JPRN-UMIN000009628
Completed
Phase 2
Clinical trial of postoperative chemotherapy with TS-1 in recurrent high-risk cases with oral squamous cell carcinoma - Clinical trial of postoperative chemotherapy with TS-1 in recurrent high-risk cases with oral squamous cell carcinoma
Department of Clinical Oral Oncology, Unit of Translational Medicine, Nagasaki University Graduate School of Biomedical Sciences0 sites90 target enrollmentDecember 25, 2012
ConditionsOral squamous cell carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Oral squamous cell carcinoma
- Sponsor
- Department of Clinical Oral Oncology, Unit of Translational Medicine, Nagasaki University Graduate School of Biomedical Sciences
- Enrollment
- 90
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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