Can immune markers predict success of docetaxel chemoradiotherapy?
NCT ID NCT06947668
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This study looks at immune markers in tumor tissue, saliva, stool, and blood from 250 head and neck cancer patients who cannot receive cisplatin chemotherapy. Researchers want to see if these markers can predict how well patients respond to chemoradiotherapy with docetaxel. The goal is to find better ways to personalize treatment for this group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- docetaxel
- What this could lead to
- If successful, this could help doctors identify which patients are most likely to benefit from docetaxel-based chemoradiotherapy, improving treatment choices.
- What could go wrong
- This is an observational biomarker study, not a treatment trial. It may not lead to direct improvements in care, and results might not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Universitätsklinikum Erlangen, Strahlenklinik
RECRUITINGErlangen, Bavaria, 91054, Germany
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- Aiming to spare the neck: could smarter radiation cut side effects in oral cancer?