ECRIPS: Phase II study of docetaxel, cisplatin and cetuximab (TPE) followed by cetuximab with Concurrent Radiotherapy in Patients with local advanced Squamous cell carcinoma of the Head and Neck (LA-SCCHN).
- Conditions
- Head and Neck cancer
- Registration Number
- JPRN-UMIN000009928
- Lead Sponsor
- CSPOR-HN 01 executive committee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 55
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method