Actively Recruiting
Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel
Led by University of Erlangen-Nürnberg Medical School · Updated on 2026-03-12
250
Participants Needed
1
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with squamous cell carcinomas of the oropharynx, larynx, and oral cavity who need definitive or postoperative chemoradiation
- Patients who are unfit for cisplatin chemotherapy, defined by at least one of the following: ECOG 2; organ dysfunction grade 2 or higher per NCI CTC v4.0 such as hearing loss, tinnitus, or neurological disease; creatinine clearance 50 ml/min or less; impaired organ function or comorbidities precluding cisplatin use (e.g., left ventricular ejection fraction below 50%, uncorrectable renal insufficiency despite creatinine clearance of 50 ml/min, uncontrolled hypertension); poor nutritional status with BMI below 16 kg/m²; use of nephrotoxic drugs that cannot be stopped or switched
- Willingness to provide blood, saliva, and stool samples and consent to sample preservation for research
- Age 18 years or older
- Sufficient cognitive ability to understand and consent to the study
You will not qualify if you...
- Having distant metastases or a second cancer at the time of diagnosis or study enrollment
- History of malignancy within the last 5 years, except for basal cell carcinoma or cervical uterine cancer
- Tumors where sample collection is not possible or would compromise pathological assessment
- Persistent drug or medication abuse
- Unwillingness or inability to comply with the study protocol and treatment
- Unsuitability for participation due to language barriers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Universitätsklinikum Erlangen, Strahlenklinik
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
Research Team
M
Marlen Haderlein, MD
CONTACT
C
Charlotte Schmitter, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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