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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
171
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Istituto Tumori
Bari, BA, Italy
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)
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
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)
Time frame: 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
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)
Time frame: Measured as the time from randomization, assessed up to 18 months of follow up
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)
Time frame: 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
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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
...and 15 more locations
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)
Time frame: Measured as the time from randomization, assessed up to 18 months of follow up