Phase I/II Trial of S-1 and Nedaplatin with concurrent radiotherapy in locally advanced mesopharynx, hypopharynx cancer
- Conditions
- Mesopharyngeal cancer Hypopharyngeal Cancer
- Registration Number
- JPRN-UMIN000003889
- Lead Sponsor
- Kitasato University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 43
Not provided
1)active double cancer 2)severe complications (congested heart failure, coronary insufficiency, myocardial infarction, angina pectoris or abnormal cardiac rhythm which need to treat, history of cerebrovascular accident, hemorrhagic gastrointestinal ulceration, uncontrolled diabetes, renal failure, active hepatitis, liver cirrhosis) 3)develop fever and suspected infection 4)motor palsy, peripheral neuropathy or edema (exclude the disorder which derives from primary disease) 5)pleural effusion which need to treat or pericardial effusions 6)pregnant or nursing women or women who like be pregnant and men with partner willing to get pregnant 7)interstitial pneumonitis which is revealed from chest X ray and chest CT 8)history of mental disorder or treating it at the moment 9)history of severe allergy 10)severe allergy to S-1 or Nedaplatin 11)patients receiving 5-FU based chemotherapy 12)patients receiving Flucytosine 13)doctors decision not to be registered to this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: To determinate maximum tolerated dose and recommended dose Phase II: complete response rate
- Secondary Outcome Measures
Name Time Method Phase I: safety Phase II: response rate, time to laryngeal preservation, local control rate, relapse free survival, overall survival, safety, time to treatment failure, QO