale di Circolo A. Manzoni

    Lecco, LC, 23900

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, MI, 20133

  • IRCCS Istituto Europeo di Oncologia (IEO)

    Milan, MI, 20141

  • Azienda Ospedaliera San Paolo

    Milan, MI, 20142

  • Ospedale L. Sacco

    Milan, MI, 20157

  • Azienda Ospedaliera Universitaria di Cagliari

    Monserrato, CA, 09042

  • IRCCS Istituto Nazionale Tumori Fondazione Pascale

    Naples, 80131

  • Ospedale Sacro Cuore Don Calabria di Negrar

    Negrar, VR, 37024

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

    Pesaro, PE, 61122

  • A. O. di Pescara - Ospedale Civile Spirito Santo

    Pescara, PE, 65124

  • AUSL di Piacenza

    Piacenza, PC, 29100

  • Azienda Ospedaliera Ospedale San Carlo

    Potenza, PZ, 85100

  • Ospedale Misericordia e Dolce

    Prato, PO, 59100

  • Ospedale di S. Maria Nuova

    Reggio Emilia, RE, 42100

  • Ospedale Fatebenefratelli

    Roma, RM, 00186

  • P.O. "San Vincenzo" Taormina

    Taormina, ME, 98039

  • A.O. Treviglio-Caravaggio

    Treviglio, BG, 24047

  • Ospedale di Circolo e Fondazione Macchi di Varese

    Varese, VA, 21100

Other trials in Italy

About this study

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

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).

Read the 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.

Being tested
Docetaxel, Epirubicin, Oxaliplatin, Capecitabine
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Also called Taxotere 20 mg/mL

    Powder for solution for infusion

  • EpirubicinDrug

    Also called Farmorubicina 2mg/mL

    Solution for infusion

  • OxaliplatinDrug

    Also called Eloxatin 5 mg/mL

    Powder for solution for infusion

  • CapecitabineDrug

    Also called Xeloda 150 mg, Xeloda 500 mg

    Film coated tablets

Study groups in NCT02076594
Study groupRoleWhat they receive
Docetaxel & Oxaliplatin & CapecitabineExperimentalPatients 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)
Receives: Drug: Docetaxel; Drug: Oxaliplatin; Drug: Capecitabine
Epirubicin & Oxaliplatin & CapecitabineExperimentalPatients 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)
Receives: Drug: Epirubicin; Drug: Oxaliplatin; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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: 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)

  1. Overall Survival (OS)

    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)

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

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

    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)

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

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

    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)

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

  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

    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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2014 (estimated)
  2. Study startJan 2013
  3. Primary completionDec 2018
  4. Study completion31 Dec 2018

Why it stopped: The interim analysis performed on 09 November 2018, showed the failure to achieve the primary objective of effectiveness of the experimental treatment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02076594
Sponsor's protocol ID
LEGA
Other IDs
2011-005537-39
Status last verified
Jan 2019
First submitted
20 Aug 2013
Last updated
9 Oct 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel, Epirubicin and Oxaliplatin in people with Locally Advanced Unresectable Gastric Cancer and Metastatic Gastric Cancer, run by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente at 25 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The interim analysis performed on 09 November 2018, showed the failure to achieve the primary objective of effectiveness of the experimental treatment.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02076594.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019; AzTrials last refreshed its copy on 26 Oct 2026.

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