Phase II study of daily administration of TS-1 plus lentinan(LNT) in advanced or recurrent gastric cancer.
- Conditions
- Advanced or recurrent gastric cancer
- Registration Number
- JPRN-UMIN000008590
- Lead Sponsor
- Department of Digestive Surgery and Surgical Oncology, Yamaguchi University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Treatment Failure
- Secondary Outcome Measures
Name Time Method Overall Survival, Progression Free Survival, Response Rate, Adverse Effect, Quality of Life