Recruiting NCT06947668
Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of the Hypopharynx, Larynx Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Determining the feasibility of simultaneous chemoradiotherapy with docetaxel in cisplatin-ineligible patients based on immunophenotype [Time frame: 61 months (duration of entire trial)]
Secondary outcome measures (3)
- Correlation of immunophenotype with overall survival, locoregional control and side effects [Time frame: 61 months (duration of entire trial)]
- Identification of immunological parameters associated with relevant treatment-related complications (e.g. infection, cytopenia) [Time frame: 61 months (duration of entire trial)]
- Identification of patients who will benefit from immunotherapy. [Time frame: 61 months (duration of entire trial)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Universitätsklinikum Erlangen, Strahlenklinik — Erlangen
Identifiers
NCT: NCT06947668 · DoIT_Neck