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

Launched by UNIVERSITY OF ERLANGEN-NÜRNBERG MEDICAL SCHOOL · Apr 25, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating how certain immune markers in patients with specific types of throat and mouth cancers may help predict how well they will respond to treatment. The study focuses on patients who cannot receive a common chemotherapy drug called cisplatin due to other health issues. Researchers will collect samples of blood, saliva, and stool, along with existing tumor tissue, to analyze these alongside the patients' medical histories. The goal is to find out what factors might indicate better outcomes, such as improved survival rates and tumor control when treated with chemoradiotherapy and another drug called docetaxel.

To be eligible for the trial, participants must be adults aged 18 and older with squamous cell carcinoma of the oropharynx, larynx, or oral cavity who need chemoradiation but are unable to take cisplatin due to health concerns like organ dysfunction or other serious conditions. Participants should be willing to provide the necessary samples and understand the purpose of the study. It's important to note that this trial has not started recruiting participants yet, so individuals interested in joining will need to wait for further announcements.

Gender

ALL

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