recurrent gastric cancer
Conditions
Interventions
Group A TS-1 + CDDP (SP) 3 weeks followd by 2 weeks rest
Group B Capecitabine + CDDP (XP) 2 weeks followd by 1 week rest
Sponsors
Osaka Gastrointestinal cancer chemotherapy Study Group(OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with metastatic lesions after R0 surgery plus TS-1 therapy recommended based on guide line 3rd edition. 1) HER2(-) or unknown adenocarcinoma on stomach 2) with diagnosis of metastatic lesions after more than 8 weeks of TS-1 administration and more than 6 months rast 3) patients 20 years of age and older 4) PS (ECOG) between 0 and 2 5) without prior chemotherapy and/or radiation therapy 6) with a dood condition of important organs within 14 days of registration 1.WBC >= 3,000/mm3 2.neutrophil >= 1,500/mm3 3.platelet >= 100,000/mm3 4.hemoglobin >= 8.0g/dL 5.AST/ALT <= 100IU/L , <=150 IU/L for patients with liver metastasis 6.total bilirubin <= 1.5mg/dL 7.serum creatinine <= 1.2mg/dL 8.creatinine clearance >=60mL/min , CC by Cockcroft-Gault method is available 7) expected survival longer than 3 months 8) patients who can eat orally 9) written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1) patients administrated fluoropyrimidine before less than 6 months of the registration 2) with a history of over 120mg/m2 dose platinum administrarion 3) with radiation therapy after recurrence 4) with active double cancers whose disease free period is shorter than 5 years 5) with brain metastasis and symptoms on brain 6) with a histoyr of severe allergy against medicines 7) with other disease 1.uncontrolled DM 2.uncontrolled hypertension 3.liver cirrhosis or liver dysfunction 4.renal failure 5.interstitial pneumonitis, pulmonary fibrosis or severe emphysema 6.active infection disease 7.cardiac failure, cardiac infarction, angina pectoris, and/or remarkable ECG change 8) with HBs (+) 9) severe diarrhea (more than 4 times/ day or watery stool) 10) patients whom administrated Flucitosine, Fenitoin and/or Warfarin 11) women who are pregnant or expect to be pregnant, or males who expect to have children 12) patients whom doctor in chief deciders not to register to this study due to psychological disease or symptom 13) patients whom doctor in chief deciders not to register to this study due to the other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival : OS | — |
Secondary
| Measure | Time frame |
|---|---|
| Responce rate (RR) Prgression-free survival : PFS Time to treatment failure : TTF Incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactHiroshi Furukawa
Kinki University School of Medicine Department of surgery
Outcome results
None listed