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
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with squamous cell carcinoma of the head and neck who cannot receive cisplatin chemotherapy. The study focuses on evaluating tumor tissue and collecting saliva, stool, and blood samples to find markers that may predict treatment success, survival, tumor control, and the immune response to docetaxel chemotherapy combined with radiation. This observational study aims to better understand treatment options for patients unfit for cisplatin. Participants receive chemoradiotherapy with docetaxel instead of cisplatin. Tumor tissue already obtained in pathology is analyzed, and routine clinical samples are collected during treatment. The study tracks how well docetaxel chemoradiotherapy can be tolerated and its effects on immune markers, survival, tumor control, and side effects over the course of treatment. During the study, researchers will review participants' clinical data alongside immune and tumor analyses to identify predictors of treatment feasibility and outcomes. Samples such as blood, saliva, and stool are collected as part of routine care. The main measure is the feasibility of docetaxel chemoradiotherapy in these patients, with follow-up lasting up to 61 months. Safety and treatment-related complications are also monitored throughout this period.
CONDITIONS
Brief 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 carcinoma of the oropharynx, larynx, or oral cavity needing definitive or postoperative chemoradiation
- Patients who cannot receive cisplatin chemotherapy due to factors such as ECOG 2 status, organ dysfunction (e.g., hearing loss, neurological disease), low creatinine clearance (≤50 ml/min), impaired organ function or comorbidities, poor nutrition (BMI < 16 kg/m²), or use of nephrotoxic drugs that cannot be stopped
- Willingness to provide blood, saliva, and stool samples and consent to sample preservation
- Age 18 years or older
- Sufficient cognitive ability to understand and consent to the study
You will not qualify if you...
- Presence of distant metastases or a second cancer at the time of diagnosis or study entry
- Any cancer diagnosed within the last 5 years except basal cell carcinoma or cervical uterine cancer
- Tumors where sample collection is not possible without affecting pathology assessment
- Persistent drug or medication abuse
- Inability or unwillingness to follow study protocol and treatment
- Language barriers preventing study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 61 months
Participants receiving chemoradiotherapy with docetaxel are observed, and blood, saliva, and stool samples are collected to study immune biomarkers and treatment-related effects.
Visits scheduled according to treatment and sample collection needs
Trial Site Locations
Total: 1 location
1
Universitätsklinikum Erlangen, Strahlenklinik
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
Research Team
M
Marlen Haderlein, MD
C
Charlotte Schmitter, MD
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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