Immune biomarker testing in cisplatin-ineligible head and neck squamous cell cancer patients treated with chemoradiation and docetaxel

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study analyzes tumor tissue already stored in pathology and collects blood, saliva and stool samples taken during routine care from cisplatin-ineligible patients with squamous cell carcinomas of the oropharynx, hypopharynx, larynx or oral cavity who receive chemoradiation with docetaxel. Laboratory assays will profile immune-related biomarkers in these samples and correlate findings with clinical data on treatment feasibility, tumor control and survival. The study will also look for signs that docetaxel increases tumor immunogenicity. No experimental therapies are given; participation involves sample use and linkage to clinical records.

Why it matters

Who can join: the full rules

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

Where it's running

• Universitätsklinikum Erlangen, Strahlenklinik
  Erlangen, Bavaria, Germany Recruiting

Study contacts

• Principal investigator: Marlen Haderlein, MD — Universitätsklinikum Erlangen, Strahlenklinik
• Study coordinator: Marlen Haderlein, MD
• Email: marlen.haderlein@uk-erlangen.de
• Phone: +49913185

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.