NCT06947668 Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel
| NCT ID | NCT06947668 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Erlangen-Nürnberg Medical School |
| Condition | Squamous Cell Carcinoma of Oropharynx |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2030-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2025-05-01 with a primary completion date of 2030-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Marlen Haderlein, MD
PRINCIPAL INVESTIGATOR
Universitätsklinikum Erlangen, Strahlenklinik
Frequently Asked Questions
Who can join the NCT06947668 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Squamous Cell Carcinoma of Oropharynx. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06947668 currently recruiting?
Yes, NCT06947668 is actively recruiting participants. Contact the research team at marlen.haderlein@uk-erlangen.de for enrollment information.
Where is the NCT06947668 trial being conducted?
This trial is being conducted at Erlangen, Germany.
Who is sponsoring the NCT06947668 clinical trial?
NCT06947668 is sponsored by University of Erlangen-Nürnberg Medical School. The principal investigator is Marlen Haderlein, MD at Universitätsklinikum Erlangen, Strahlenklinik. The trial plans to enroll 250 participants.