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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Erlangen-Nürnberg Medical School

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with squamous cell carcinomas of the oropharynx, larynx and oral cavity for whom definitive or postoperative chemoradiation is indicated

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

250 Participants
are grouped into 1 trial group
Group A: Treatment group

Trial outcomes

Primary outcomes

1

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

Time frame
61 months (duration of entire trial)

Secondary outcomes

1

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

Time frame
61 months (duration of entire trial)
2

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

Time frame
61 months (duration of entire trial)
3

Identification of patients who will benefit from immunotherapy.

Time frame
61 months (duration of entire trial)

Other outcomes

1

Identification of the point in time when immunotherapy should be used

Time frame
61 months (duration of entire trial)

Sponsors and contacts

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