ClinicalTrials.gg
RecruitingNCT06947668DoIT_NeckUpdated Jul 31, 2026

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

An observational study in Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of the Hypopharynx and Larynx Squamous Cell Carcinoma, sponsored by University of Erlangen-Nürnberg Medical School. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by University of Erlangen-Nürnberg Medical School · Observational

From the registry’s dates

  • Started May 2025; still recruiting 1 year 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Squamous Cell Carcinoma of Oropharynx
  • Squamous Cell Carcinoma of the Hypopharynx
  • Larynx Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma
03

In context

Squamous Cell Carcinoma of Head and Neck

2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.

This study's planned enrollment of 250 is above the median of 100 across 236 observational studies indexed under Squamous Cell Carcinoma of Head and Neck.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Lead sponsor

University of Erlangen-Nürnberg Medical School is the lead sponsor of 276 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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:

    • 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 of ≤50ml/min
    • Impaired organ function or comorbidities that preclude the use of cisplatin, e.g.: \< 50%, uncorrectable renal insufficiency with elevated creatinine despite creatinine clearance of 50ml/min due to increased body weight, uncontrolled hypertension
    • Poor nutritional status \< 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

Exclusion Criteria:

  • Distant at the time of diagnosis and simultaneous second cancers, i.e. at the time of study inclusion
  • 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
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

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)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2025 (actual). Primary completion is estimated for Jun 2030, 61 months after the start.

Of 108 non-industry observational studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 132. This study's planned 61 months is below that.

Counting every sponsor, half of 118 studies reached it within 81 months; a quarter within 29 and three quarters within 132.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 20, 2025
First posted
Apr 27, 2025
StartActual
May 1, 2025
Primary completionEst.
Jun 1, 2030
CompletionEst.
Dec 31, 2030
Last update
Jul 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06947668
Responsible party
Sponsor
First posted
Apr 27, 2025
Start date
May 1, 2025
Primary completion
Jun 1, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Jul 31, 2026

Study contacts

Marlen Haderlein, MD
Contact
marlen.haderlein@uk-erlangen.de
+49913185 ext. 33968
Charlotte Schmitter, MD
Contact
charlotte.schmitter@uk-erlangen.de
+49913185 ext. 33968
Marlen Haderlein, MD
principal investigator · Universitätsklinikum Erlangen, Strahlenklinik

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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