XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of Stomach

Recruitment & Eligibility

Inclusion Criteria

Ages Eligible for Study: 65 Years or older
Genders Eligible for Study: Both
The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
Histologically confirmed gastric adenocarcinoma(including LAUREN type).
Measurable disease(according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1).
chemotherapy naive after recurrence or metastasis. Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months.
Hb > 90g/L, neutrophil count > or = 1.5*10^9/L, platelet > or = 100*10^9/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upper limit of nominal (ULN), alkaline phosphatase (ALP) < or = 2.5 times ULN, total bilirubin (TBIL) < 1.5 times ULN, serum albumin level > or = 30g/L, serum creatinine < 1 times ULN.
No serious concomitant diseases which could lead to death within 5 years. At least 5 years from the last Biological/Immunotherapy/Hormone treatment for Malignancy excluding gastric cancer.
Able to accept oral medication
Compliance with protocol

Exclusion Criteria

Had received cytotoxic chemotherapy, radiotherapy or immunotherapy for this gastric cancer, excluding Corticosteroids.
Other previous malignancy within 5 year, except curative skin cancer or carcinoma in situ of uterine cervix.
Uncontrolled epilepsy, central nervous system disorders, or a history of mental disorders.
clinically significant(i.e. active)cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) II or more serious congestive heart failure or severe requiring medication intervention arrhythmia, or history of myocardial infarction within the last 12 months.
Upper gastrointestinal obstruction or physiological dysfunction or suffering from malabsorption syndrome, which could affect the absorption of capecitabine.
Organ transplantation requires immunosuppressive treatment.
Severe uncontrolled recurrent infections, or Other serious uncontrolled concomitant diseases.
Moderate or severe renal impairment(creatinine clearance (CCr) = or < 50 ml/min), or serum creatinine > ULN.
Known enzyme deficiency of dihydropyrimidine dehydrogenase(DPD).
Allergy to Oxaliplatin or any study medication ingredients.

Study & Design

Arm && Interventions

Group	Intervention	Description
XELOX-X	Oxaliplatin	XELOX: Oxaliplatin: 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine: 850mg/m\^2 bid, days 1-14, every 3 weeks and maximum 4 cycles, or progression/intolerance. X Maintenance: Capecitabine 850mg/m\^2 bid, days 1-14, every 3 weeks after 4 cycles XELOX regimen, until progression/intolerance.
XELOX-X	Capecitabine	XELOX: Oxaliplatin: 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine: 850mg/m\^2 bid, days 1-14, every 3 weeks and maximum 4 cycles, or progression/intolerance. X Maintenance: Capecitabine 850mg/m\^2 bid, days 1-14, every 3 weeks after 4 cycles XELOX regimen, until progression/intolerance.
XELOX	Oxaliplatin	XELOX: Oxaliplatin 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine 850mg/m\^2 bid, days 1-14, every 3 weeks, until progression/intolerance.
XELOX	Capecitabine	XELOX: Oxaliplatin 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine 850mg/m\^2 bid, days 1-14, every 3 weeks, until progression/intolerance.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Secondary Outcome Measures

Name	Time	Method
overall survival (OS)	from the date of randomization until death from any cause or up to 1 year
Response Rate (RR)	evaluate every 6 weeks after the date of randomization until diease progress or up to 12 weeks
adverse events (AE)	from date of randomization to 28 days after the last chemo dosage

Recruitment & Eligibility