NCT02076594.

Trial name or 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
Methods	Phase 3 Allocation: Randomised Intervention Model: Parallel assignment Masking: Open‐label Primary Purpose: Treatment
Participants	N = 462 Age 18 to 69 years · Histologically proven diagnosis of adenocarcinoma of the stomach · HER2 negative tumour or HER2+ tumours not qualifying for herceptin therapy · Locally advanced (non resectable) or metastatic gastric cancer
Interventions	Experimental arm A: docetaxel & oxaliplatin & capecitabine Participants 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 mg and 150 mg, x2 daily for 2 weeks) Experimental arm B: epirubicin & oxaliplatin & capecitabine Participants 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 mg and 150 mg, x2 daily for 3 weeks)
Outcomes	Overall survival (OS) [Time frame: Measured as the time from randomisation to the date of death from any cause, assessed up to 18 months of follow‐up] Progression‐free survival (PFS) [Time frame: Measured as the time from randomisation to the date of local or regional progression, distant metastasis, second primary malignancy or death from any cause, whichever comes first, assessed up to 18 months of follow‐up] Objective Response Rate (CR + PR) according to RECIST 1.1 guideline [Time frame: Measured as the time from randomisation, assessed up to 18 months of follow‐up] Disease control rate: CR + PR + SD lasting > 12 weeks [Time frame: Measured as the time from randomisation, assessed up to 18 months of follow‐up] To assess tolerability of the treatments of participants 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)
Starting date	January 2013
Contact information	Contact: Roberto Labianca, MD +39 035 2673691 rlabianca@hpg23.it
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