Phase II trial of Nedaplatin/S-1/Cetuximab combination therapy for Recurrence or Metastatic Squamous cell carcinoma of the Head and Neck
- Conditions
- Recurrence or Metastatic Squamous cell carcinoma of the Head and Neck
- Registration Number
- JPRN-UMIN000011497
- Lead Sponsor
- Kinki University Faculty of Medicine, Department of Medical Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method Adverse event, proportion of treatment completion, progression-free survival, overall survival, clinical utility