Patients with histologically proven unresectable squamous cell carcinoma of the oral cavity, oropharynx and hypopharynx (stage IVa & IVb).
Conditions
Interventions
Product Name: Cisplatin
Pharmaceutical Form: Solution for infusion
Trade Name: Docetaxel, Taxotere
Product Name: Docetaxel
Product Code: XRP6976
Pharmaceutical Form: Solution for infusion
Trade Name
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically proven unresectable SCC of the oral cavity, oropharynx and hypopharynx (stage IVa & IVa) Written and signed informed consent Karnofsky PS > 70 % Age = 18 years Curative treatment intent Adequate bone marrow, hepatic and renal functions as evidenced by the following: Hematology (Bone marrow): Neutrophils > 2.0 109/L Platelets > 100 x 109/L Hemoglobin > 10 g/dL Hepatic function Total serum bilirubin 120 µmol/L, the creatinine clearance should be > 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows : weight (kg) x (140 - age) --------------------------------- K x serum creatinine serum creatinine in mg/dL: K = 72 in man K = 85 in woman serum creatinine in µmol/L: K = 0.814 in man K = 0.96 in woman If of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing. All patients require: dental examination and appropriate dental preservation if needed 1 week prior to the beginning of radiotherapy, gastric feeding tube and Portal-catheter. 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: Other neoplasia within the past 5 years with the exception of a controlled skin cancer or “in situ” cervix cancer Unknown primary (CUP), nasopharynx, laryngeal or salivary gland cancer Distant metastatic disease (M1) Serious co-morbidity, e.g. arterosclerosis with apoplexy, recent myocardial infarction, high-grade carotic stenoses, unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4, Insulin-dependent diabetes mellitus, uncontrolled hypertension, liver szirrhosis (Quick 2mg/ml) or kidney insufficiency (creatinine >1.4 mg/ml, the creatinine clearance should be > 60 ml/min) patients with ASAT or ALAT > 1.5 UNL associated with alkaline phosphatase > 2.5 UNL are not eligible for the study Known HIV-infection Pregnancy or lactation Women of child-bearing potential with unclear contraception Previous treatment of the disease with chemotherapy, radiotherapy, EGFR-targeting agents or surgery exceeding biopsy in head and neck Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening Social situations that limit compliance with study requirements Deficient dental preservation status or not accomplished wound healing Legal incapacity Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grade 2 and/or ototoxicity grade 2, except if due to trauma or mechanical impairment due to tumor mass Known allergic/hypersensitivity reaction to any of the components of the treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Feasibility of an experimental fractionated TPF regimen vs. a standard TPF induction chemotherapy protocol followed by a standard radio-antibodytherapy vs. standard chemoradiation as control. A composite endpoint driven by compliance resulting from on time application of radio-antibodytherapy as well as acute hematological toxicity of the experimental TPF regime and equal efficacy by response rates is used. ;Secondary Objective: All adequate items illustrating acute toxicity and late morbidity, in particular by hematological and neurological measures until one year after treatment (according to CTCAE v.4.02) treatment intensity achieved Survival (progression-free, metastases-free, recurrence-free, Overall) after 1 year Response rates after TPF-Induction CHT (RECIST) Response rates after completion of multimodal treatment (RECIST) Efficacy in relation to HPV status (p16 IHC) circulating tumor cells Quality of life according to EORTC QLC-30 & HN35 ;Primary end point(s): Composite endpoint of compliance and efficacy in terms of response (RECIST) and hematological acute toxicity (CTCAE v.4.02) on time application of radio-antibodytherapy following an experimental or standard TPF induction chemotherapy | — |
Countries
Germany
Outcome results
None listed