Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) in Patients With Advanced Gastric Cancer
Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) in Patients With Advanced Gastric Cancer
In China, S-1 is an novel oral fluoropyrimidine with demonstrated high efficacy on
 gastrointestinal cancer. The new regimen with oxaliplatin and leucovorin is expected to
 achieve more encouraging efficacy on gastric cancer. This study is aimed to evaluate the
 feasibility of the SOL regimen on efficacy and tolerability on Chinese patients with advanced
 gastric cancer.
Inclusion Criteria:

 -  Age over 18 years old

 -  Histologically or cytologically documented gastric adenocarcinoma

 -  Performance status (ECOG scale): 0-2

 -  Life expectancy ≥ 3 months

 -  No previous treatment(including: radiotherapy,chemotherapy and immunotherapy)

 -  Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive
 immunotherapy) for adjuvant or neoadjuvant treatment for non-metastatic (M0) disease
 has been completed within 6 months prior to initiation of study treatment.

 -  WIth Measurable Target lesion

 -  Patients should sign a written informed consent before study entry

 Exclusion Criteria:

 -  History of hypersensitivity to fluoropyrimidines, S-1, oxaliplatin or the ingredients
 product

 -  Inadequate hematopoietic function: WBC≦5,000/mm3; ANC≦2,000/mm3; Platelet≦100,000/mm3

 -  Inadequate organ function which is defined as below:

 Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal
 range (ULN) (>5.0 x ULN if hepatic metastasis); serum creatinine > 2 upper limit of normal
 range (ULN);

 -  Symptomatic peripheral neuropathy ≥ NCI CTC AE grade 1;

 -  Receiving a concomitant treatment with other fluoropyrimidines or fluorocytosine;

 -  Pregnancy or lactation women, or women with suspected pregnancy or men unless using a
 reliable and appropriate contraceptive method;

 -  Mental status is not fit for chemotherapy therapy presence of serious concomitant
 illness which might be aggravated by study medication;

 -  History of ventricular arrhythmia or congestive heart failure;

 -  Active cardiac disease e.g. decompensate myocardial infarction within the 6-month
 period preceding entry into the study;

 -  Significant co-morbid medical conditions, including, but not limited to, Chronic
 obstructive pulmonary disease, interstitial pneumonia ,pulmonary heart failure, renal
 failure, hepatic failure, haemorrhagic peptic ulcer, mechanical, paralytic or poor
 control diabetes