Feasibility study evaluating Paclitaxel, Carboplatin and Cetuximab (PCE) as induction chemotherapy followed by chemoradiation in patients with Unresectable Locally advanced Squamous Cell Carcinoma of the Head and Neck
- Conditions
- Head and Neck cancer
- Registration Number
- JPRN-UMIN000014430
- Lead Sponsor
- IC-PCE study executive committee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 34
Not provided
1)Primary lesion located at the nasopharynx, oral cavity, nasal cavity, parasinus or salivary gland. 2)Prior RT, CT or endocrine therapy for the current or any other malignancy . 3)Current other synchronous primary double cancers and metachronous double cancers unless free of disease for at least five years (excluding superficial cancer that will be cured by endoscopic mucosal resection). 4)Severe myelosuppressifon or infection. 5)Pulmonary fibrosis, acute lung injury or Intestinal pneumonia . 7)Active gastrointestinal bleeding. 8)Clinically relevant comorbidity included heart failure, renal failure, liver failure, uncontrolled hypertension or uncontrolled diabetes mellitus. 9)History of severe hypersensitivity. 10)Known hypersensitivity against any components of the trial treatment including excepients. 11)Pregnancy or breast feeding. 12)Current administration of disulfiram, Cyanamide, Carmofur or procarbazine hydrochloride. 13)Previous treatment with cetuximab or monoclonal antibody. 14)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 Proportion of chemoradiation completion
- Secondary Outcome Measures
Name Time Method Response rate, Frequency and types of adverse events, Time-to-local progression, Time-to-distant metastasis, Event-free survival, Overall survival