advanced advanced for gastric cancer patients with prior chemotherapy
Conditions
Interventions
Nab paclitaxel(100mg/m2 day1,8,15) every 4 weeks
Sponsors
Toho University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with gastric cancer by histological or cytological examination. 2)The case that radical operation is enforced 3)Patients with prior on chemothrapy. (including recurrence within 6 months after last adjuvant chemotherapy) 4)20 years old or more 5)ECOG performance status<=2 6)More than 2 weeks last chemotherapy 7)Patients with adequately maintained organ functions and fulfilling the following conditions within 21 days before registration WBC count more than 3,000/mm3 less than , 12,000 /mm3 Neutrophils count more than 1,500/mm3 Hemoglobin more than 8.0 g/dl Platelet count more than 100,000/mm3 Serum bilirubin level less than 1.5mg/dl AST and ALT less than 2.5times 8)Patients who provided written informed consent. 9)Patients expected to survive for 90 more than days
Exclusion criteria
Exclusion criteria: 1)patients previously treated with Nab-paclitaxel,paclitaxel derivative drugs 2)peripheral neuropathy 3)History of serious drug hypersensitivity 4)active synchronous malignancy with longer than 5 year interval period 5)Uncontrolled unstable angina, congestive heart failure, myocardial infarction or ventricular arrhythmia 6)Any other serious illness or medical conditions including interstitial pneumonia or pulmonary fibrosis, renal failure, liver failure,cerebrovascular disordar or Uncontrolled diabates 7)Active infection or fever suspicious of infection. 8)The case that uses a steroid regularly 9)Much amount of pleural effusion, ascites or cardiac effusion 10)Case having extensive bone metastasis 11)with brain metastasis 12)History of mental disorder, central nerve disorder 13)Pregnant women, nursing mothers 14)Patients who were considered by the primary care physician to be inappropriate for this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate Disease Contorol Rate Overall Survival Incidence and grade of Adverse Event, | — |
Countries
Japan
Contacts
Public ContactHideaki Shimada
Toho University school of Medicine Division of General and Gastroenterological Surgery, Department of Surgery (Omori)
Outcome results
None listed