Clinical trial of concurrent chemoradiotherapy (CCRT) with S-1 in patients with advanced head and neck squamous cell carcinoma, who is not eligible for CCRT with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) regime
- Conditions
- advanced head and neck squamous cell carcinoma
- Registration Number
- JPRN-UMIN000021870
- Lead Sponsor
- Yokohama City University hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Not provided
1. with active double cancer 2. with sever complications (for example ; malignant hypertension, congested heart failure, coronary insufficiency, myocardial infarction, angina pectoris, or abnormal cardiac rhythm which need to treat within 6 months, cerebrovascular accident within 6 months, cirrhosis, hemorrhagic gastrointestinal ulceration, diabetes that is loss of control, bleeding tendency) 3. with deverop fever and suspected infection 4. with motor palsy, peripheral neuropathy or edema (exclude the disorder which derives from primary disease) 5. with pleural effusion which need to treat or pericardial effusions 6. pregnant or nursing women or women who like be pregnant 7. with interstitial pneumonitis which is revealed from chest X ray or chest CT 8. with a history of mental disorder or treated it at the momen 9. with a history of sever drug allergy 10. with sever allergy to S-1 11. during any treatment with other pyrimidine analogue drug 12. during any treatment with Flucytosine 13. Physician concludes that the patient's participation in this trial is inappropriate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival rate
- Secondary Outcome Measures
Name Time Method Response rate, treatment completion rate, Cause specific survival rate, Overall survival period, Safety