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Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel | Clinical Trials | Clareo Health

RECRUITING

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

NCT06947668•University of Erlangen-Nürnberg Medical School

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+1 more criteria

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

Locations (1)

Universitätsklinikum Erlangen, Strahlenklinik

Erlangen, Bavaria, Germany

Key Dates

Start Date

May 1, 2025

Primary Completion Date

June 1, 2030

Completion Date

December 31, 2030

Last Updated

March 12, 2026

Enrollment

250

ESTIMATED participants

Conditions

Squamous Cell Carcinoma of OropharynxSquamous Cell Carcinoma of the HypopharynxLarynx Squamous Cell CarcinomaOral Cavity Squamous Cell Carcinoma

Contacts

Marlen Haderlein, MD

CONTACT

+49913185 marlen.haderlein@uk-erlangen.de

Charlotte Schmitter, MD

CONTACT

+49913185 charlotte.schmitter@uk-erlangen.de

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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