Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel (DoIT_Neck)

University of Erlangen-Nürnberg Medical School

Status: Not yet enrolling

Conditions: Larynx Squamous Cell Carcinoma; Squamous Cell Carcinoma of Oropharynx; Squamous Cell Carcinoma of the Hypopharynx; Oral Cavity Squamous Cell Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT06947668

DoIT_Neck

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

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.