NCT06947668Recruiting
Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 20 Apr 2025
- Start date
- 1 May 2025
- Primary completion date
- 1 Jun 2030
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Diseases
- Head and neck cancer
- NCT number
- NCT06947668
What you commit to
- Study type: Observational
- Planned participants: 250
- From 1 May 2025 to the primary completion date, 1 Jun 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Persistent drug or medication abuse
Other illness
- 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)
Other
- Carcinomas in which no sample collection is possible or likely without compromising the pathological assessment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinikum Erlangen, Strahlenklinik Coordinator of this site? Confirm its status | Erlangen | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.