Recurrent/metastatic squamous cell carcinoma of the head and neck
Conditions
Interventions
S-1 is administered orally twice a day at a dose of 40-60 mg (80-120 mg/day) for 14 days, followed by 7 days rest. Cetuximab is administered intravenously once a week at a dose of 400mg/m2 for the fir
Sponsors
Hokkaido University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Inoperable recurrent/metastatic head and neck cancer (2)Inappropriate for definitive radiotherapy (3)Histologically or cytologically proven squamous cell carcinoma (4)Age >=20 at the time of registration (5)ECOG performance status 0-2 (6)Inappropriate for platinum-based thrapy for any of the following reasons: Age >=20, <70 and PS 2 Age >=70, <75 and PS 1-2 Age >=75 and PS 0-2 Complications Refusal of platinum-based therapy (7)Measurable lesion (8)No prior chemotherapy after diagnosis of recurrence or metastasis, excluding immune checkpoint inbibitor (9)Adequate organ functions: Neutrophil >=1,500 /mm3 Platelet >=100,000 /mm3 Hemoglobin concentration >=8.0 g/dl AST or ALT <=100 U/L (<=200 U/L case with liver metastasis) T-bilirubin <=1.5 mg/dl Creatinin clearance >=40 ml/min (10)Life expectancy of more than 3 months (11)Written informed consent
Exclusion criteria
Exclusion criteria: (1)History of severe hypersensitivity (2)Active infection (3)Severe and uncontrolled complication(severe heart failure, cerebrovascular disease, pulmonary fibrosis, renal failure, liver failure, active peptic ulcer, uncontrolled diabetes mellitus, uncontrolled hypertention, etc.) (4)Uncontrolled pleural, pericardial effusion or ascites (5)Symptomatic brain metastasis (6)Simultaneous or metachronous double cancers within the past 5 years other than skin cancer (malignant melanoma is excluded), carcinoma in situ of uterine cervix and mucosal carcinoma of digestive tract (7)Receiving flucytocine (8)HBs Ag positive (9)Pregnant or lactating women or women of childbearing potential and men in hope of the pregnancy of the partner (10)Unstable psychiatric disease (11)Surgery or radiotherapy within 4 weeks (12)Decision of ineligibility by a physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate, progression free survival, overall survival, time to treatment failure, dose intensity, safety | — |
Countries
Japan
Contacts
Public ContactJun Taguchi
Hokkaido University Faculty of Medicine and Graduate School of Medicine Department of medical oncology
Outcome results
None listed