TPF Followed by Cetuximab and IMRT Plus Carbon Ion Boost for Locally Advanced Head and Neck Tumors (TPF-C-HIT)

This is an interventional treatment trial for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN): Oro-, Hypopharyngeal and Laryngeal Cancer focused on measuring SCCHN, squamous cell carcinoma of the head and neck, oropharyngeal carcinoma, hypopharyngeal carcinoma, laryngeal carcinoma Read More

Inclusion Criteria:

• Signed written informed consent,
• Age of 18 to 70 years,
• Life expectancy of at least 6 month,
• Ability of subject to understand character and individual consequences of clinical trial,
• Histologically confirmed locally advanced (stage III or IV), non-metastatic squamous cell carcinoma of oro-, hypopharynx and larynx (T2-4, any N, M0),
• Oral cavity or oro- , hypopharynx or laynx as the primary tumor site,
• At least one uni-measurable lesion according to the RECIST criteria, Karnofsky Performances Status > 70%,
• Adequate bone marrow function: neutrophils > 1.5 x 109/L, platelets > 100 x 109/L, hemoglobin > 10.0 g/dL,
• Adequate liver function: Bilirubin < 1.5 mg/dL, SGOT, SGPT < 3 x ULN, GGT < 5 x ULN,
• Adequate renal function: GFR> 70 ml/min,
• Negative serum/urine Beta-HCG test in women of childbearing potential,
• Women of childbearing potential: willingness to use effective contraceptive method, defined as the concomitant use of either an intrauterine pessary (IUP) or contraceptive pill and in both cases, condoms for the treatment duration and 2 months thereafter. Women of non-childbearing potiential are those who are post-menopausal for at least 1 year or sterilized,
• Men of procreative potential: willingness for effective prevention of procreation, defined as a use of condoms and a use of either an intrauterine pessary (IUP) or a contraceptive pill by his partner for the treatment duration and 2 months thereafter,
• Subject's consent to collect blood and/or tumor tissue samples for proteomics and genomics. If a patient does not consent, no samples for proteomics and genomics will be taken. Nonetheles, he/she may be enroled in the study

Exclusion Criteria:

• Previous systemic chemotherapy, radiotherapy or surgery for carcinoma of the head, neck and larynx,
• Nasopharyngeal Carcinoma,
• Prior exposure to EGFR pathway targeting therapy,
• Evidence of distant metastases.
• Other serious illness or medical conditions:
• Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4,
• Significant neurologic or psychiatric disorders including dementia or seizures,
• Active disseminated intravascular coagulation,
• Other serious underlying medical conditions which in the opinion of investigator could impair the ability of the patient to participate in the study,
• Symptomatic peripheral neuropathy Common Toxicity Criteria (CTC) grade 2 or higher,
• ototoxicity CTC grade 2 or higher, except if due to trauma or mechanical impairment due to tumor mass,
• Participation in other interventional trial within the last 30 days§§,
• Surgery within the last 30 days,
• Known allergic/hypersensitivity reaction to any drugs scheduled for the study treatment,
• Women: pregnant or breast-feeding,
• Known drug abuse,
• Other previous malignancy within 5 years, with exception of a history of a previous, adequately treated, basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix,
• Legal incapacity or limited legal capacity,
• Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.