A Randomized Single Center Controlled Study to Compare Perioperative Chemotherapy of Oxaliplatin Combined With Capecitabine (XELOX) Versus XELOX as Post-operative Chemotherapy in Advanced Gastric Adenocarcinoma With D2 Dissection
- Karnofsky performance status of ≥60 %.
- Histologically confirmed gastric adenocarcinoma, staged pathologically or clinically,
stage cT2-4N+M0, and cT4N0M0.
- Patients had to have adequate renal function (serum creatinine ≤1 times the upper
limit of normal [ULN]), hepatic function (total bilirubin ≤1·5 times the ULN,
aspartate or alanine aminotransferase ≤2·5 times the ULN, alkaline phosphatase ≤2·5
times the ULN, Serum albumin ≥30g/L), and haematological function (absolute
neutrophil count ≥1·5×10⁹/L and platelet count ≥100×10⁹/L)
- Pregnant or lactating women.
- According to the AJCC TMN 7.0, Any evidence of metastatic (TxNxM1) patients(including
presence of tumor cells in the ascites).
- Sexually active males and females (of childbearing potential) unwilling to practice
contraception during the study.
- Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except
corticosteroids, for the currently treated gastric cancer.
- Has uncontrolled epilepsy, central nervous system diseases or mental disorders of
- 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
- 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
- Hypersensitivity to platinum compounds or any of the components of the study
- Received any investigational drug or agent/procedure, i.e. participation in another
trial, within 4 weeks before randomization.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.