Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel
Recruiting
Observational Study
Squamous Cell Carcinoma of OropharynxSquamous Cell Carcinoma of the HypopharynxLarynx Squamous Cell CarcinomaOral Cavity Squamous Cell Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
250 (estimated)
Sponsor
University of Erlangen-Nürnberg Medical School · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.