About this trial
Analysis of tumor tissue (which is already available in pathology) and collection of saliva/stool and blood samples, which are obtained as part of a routine collection. These will be evaluated together with the patients' clinical data to identify possible predictors for treatment feasibility, survival, tumor control and potentially increased tumor immunogenicity by docetaxel.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with squamous cell carcinomas of the oropharynx, larynx and oral cavity for whom definitive or postoperative chemoradiation is indicated
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
Disqualifiers
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
Trial population
Patients with squamous cell carcinoma of the head and neck without distant metastases, for whom definitive or postoperative chemoradiation is indicated and who are unfit for cisplatin.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Determining the feasibility of simultaneous chemoradiotherapy with docetaxel in cisplatin-ineligible patients based on immunophenotype
Secondary outcomes
Correlation of immunophenotype with overall survival, locoregional control and side effects
Identification of immunological parameters associated with relevant treatment-related complications (e.g. infection, cytopenia)
Identification of patients who will benefit from immunotherapy.
Other outcomes
Identification of the point in time when immunotherapy should be used
Sponsors and contacts
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