Eligibility DRKS00005561 NCT00508664 Squamous Cell Carcinoma of the Hypopharynx Inclusion Criteria age 18 Years to 75 Years Yes
No
Histologically confirmed, primary only with laryngectomy respectable squamous-cell carcinoma of the larynx or hypopharynx Yes
No
T3-T4a carcinoma of the glottis Yes
No
T2-T4a carcinoma of the supraglottic, only controllable by laryngectomy and if applicable by root of tongue segmental resection Yes
No
T2-T4a carcinoma of the hypopharynx only controllable by laryngectomy (for example T2, post cricoidal) and hypopharynx segmental resection Yes
No
N-status: cervical metastases (N <=3) have to be rehabilitate by surgical procedures Yes
No
Blood count: Leukocytes >3500/mm\3, Neutrophils > 1500/ mm\3, Thrombocytes > 8000/ mm\3 Yes
No
Clinical Chemistry Finding Yes
No
adequate renal function, defined by serum creatinine and urea not >25% upper NL, creatinine-clearance > 60 ml/min/1,72 m\2 Yes
No
adequate hepatic function with SGOT, SGPT not >50% and bilirubin not >upper NL Yes
No
Electrolytes normal Yes
No
anesthetic risk normal or low-grade elevated Yes
No
age 18-75 years Yes
No
written informed consent Yes
No
effective contraception after individual advice for men and women if there is a possibility of reproductive potential (effective contraception are: oral contraception with estrogen and gestagen (no minipill), vaginal ring, contraception patch, estrogen free ovulation suppressors, hormone spiral with progesterone, injection for three month with depot gestagen, hormone releasing implantation (luteal hormone containing rod), abstinence or sterilization (vasectomy) of the male) Yes
No
Exclusion Criteria primary cancer treatable by operational larynx-conserving procedures Yes
No
distant metastases (M1-Status) Yes
No
total tumor volume exceeding 80 ml or larynx skeleton punctuated with infiltration of surrounding soft tissues respectively the esophageal aditus (exclusive cartilage infiltration represents no exclusion criteria) Yes
No
tumor-specific prior chemo- or radiotherapy Yes
No
metachronous or synchronous malignant tumor (exception basalioma) [in case of a controlled tumor of different localization with a non-treated interval over 5 years to the present therapy the patient can be included after consultation with the coordinating investigator] Yes
No
Life expectancy Yes
No
Karnofsky performance status <70% Yes
No
serious cardiopulmonary concomitant disease (cardiac insufficiency grade III and IV according NYHA status, myocardial infarction, angina pectoris, respiratory global insufficiency) Yes
No
Chronic diseases with permanent-therapy (uncontrolled diabetes, active rheumatoid arthritis) Yes
No
recurrent pneumonia, COPD GOLD stage <2, chronic inflammation of intestine or any other concomitant diseases, which disallow study participation in the opinion of the responsible physician Yes
No
Other circumstances (contra-indications), which disallow treatment with Docetaxel, Cisplatin, 5-FU, Cetuximab or radiotherapy Yes
No
Expected absent patient compliance Yes
No
Periodic follow-up not possible (for example address outside germany) Yes
No
Pregnant or breast-feeding woman Yes
No
Absent or constricted legal capacity Yes
No
Participation to another clinical trial with any investigational study within 30 days prior to study screening Yes
No
