Clinical trial · Observational
Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel
NCT06947668CI-TRIAL-00120110DoIT_NeckrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Larynx Squamous Cell Carcinoma | Laryngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
| Oral Cavity Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Carcinoma of Oropharynx | Oropharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of the Hypopharynx | Hypopharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Treatment group
- description
- 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.
Primary outcomes (1)
- 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 (3)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.