Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-24 @ 6:27 PM
NCT ID:
NCT06947668
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06947668
Study Brief:
Protocol Section:
NCT06947668