Mesopharyngeal cancer Hypopharyngeal Cancer
Conditions
Interventions
Combination chemotherapy consists of TS-1 (80-120 mg/day, day 1 through 14, day 29 through 42), Nedaplatin (80-100 mg/m2, day 1 and day 29). A total radiation dose of 60 Gy is planned with conventiona
Sponsors
Kitasato University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)histologically or cytologically confirmed squamous cell carcinoma 2)stage II-IVA mesopharunx, and hypopharynx cancer 3)age: >=20 and <80 4)with measurable region 5)without prior radical surgery 6)without prior treatment 7)Performance Statues: 0-1(ECOG) 8)sufficient function of important organs a)WBC: >=3,500/mm3 and <=12,000/mm3 b)Neutrophyl: >=2,000/mm3 c)Platelet: >=100,000/mm3 d)Hemoglobin: >=10g/dl e)GOT, GPT: <= 2.0 times of the upper limit of normal range in each institute f)ALP: <= 2.0 times of the upper limit of normal range in each institute g)sT.bil: <= 1.5 times of the upper limit of normal range in each institute h)sCreatinin: <= the upper limit of normal range in each institute i)Ccr: >=60 ml/min/body 9)expected more than 3 months survival from drug administration 10)written informed consent 11)with ability of oral intake
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: To determinate maximum tolerated dose and recommended dose Phase II: complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: safety Phase II: response rate, time to laryngeal preservation, local control rate, relapse free survival, overall survival, safety, time to treatment failure, QOL | — |
Countries
Japan
Contacts
Public ContactKoichi Kano
Kitasato University School of Medicine Department of Otorhinolaryngology
Outcome results
None listed