Head and Neck squamous cell carcinoma Head and neck carcinoma, squamous cell carcinoma, ineligible for cisplatin treatment
Conditions
Interventions
Chemoradiotherapy with weekly carboplatin for head and neck carcinoma
D059248
carboplatin, chemoradiotherapy
Sponsors
Ueki Yushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Pathologic or cytologic diagnosis of head and neck squamous cell carcinoma treated with radical chemoradiotherapy, ie, whole-neck irradiation including bilateral levels II-IV 2)Measurable or evaluable lesions 3)Over 20 and less than 75 years with moderate renal dysfunction (over 30 and less than 60ml/min of eGFR) 4)Over 75 and less than 90 years old with over 40ml/min of eGFR 5)Performance status(PS) 0-2 6)Adequate organ functions defined as indicated below before registration in 14 days White blood cells >3,000/ mm3 Neutrophilic >1,500/mm3 Blood platelet >100,000/mm3 Total bilirubin less than 2 times as standard AST and ALT less than 2 times as standard 7)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Past history of serious drug hypersensitivity 2)Presence of other cancer 3)Clinically problematic infectious disease 4)Severe complication that might affect treatment (eg. emphysema or interstitial pneumoniae) 5) Nonradical treatment indicated 6) Continuous administration of steroid or immunosuppressant 7) Pregnant or nursing women and those with the possibility of pregnancy 8) Refusal to birth control during participation 9Mental or neurologic disease that might affect participation 10)Participation judged by physician to be inadvisable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion rate of chemoradiotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Incidense of adverse events | — |
Contacts
Public ContactYushi Ueki
Niigata University Medical & Dental Hospital
Outcome results
None listed