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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Marlen Haderlein, MD; Phone Number: 33968 +49913185; Email: marlen.haderlein@uk-erlangen.de
• Study Contact Backup: Name: Charlotte Schmitter, MD; Phone Number: 33968 +49913185; Email: charlotte.schmitter@uk-erlangen.de

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Universitätsklinikum Erlangen, Strahlenklinik
      • Contact: Studiensekretariat; Phone Number: 33968 +49913185; Email: studiensekretariat.ST@uk-erlangen.de
      • Contact: Benjamin Frey, MD; Phone Number: 44248 +49913185; Email: benjamin.frey@uk-erlangen.de
      • Principal Investigator: Marlen Haderlein, MD
      • Sub-Investigator: Charlotte Schmitter, MD
      • Sub-Investigator: Phillip Schubert, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determining the feasibility of simultaneous chemoradiotherapy with docetaxel in cisplatin-ineligible patients based on immunophenotype	61 months (duration of entire trial)

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Identification of the point in time when immunotherapy should be used	61 months (duration of entire trial)

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: Principal Investigator: Marlen Haderlein, MD, Universitätsklinikum Erlangen, Strahlenklinik

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: April 20, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: DoIT_Neck

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No