Head and Neck cancer
Conditions
Interventions
Docetaxel+CDDP+ Cetuximab followed by Cetuximab+RT
Sponsors
CSPOR-HN 01 executive committee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically diagnosed primary squamous cell carcinoma Primary lesion located in the mesopharynx, hypopharynx, or larynx Resectable LA-SCCHN diagnosed within 4 weeks before enrollment Age between 20 and 75 years ECOG PS 0 or 1 No prior curative surgery for head and neck cancer, excluding diagnostic biopsy of cervical lymph nodes No prior RT, CT or endocrine therapy for the current or any other malignancy Maintenance of vital organ functions, as indicated by the following laboratory data obtained within 14 days before enrollment Written informed consent to the study signed by the patient
Exclusion criteria
Exclusion criteria: 1) Evidence of distant metastasis. 2) Post-operative RT is intended. 3) Pregnancy or breastfeeding. 4) Prior therapy with Cetuximab or monoclonal antibody. 5) Medical or psychiatric condition that would not permit the subject to complete the trial or informed consent. 6) Uncontrollable diabetes or malignant hypertension or liver failure. 7) History of Pulmonary fibrosis, acute lung injury or interstitial pneumonia. 8) Active infection. Known HIV. 9) Known coronary artery disease, history of myocardial infarction within prior 12 months, uncontrollable arrhythmia, or uncontrollable cardiac failure. 10) Dental treatment with incision and drainage. 11) History of multiple cancers unless free of disease for at least three years. 12) Patient judged inappropriate for this trial by physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of treatment completion | — |
Secondary
| Measure | Time frame |
|---|---|
| larynx function preservation, response rate, local progression-free survival, overall survival, progression-free survival, Safety | — |
Countries
Japan
Contacts
Public ContactAkira Yamao
Public health research foundation Executive office of Comprehensive Support Project for Oncology Research
Outcome results
None listed