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

NCT ID: NCT06947668

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2030-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marlen Haderlein, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Erlangen, Strahlenklinik

Locations

Universitätsklinikum Erlangen, Strahlenklinik

Erlangen, Bavaria, Germany

Countries

Germany

Central Contacts

Marlen Haderlein, MD

Role: CONTACT

marlen.haderlein@uk-erlangen.de

+49913185 ext. 33968

Charlotte Schmitter, MD

Role: CONTACT

charlotte.schmitter@uk-erlangen.de

+49913185 ext. 33968

Facility Contacts

Studiensekretariat

Role: primary

studiensekretariat.ST@uk-erlangen.de

+49913185 ext. 33968

Benjamin Frey, MD

Role: backup

benjamin.frey@uk-erlangen.de

+49913185 ext. 44248

Other Identifiers

DoIT_Neck

Identifier Type: -

Identifier Source: org_study_id