Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel

Inclusion criteria

• Patients with squamous cell carcinomas of the oropharynx, larynx and oral cavity for whom definitive or postoperative chemoradiation is indicated
• Patients who are cisplatin-unfit for chemotherapy, defined as:

• ECOG 2
• Organ dysfunction ≥ 2 according to National Cancer Institute Common Toxicity Criteria (NCI CTC) Version 4.0, such as hearing loss or tinnitus or neurological diseases
• Calculated creatinine clearance of ≤50ml/min
• Impaired organ function or comorbidities that preclude the use of cisplatin, e.g.: left ventricular ejection fraction < 50%, uncorrectable renal insufficiency with elevated creatinine despite creatinine clearance of 50ml/min due to increased body weight, uncontrolled hypertension
• Poor nutritional status BMI < 16kg/m²
• Concomitant use of nephrotoxic drugs that cannot be discontinued or converted due to other illnesses.
• Willingness of patients to provide blood, saliva and stool samples and consent to the preservation of all samples for study purposes
• Age ≥ 18 years
• Sufficient cognitive abilities of the patients to understand the purpose of the study and to consent to it

Exclusion criteria

• Distant metastases at the time of diagnosis and simultaneous second cancers, i.e. at the time of study inclusion
• Malignancies in the last 5 years regardless of location (except basal cell carcinoma or cervical uteri)
• Carcinomas in which no sample collection is possible or likely without compromising the pathological assessment
• Persistent drug or medication abuse
• Patients who are unwilling or unable to comply with the protocol and receive treatment
• Patients who are unsuitable for participation in the study due to a language barrier