Advanced or recurrent gastric cancer
Conditions
Interventions
TS-1 is administered orally at Monday, Wednesday, Friday and Sunday. Lentinan is administered intravenousely once a week.
Sponsors
Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically demonstrated adenocarcinoma of advanced or recurrent gastric carcinoma. 2) Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors. (RECIST) 3) No prior radiotherapy, chemotherapy or hormone therapy. 4) Adequate organ functions: i) WBC >=3000/mm3 and <=12000/mm3, ii) neutrophils >=2000/mm3, iii) platelets >=100,000/mm3, iv) hemoglobin >=8.0g/dL, v) total bilirubin <=1.5mg/dL, vi) AST(GOT)/ALT(GPT) <=100IU/L, vii) creatinine clearance >=50mL/min. 5) ECOG Performance status:0-2 6) Expected survival over 3 months. 7) Age of 20 years or older. 8) Sufficient oral intake. 9) Normal ECG. 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Limitation of use of TS-1. 2) Infection and inflammation. 3) Serious heart disease. 4) Symptomatic pulmonary fibrosis or interstitial pneumonia. 5) Severe complications, such as ileus, uncontrolled diabetes mellitus, heart failure, renal failure and hepatocirrhosis. 6) A large amount of pleural effusion or peritoneal fluid. 7) Widespread bone-marrow metastases. 8) Brain metastasis. 9) Fresh bleeding from digestive organs. 10) Diarrhea. 11) Severe mental disorders. 12) Active synchronous malignancy. 13) Patients under treatment with flucytosine, phenytoin or warfarin potassium. 14) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 15) Other patients who are unfit for the study as determined by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Treatment Failure | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, Progression Free Survival, Response Rate, Adverse Effect, Quality of Life | — |
Countries
Japan
Contacts
Public ContactShigefumi Yoshino
Yamaguchi University Graduate School of Medicine Department of Digestive Surgery and Surgical Oncology
Outcome results
None listed