InductionChemo-Radio-Antibody-Treatment (ICRAT)

This is an interventional treatment trial for Squamous Cell Carcinoma of the Head focused on measuring induction chemotherapy, radiotherapy, locally advanced head neck tumor, toxicity, LA SCCHN, Unresectable squamous cell cancer of the head and neck,, Stage IV (UICC) Read More

Inclusion Criteria:

• Histologically proven unresectable SCC of the oral cavity, oropharynx and hypopharynx (stage IVA & IVB)
• 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 < 1 time the UNL of the participating center
• ASAT (SGOT) and ALAT (SGPT) < 2.5 x UNL
• Alkaline phosphatase < 5 x UNL

Renal function :

• serum creatinine (SC) < 120 µmol/L (1.4 mg/dl);
• if values are > 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.

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. arteriosclerosis with apoplexy, recent myocardial infarction, high-grade carotid stenoses, unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4, insulin-dependent diabetes mellitus, uncontrolled hypertension, liver cirrhosis (Quick < 75%, total protein <3.0 g/dl, bilirubin >2mg/ml) or kidney insufficiency (creatinine >1.4 mg/ml, the creatinine clearance should be > 60 ml/min)
• patients with ASAT or ALAT > 2.5 UNL associated with alkaline phosphatase > 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
• Prior accommodation in an institution under officially or judicially orders (§ 40 1 p. 3 No. 4 AMG)
• 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