Venous Thromboembolism in Advanced Gastric Cancer Patients

Primary objectives - To evaluate the incidence of VTE in advanced gastric cancer with chemotherapy and to identify risk factors and biomarkers for VTE in this population

Secondary objectives

• To investigate the significant impact of VTE on overall survival and in this population

Inclusion criteria

• Histologically documented gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction
• Age 18 years or older
• Locally advanced (inoperable) or metastatic gastric cancer, initially diagnosed, recurrent gastric cancer
• Performance status (ECOG scale) : 0-2
• Adequate bone marrow function:
• Adequate renal function
• Adequate hepatic function:
• Required to be at the start of a new chemotherapy regimen
• Received chemotherapy one cycle or more
• Adequate follow-up for at least 12 weeks
• Patients should sign a written informed consent before study entry

Exclusion criteria

• Previously exposed to chemotherapy exception adjuvant or neoadjuvant therapy
• Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence
• Prior radiotherapy was administered to target lesions selected for this study, or radiotherapy to the non-target lesions has been completed within 4 weeks before randomization
• Presence of CNS metastasis
• Major surgery within 4 weeks before initiation of study treatment or lack of complete recovery from the effects of major surgery. Patient received curative operation or RFA for metastatic disease.
• Significant traumatic injury within 4 weeks prior to enrollment
• Serious illness or medical conditions, as follows:

• Congestive heart failure (NYHA class III or IV)
• Unstable angina or myocardial infarction within the past 12 months
• Significant arrhythmia requiring medication and conduction abnormality such as over 2nd degree AV block
• Uncontrolled hypertension
• Liver cirrhosis (≥ Child class B)
• Psychiatric disorder that may interfere with protocol compliance
• Unstable diabetes mellitus
• Active infection
• Superficial thrombophlebitis, transient ischemic attacks, and thrombosis occurring in setting of disseminated intravascular coagulation
• Pregnant or lactating women
• Hormonal replacement therapy within 4 weeks
• Chronic oral treatment with corticosteroid unless initiated > 6 months prior to study entry and at low dose (≤ 20mg methylprednisolone or equivalent)
• Warfarin of heparin therapy
• Not able or willing to give informed consent
• Any patients judged by the investigator to be unfit to participate in the study