Description:

ODM derived from http://clinicaltrials.gov/show/NCT00508664

Link:

http://clinicaltrials.gov/show/NCT00508664

Keywords:
Versions (2) ▾
  1. 12/10/13
  2. 4/14/14
Uploaded on:

April 14, 2014

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License:
Creative Commons BY 4.0
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Eligibility DRKS00005561 NCT00508664 Squamous Cell Carcinoma of the Hypopharynx

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age 18 Years to 75 Years
Histologically confirmed, primary only with laryngectomy respectable squamous-cell carcinoma of the larynx or hypopharynx
T3-T4a carcinoma of the glottis
T2-T4a carcinoma of the supraglottic, only controllable by laryngectomy and if applicable by root of tongue segmental resection
T2-T4a carcinoma of the hypopharynx only controllable by laryngectomy (for example T2, post cricoidal) and hypopharynx segmental resection
N-status: cervical metastases (N <=3) have to be rehabilitate by surgical procedures
Blood count: Leukocytes >3500/mm\3, Neutrophils > 1500/ mm\3, Thrombocytes > 8000/ mm\3
Clinical Chemistry Finding
adequate renal function, defined by serum creatinine and urea not >25% upper NL, creatinine-clearance > 60 ml/min/1,72 m\2
adequate hepatic function with SGOT, SGPT not >50% and bilirubin not >upper NL
Electrolytes normal
anesthetic risk normal or low-grade elevated
age 18-75 years
written informed consent
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)
Exclusion Criteria
primary cancer treatable by operational larynx-conserving procedures
distant metastases (M1-Status)
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)
tumor-specific prior chemo- or radiotherapy
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]
Life expectancy
Karnofsky performance status <70%
serious cardiopulmonary concomitant disease (cardiac insufficiency grade III and IV according NYHA status, myocardial infarction, angina pectoris, respiratory global insufficiency)
Chronic diseases with permanent-therapy (uncontrolled diabetes, active rheumatoid arthritis)
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
Other circumstances (contra-indications), which disallow treatment with Docetaxel, Cisplatin, 5-FU, Cetuximab or radiotherapy
Expected absent patient compliance
Periodic follow-up not possible (for example address outside germany)
Pregnant or breast-feeding woman
Absent or constricted legal capacity
Participation to another clinical trial with any investigational study within 30 days prior to study screening