Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer (PRODIGY)

• Overall survival (OS) [ Time Frame: Up to a maximum of 5 years ] [ Designated as safety issue: No ]
• Stage distribution in both groups assessed after surgery [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
• RO resection rate [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
• Number of patients with adverse events [ Time Frame: Up to a maximum of 5 years ] [ Designated as safety issue: Yes ]

Primary Objective:

- To compare progression free survival (PFS) in the two treatment arms

Secondary Objectives:

• Overall survival (OS)
• Postoperative stage and R0 (complete) resection rate
• Safety: Toxicities associated with neoadjuvant chemotherapy, surgery, morbidity/mortality, toxicity of adjuvant chemotherapy1

Patients in the neoadjuvant chemotherapy arm will be treated for 3 cycles (1 cycle is 21 days) before surgery and treated for a year with TS-1 Patients in the adjuvant chemotherapy arm will get a surgery and treated for a year with TS-1. All patients will be followed during and after the study treatment until death or progression, whichever comes first.

• Drug: DOCETAXEL (XRP6976)
  Pharmaceutical form:solution for infusion Route of administration: intravenous
• Drug: OXALIPLATIN (SR96669)
  Pharmaceutical form:solution for infusion Route of administration: intravenous
• Drug: S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + CDHP (Gemeracil) + Oxo (Oteracil)
  Pharmaceutical form:Tablet Route of administration: Oral

• Experimental: neoadjuvant chemotherapy + surgery + adjuvant chemotherapy
  Docetaxel 50 mg/m² for day 1 , Oxaliplatin 100 mg/m² for day 1, S-1 80 mg/m²/day from day 1 to day 14 + surgery + S-1 80 mg/m²/day for 1yr
  Interventions:

  • Drug: DOCETAXEL (XRP6976)
  • Drug: OXALIPLATIN (SR96669)
• surgery + adjuvant chemotherapy
  surgery + S-1 80 mg/m²/day for 1yr
  Intervention: Drug: S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + CDHP (Gemeracil) + Oxo (Oteracil)

Inclusion criteria :

• Patients with histologically confirmed, newly diagnosed, localized gastric or gastro-oesophageal adenocarcinoma, that is considered resectable
• Patients with clinical stage(T2-3/N(+), T4/N(+/-) :N positive means ≥8 in short axis)
• Signed informed consent

Exclusion criteria:

• Age <20 years or ≥76 years Performance status ≥2 in Eastern Cooperative Oncology Group (ECOG) scale
• The patients who have the history of other malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix which have been already successfully treated
• Previous surgery on neoplasm of stomach
• Patients who have not completely recovered from surgery
• Distant metastases (M1) to other organs including distant nodal groups (retropancreatic, para-aortic, portal, retroperitoneal, mesenteric node). severe/unstable angina, coronary artery bypass graft, congestive heart failure, transient ischemic attack within 6 months prior to enrollment in the study
• Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy, for the currently treated gastric cancer
• Patients with active active infection or sepsis
• Intolerance of oral taking or malabsorption: lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of TS-1. Ileus, chronic inflammatory intestinal disease or extensive resection of the small intestine and other disorders which limit drug resorption. This includes gastric dumping syndrome, indications of accelerated passage through the small intestine and indications of resorption disorders after intestinal surgery
• ≥ grade 2 severe tumour haemorrhage
• Simultaneous participation in another study, or participation in another study within 4 weeks of commencement of this study
• Pregnant or lactating patients

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.