Gastric Cancer
Conditions
Interventions
Treatment should be started within 2 weeks of registration Nab-paclitaxel (220mg/m2) is administered intravenously in 30 minutes once 21 days. When neutrophil keeps more than 1500/mm3, the dose of Na
Sponsors
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven gastric adenocarcinoma including esophago-gastric injection cancer 2) Patient with adevanced/recurrent gastric cancer which are resistant to chemotherapy including fluoropyrimydine. Patient with HER2 positive have to use trastuzumab in combination with fluoropyrimydine. 3) Older than 20 years 4) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2. 5) With mesurable lesions by RECIST version 1.1 6) Without prior therapy of paclitaxel 7) With good functions of important organs a) WBC : =< 12,000/mm3 b) Neutrophil : => 2,000/mm3 c) Platelet : => 100,000/mm3 d) Hemoglobin : => 9.0g/dL e) Total bilirubin : =< 1.5mg/dL f) AST, ALT : =< 100IU/L, or =< 200IU/L for patients with liver metastasis g) Creatinine : =< 1.5mg/dL 8) With longer than 90 days of expected survival at the registration 9) With written Informed Consent
Exclusion criteria
Exclusion criteria: 1)with a history of severe allergy against medicine 2)with infectious disease and febrile condition (over 38 centigrade) 3)with severe diseases: interstitial pneumonitis/pulmonary fibrosis, uncontrolled DM, renal failure, and/or liver failure 4)with uncontrollable diarrhea (more than 4 times a day) 5)with a history or present heart diseases (congestive heart failure, cardiac infarction/ischemic heart disease, arrhythmia, valve dysfunction) 6)with active double cancers excluding carcinoma in situ and/or prior cancer cured with longer than 5 year interval period 7)with peripheral nerve disorder severer than grade 2 8)patients who are suspected incompletion of regimen due to psychological disease 9) pregnant or nursing female or male expecting pregnancy of partner 10) with brain metastasis 11) with HBs antigen+, and/or HCV-antibody+ 12) Any other patients whom the physician in charge of the study judges to be unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival rate Progression free survival rate Time to treatment failure Disease control rate Incidence and Grade of Adverse Events Relative Performance Rate of Patients who receive next treatment | — |
Countries
Japan
Contacts
Public ContactHirokazu Taniguchi
Minoh City Hospital Department of Surgery
Outcome results
None listed