by laryngectomy operable carcinoma of the larynx and the hypopharynx MedDRA version: 14.1 Level: LLT Classification code 10023906 Term: Larynx carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 10041849 Term: Squamous cell carcinoma of the hypopharynx System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Taxotere
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 148408-66-6
Other descriptive name: DOCETAXEL TRIHYDRATE
Concentration unit: mg milligram(s)
Concentration
Sponsors
Universität Leipzig
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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, postcricoidal) and hypopharynx segmental resection - N-status: cervical metastases (N0-N3) have to be rehabilitate by surgical procedures • Blood count: Leucocytes >3500/mm\3, Neutrophils > 1500/ mm\3, Thrombocytes > 8000/ mm\3 • Clinical chemistry: - adequate renal function, defined by serum creatinine and urea not higher than 25% upper NL, creatinine-clearance > 60 ml/min/1,72 m\2 - adequate hepatic function with SGOT, SGPT not higher than 50% and bilirubin not higher than upper NL - electrolytes at NL • 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 contracepition 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 implantat (luteal hormone containing rod), abstinence or sterilization (vasectomy) of the male) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 < 3 Monate • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Confirmatory proof of an adequate survival rate with a functionally larynx -conserving 2 years after randomisation;Secondary Objective: • Descriptive analysis of the study arms concerning the secondary end criteria of the trial • Explorative comparison of the study arms concerning the primary and secondary end criteria of the trial ;Primary end point(s): tumor reduktion of larynx/hypopharynx carcinoma < 30% = end of study tumor reduktion = 30% = 2 cycles of TP/TPF and Cetuximab than radiation. Premature ending in case of PD, not acceptable toxicitys, if patient wishes therapy abort, or exclusion of patient´s participation in study in opinion of the responsible physician | — |
Countries
Austria, Germany
Outcome results
None listed