Randomized Phase II trial of TS-1 based thrapy vs TS-1 based therapy + LNT for advanced or Recurrent Gastric Cancer
- Conditions
- Inoperable or Recurrent Gastric Cancer
- Registration Number
- JPRN-UMIN000003156
- Lead Sponsor
- Hiroshima University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method