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

Recruitingn/aAges 18 Years - anyAllUniversity of Erlangen-Nürnberg Medical School
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
Universitätsklinikum Erlangen, Strahlenklinik
Erlangen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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