Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Docetaxel (XRP6976); Oxaliplatin (SR96669); S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + 5-chloro-2, 4-dihydroxypyridine (CDHP) (Gimeracil) + Oxo (Oteracil)
Intervention description: Pharmaceutical form:solution for infusion Route of administration: intravenous; Pharmaceutical form:solution for infusion Route of administration: intravenous; Pharmaceutical form:Tablet Route of administration: Oral
Intervention MeSH terms: Docetaxel; Fluorouracil; Oxaliplatin; Tegafur
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 530.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      - To compare the 3-year progression free survival (PFS) in the two treatment arms.

      Secondary Objectives:

        -  Overall survival (OS).

        -  Postoperative pathological stage and R0 (complete) resection rate.

        -  Safety: Toxicities associated with neoadjuvant chemotherapy, surgery,
           morbidity/mortality, toxicity of adjuvant chemotherapy.
    

Eligibility criteria:

        Inclusion criteria :

          -  Participants with new histologically confirmed, newly diagnosed, localized gastric or
             gastro-oesophageal adenocarcinoma, that is considered resectable.

          -  Participants with clinical stage (T2-3/N(+), T4/N(+/-):N positive means greater than
             or equal to [>=] 8 in hour axis).

          -  Signed informed consent.

        Exclusion criteria:

          -  Aged less than (<) 20 years or >= 76 years. Performance status >=2 in Eastern
             Cooperative Oncology Group (ECOG) scale

          -  The participants who had 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 had been already successfully treated.

          -  Previous surgery on neoplasm of stomach.

          -  Participants who did 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.

          -  Participants with 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 S-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.

          -  Greater than or equal to 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 participants.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.