Clinical trial NCT06947668: Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel
Official title: Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Squamous Cell Carcinoma of Oropharynx
Squamous Cell Carcinoma of the Hypopharynx
Larynx Squamous Cell Carcinoma
Oral Cavity Squamous Cell Carcinoma
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with squamous cell carcinoma of the head and neck without distant metastases, for whom definitive or postoperative chemoradiation is indicated and who are unfit for cisplatin.

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

Primary outcomes:
measure: Determining the feasibility of simultaneous chemoradiotherapy with docetaxel in cisplatin-ineligible patients based on immunophenotype
timeFrame: 61 months (duration of entire trial)
Secondary outcomes:
measure: Correlation of immunophenotype with overall survival, locoregional control and side effects
timeFrame: 61 months (duration of entire trial)
measure: Identification of immunological parameters associated with relevant treatment-related complications (e.g. infection, cytopenia)
timeFrame: 61 months (duration of entire trial)
measure: Identification of patients who will benefit from immunotherapy.
timeFrame: 61 months (duration of entire trial)
Other outcomes:
measure: Identification of the point in time when immunotherapy should be used
timeFrame: 61 months (duration of entire trial)
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Strahlenklinik
state: Bavaria
Study officials:
affiliation: Universitätsklinikum Erlangen, Strahlenklinik
name: Marlen Haderlein, MD
role: PRINCIPAL_INVESTIGATOR
References: