Local advanced squamous cell carcinoma of the Head and Neck
Conditions
Interventions
5FU was administered by continuous infusion on days 1-5.The cycle was repeated every 4 weeks. Docetaxel was infused over 60 min on days 1 and 15.The cycle was repeated every 4 weeks. Nedaplatin was
Sponsors
Kindai nara hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study were aged 20-75 years at the time of registration and were histologically or cytologically confirmed to have local advanced cancer with SCC. Inclusion criteria also included an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy of >12 weeks, as well as adequate liver, bone marrow, renal, and cardiovascular functions, as evidenced by the following measures: serum aspartate aminotransferase and alanine aminotransferase levels of less than or equal to twice the upper limit of normal range; platelet count. The presence of measurable disease was not a requirement to participate in this study.
Exclusion criteria
Exclusion criteria: The major exclusion criteria were as follows: previous treatment with cis-dichlorodiammineplatinum (II) (CDDP), 5-FU, and/or taxane therapy for recurrent disease or irradiation to major bone areas; serious concomitant malignancy; active infectious disease with fever; severe drug allergy; symptomatic peripheral neuropathy; uncontrolled diabetes mellitus, hypertension, angina pectoris, arrhythmia, or congestive heart failure; and interstitial pneumonia or lung fibrosis. Prior to study entry, all patients were required to sign an informed consent form approved by the Ethical Committee of Kinki University Hospital.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total treatment rate | — |
Secondary
| Measure | Time frame |
|---|---|
| response, advance events, PFS, OS | — |
Countries
Japan
Contacts
Public Contactshinya ueda
kindai nara hospital medical oncology
Outcome results
None listed