advanced/metastatic gastric cancer
Conditions
Interventions
Drug : S-1+DTX S-1 : 80mg/m2/day po on Days 1-14, 7 days rest DTX : 40mg/m2 div on Day 1
Drug : S-1+CDDP S-1 : 80mg/m2/day po on Days 1-21, 14days rest CDDP : 60mg/m2/day div on Day 8
Sponsors
Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)proven gastric cancer histologically 2)patients with gastric cancer who cannnot undergo D0 resection or patients who have undergone R1/2 resection, or patients with metastatic gastric cancer without any prior chemotherapy 3)without any mesurable lesions by RECIST(ver 1.1)(*) *non lymph node tumors more than 10mm in long diameter by under 5mm slice CT or over 2 times of slice width by more wider slice CT *more than 15mm in short diameter by under 5mm slice CT 4)patients who can eat orally without severe peritoneal metastases(*) *ascites both in upper abdomen and lower abdomen by CT *patients who received extraction of ascites to reduce symptoms less than 14 days before registration *complete ileus clinically 5)HER2(-) or unknown HER2 6)without active bleeding from original tumor 7)without brain metastases 8)without any prior chemotherapy and/or radiationtherapy 9)patients between 20 and 75 years old 10)PS(ECOG) between 0 and 2 11)with a good condition of important organs 1.WBC : >= 3,000/mm3 and <= 12,000/mm3 2.neutrophil >= 2,000/mm3 3.platelet >= 100,000/mm3 4.hemoglobin >= 9.0g/dL 5.ALT/AST <= 100IU/L 6.total bilirubin <= 1.5mg/dL 7.serum creatinine <= 1.2mg/dL 8.Creatinine clearance >= 60mL/min 12)expected survival longer than 3 months 13)written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1)with active double cancer (*) *Simultaneous double cancer or sequential double cancer whose rest is shorter than 5 years. Carcinoma in situ or cancers localized in membranous layer are not included to double cancer. 2)with positive HBs 3)with uncontrolled heart diseases (congention heart failure) or unstable angina pectoris, or with a history of cardiac infarction within 6 months 4)with uncontrolled DM or hypertension 5)with interestitial pneumonitis or pulmonary fibrosis 6)women pregnant and/or nursing or women who like to be pregnant or males who like to have their own baby 7)with other diseases which disturb the course of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival : OS | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival : PFS Incidence of Advers Events | — |
Countries
Japan
Contacts
Public ContactHirosh Furukawa
Kinki University School of Medicine Department of surgery
Outcome results
None listed