Inoperable or Recurrent Gastric Cancer
Conditions
Interventions
TS-1 based therapy
TS-1 based therapy + LNT
Sponsors
Hiroshima University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven advaneced or recurrent gastric cancer gastric adenocarcinoma. 2) No previous treatment other than chemotherapy or surgery. 3) ECOG Performance Status 0-2 4) Age > 20 years old 5) Life expectancy over 3 months 6) Adequate organ function for enrollment before 14 days. 7) Measurable lesions according to RECIST guidelines. 8)Sufficient oral in 9) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Drug hypersensitivity or severe drug allergy. 2) With infectious disease which needs treatment. 3) Uncontrolled medical conditions (e.g., congestive heart failure, ileus, interstitial pneumonia, pulmonary fibrosis, diabetes, interstitial pneumonia, pulmonary fibrosis, renal failure). 4) Patients with severe dysfunction of bone marrow 5) Patients with severe dysfunction of liver 6) Patients who need flucitosine 7) With uncontrolled pleural effusion or ascites. 8) Patients with any symptoms due to metastases to the central nervous system 9) Active concomitant malignancy. 10) Pregnant or lactating women 11) men with intent to bear baby 12) Any other patient whom the physician in charge of the study judges to be not eligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint : Time to Treatment Failure(TTF) Secondary Endpoint : Overall Survival(OS), Progression Free Survival(PFS), Quality of Life(QOL), Response Rate(RR), Safety, Compliance | — |
Countries
Japan
Contacts
Public ContactKazuaki Tanabe
Hiroshima University Hospital gastrointestinal surgery
Outcome results
None listed