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

NCT06947668 | Recruiting

• 1 other identifier: DoIT_Neck
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Determining the feasibility of simultaneous chemoradiotherapy with docetaxel in cisplatin-ineligible patients based on immunophenotype

  61 months (duration of entire trial)

Secondary Outcomes (3)

• Correlation of immunophenotype with overall survival, locoregional control and side effects

  61 months (duration of entire trial)

• Identification of immunological parameters associated with relevant treatment-related complications (e.g. infection, cytopenia)

  61 months (duration of entire trial)

• Identification of patients who will benefit from immunotherapy.

  61 months (duration of entire trial)

Other Outcomes (1)

• Identification of the point in time when immunotherapy should be used

  61 months (duration of entire trial)

Study Arms (1)

Treatment group

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Universitätsklinikum Erlangen, Strahlenklinik

Erlangen, Bavaria, 91054, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tumour tissue; stool sample; blood samples; saliva samples (mucosal swabs)

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Marlen Haderlein, MD

  Universitätsklinikum Erlangen, Strahlenklinik

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlen Haderlein, MD

CONTACT

+49913185; marlen.haderlein@uk-erlangen.de

Charlotte Schmitter, MD

CONTACT

+49913185; charlotte.schmitter@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: April 27, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 12, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)