RecruitingNCT06947668
Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel
Sponsor
University of Erlangen-Nürnberg Medical School
Enrollment
250 participants
Start Date
May 1, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
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
Min Age: 18 Years
Inclusion Criteria11
- 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 Criteria6
- 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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06947668
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