Clinical trial NCT00411229 (phase 3, status: completed)
Conditions: stomach neoplasms
ICD codes: D13.1, C16.9, C16.1, C16.2, D37.1, C16.8, C16.5
Drugs: capecitabine, oxaliplatin
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatory patients

          -  Karnofsky performance status of ≥70 %.

          -  Histologically confirmed gastric adenocarcinoma, staged pathologically, stage II
             (T2N1, T1N2, T3N0), IIIa (T3N1, T2N2, T4N0), and IIIb (T3N2). At least 15 examined
             lymph nodes are required to ensure the adequate TNM (Tumor Nodes Metastases
             classification.

          -  Patients who underwent curative D2 lymphadenectomy resection for gastric cancer with
             no macroscopic or microscopic evidence for remaining tumor, who can be randomized to
             either study arm within 6 weeks after surgery.

        Exclusion Criteria:

          -  Pregnant or lactating women.

          -  Women of childbearing potential with either a positive or no pregnancy test at
             baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be
             considered of non-child bearing potential.

          -  Sexually active males and females (of childbearing potential) unwilling to practice
             contraception during the study.

          -  Any evidence of metastatic disease (including presence of tumor cells in the ascites).

          -  Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids,
             for the currently treated gastric cancer.

          -  Major surgery within 4 weeks prior to study treatment start, or lack of complete
             recovery from the effects of major surgery.

          -  History of another malignancy within the last five years except cured basal cell
             carcinoma of skin and cured carcinoma in-situ of uterine cervix.

          -  Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery
             disease, New York Heart Association (NYHA) grade II or greater congestive heart
             failure or serious cardiac arrhythmia requiring medication or myocardial infarction
             within the last 12 months.

          -  Lack of physical integrity of the upper gastrointestinal tract or those who have
             malabsorption syndrome likely to influence absorption of capecitabine, or inability to
             take oral medication.

          -  Known peripheral neuropathy ≥ CTCAEv3 grade 1 (Common Terminology for Adverse Events).
             Absence of deep tendon reflexes as the sole neurologic abnormality does not render the
             patient ineligible.

          -  Organ allografts requiring immunosuppressive therapy.

          -  Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant
             disease.

          -  Moderate or severe renal impairment [creatinine clearance equal to or below 50 ml/min
             (calculated according to Cockroft and Gault)], or serum creatinine > 1.5 x upper limit
             of normal (ULN).

          -  Any of the following laboratory values:

               -  Absolute neutrophil count (ANC) < 1.5 x 109/L

               -  Platelet count < 100 x 109/L

               -  Total bilirubin > 1.5 x ULN

               -  ALAT, ASAT > 2.5 x ULN

               -  Alkaline phosphatase > 2.5 x ULN.

          -  Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without
             documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known
             DPD deficiency.

          -  Hypersensitivity to platinum compounds or any of the components of the study
             medications.

          -  Received any investigational drug or agent/procedure, i.e. participation in another
             trial, within 4 weeks before randomization.

          -  Blood transfusions or growth factors to aid hematologic recovery within 2 weeks prior
             to study treatment start.

          -  Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or
             chemically related analogues, such as brivudine.

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