Recurrence or Metastatic Squamous cell carcinoma of the Head and Neck
Conditions
Interventions
Nedaplatin+S-1+Cetuximab
Sponsors
Kinki University Faculty of Medicine, Department of Medical Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically diagnosed primary squamous cell carcinoma Primary lesion located in the oral, nasopharynx, mesopharynx, hypopharynx, or larynx Measurable disease according to RECIST ver1.1 Age older than 20 ECOG PS 0 or 1 Not amenable for local treatment for recurrent/ metastatic disease No prior chemotherapy including nedaplatin for the current malignancy Adequate organ function Life expectancy of greater than 3 months Women of child-bearing potential and men who are able to father a child agree with using adequate contraception Written informed consent to the study signed by the patient
Exclusion criteria
Exclusion criteria: Prior systemic chemotherapy or radiotherapy which was completed more than 2 weeks prior to registration Current administration of Flucytosine Treated continuously with systemic steroids With history of severe drug allergy Massive pleural or pericardial effusion, ascites Known coronary artery disease, history of myocardial infarction within prior 6 Prior systemic chemotherapy or radiotherapy which was completed more than 2 weeks prior to registration Current administration of Flucytosine Treated continuously with systemic steroids With history of severe drug allergy Massive pleural or pericardial effusion, ascites Known coronary artery disease, history of myocardial infarction within prior 6 months or uncontrollable hypertension known cerebrovasucular disease within 6 months Active infection Continuous diarrhea Ileus or sub-ileus History of multiple cancers unless free of disease for at least five years Severe diabetes Positivity for hepatitis B surface antigen Severe psychotic disorder Pregnancy or breast feeding Other significant disease that in the investigator's opinion would exclude the subject from the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event, proportion of treatment completion, progression-free survival, overall survival, clinical utility | — |
Countries
Japan
Contacts
Public ContactTakayuki Takahama, Kaoru Tanaka
Kinki University Faculty of Medicine Department of Medical Oncology
Outcome results
None listed