Larynx Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of the Hypopharynx
Conditions
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.
Interventions
None listed
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determining the feasibility of simultaneous chemoradiotherapy with docetaxel in cisplatin-ineligible patients based on immunophenotype | 61 months (duration of entire trial) |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of immunophenotype with overall survival, locoregional control and side effects | 61 months (duration of entire trial) |
| Identification of immunological parameters associated with relevant treatment-related complications (e.g. infection, cytopenia) | 61 months (duration of entire trial) |
| Identification of patients who will benefit from immunotherapy. | 61 months (duration of entire trial) |
Countries
Germany
Contacts
CONTACTMarlen Haderlein, MD
CONTACTCharlotte Schmitter, MD
PRINCIPAL_INVESTIGATORMarlen Haderlein, MD
Universitätsklinikum Erlangen, Strahlenklinik
Outcome results
None listed