PREACT Study: Locally Advanced Gastric Cancer, Chemoradiotherapy vs. Chemotherapy Followed by D2 Surgery and Adjuvant Chemotherapy

Exclusion Criteria

• •Considered operable following initial staging investigations or after pre-operative therapy Disease which can be radically treated with radiotherapy to 45 Gy with standard fractionation
• •Adequate organ function defined as follows:
• •Bone marrow: Haemoglobin \>=90 g/L, Absolute neutrophil count (ANC) \>=1.5 x 109 /L, Platelet count \>=100 x 109 /L; Hepatic: Serum bilirubin \<=1.5 x upper limit of normal, aspartate aminotransferase (AST) and/or alanine transaminase (ALT) \<=2.5 x upper limit of normal; Renal: Serum creatinine \<=1.0 x upper limit of normal
• •Patients are willing to obey the treatment and provide blood and tissue specimens
• •Written informed consent obtained before randomization
• •Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures
• •Sexually active males or females refuse to practice contraception during the study until 30 days after end of study
• •Evidence of metastatic disease
• •Prior chemotherapy or radiotherapy
• •Patients with a past history of cancer in the 5 years before randomization except for the squamous or basal cell carcinoma of the skin that has been effectively treated, and carcinoma in situ of the cervix that has been treated by operation
• •Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled
• •Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease
• •Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, or congestive heart failure, or cardiac infarction within 6 months prior to study enrollment, or cardiac insufficiency
• •Concurrent severe infection
• •Severe gastrointestinal bleeding, gastrointestinal perforation
• •Unable to swallow
• •Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety
• •Known hypersensitivity reaction or metabolic disorder to S-1or oxaliplatin
• •Renal impairment (GFR \<=50ml/min)
• •Linitis plastica