Clinical trial of postoperative chemotherapy with TS-1 in recurrent high-risk cases with oral squamous cell carcinoma
- Conditions
- Oral squamous cell carcinoma
- Registration Number
- JPRN-UMIN000009628
- Lead Sponsor
- Department of Clinical Oral Oncology, Unit of Translational Medicine, Nagasaki University Graduate School of Biomedical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Not provided
1) Simultaneous or metachronous (within 5 years) double cancers 2) Administration contraindication of TS-1 3) Serious postoperative complications 4) Watery diarrhea 5) One or more of following comorbid disorder Poor controlled diabetes, poor controlled hypertension, hepatic cirrhosis, hepatic insufficiency, renal failure, interstitial pneumonia, fibroid lung, severe pulmonary emphysema, active infectious disease, heart failure for not more than 6 months, cardiac infarction, severe aberration of electrocardiogram 6) Pleural effusion, pericardiac effusion, or ascites to be drained. 7) Continuous flucytosine, phenytoin, and warfarin potassium treatment 8) Severe drug allergy 9) Psychiatric disease 10) Women during pregnancy, possible pregnancy, or breast-feeding 11) Men with making pregnant 12) Cases judged to be inappropriate by attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-free survival
- Secondary Outcome Measures
Name Time Method 1) Overall survival 2) Relapse-free survival 3) Local relapse-free survival 4) Proportion of treatment completion