Status:
NOT_YET_RECRUITING
Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Squamous Cell Carcinoma of Oropharynx
Squamous Cell Carcinoma of the Hypopharynx
Eligibility:
All Genders
18+ years
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 togethe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06947668
Start Date
May 1 2025
End Date
December 31 2030
Last Update
April 27 2025
Active Locations (1)
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1
Universitätsklinikum Erlangen, Strahlenklinik
Erlangen, Bavaria, Germany, 91054