Squamous Cell Carcinoma of OropharynxDoIT_NeckNCT06947668
Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel
An observational study of Squamous Cell Carcinoma of Oropharynx and Squamous Cell Carcinoma of the Hypopharynx, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of the Hypopharynx, Larynx Squamous Cell Carcinoma
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2025to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Erlangen, Strahlenklinik
Erlangen, Bavaria, 91054
Studiensekretariat, +49913185 ext. 33968, studiensekretariat.ST@uk-erlangen.de
Benjamin Frey, MD, +49913185 ext. 44248, benjamin.frey@uk-erlangen.de
About this study
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
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the feasibility of simultaneous chemoradiotherapy with docetaxel in cisplatin-ineligible patients based on immunophenotype
Measured: 61 months (duration of entire trial)
Secondary outcomes (3)
Correlation of immunophenotype with overall survival, locoregional control and side effects
Measured: 61 months (duration of entire trial)
Identification of immunological parameters associated with relevant treatment-related complications (e.g. infection, cytopenia)
Measured: 61 months (duration of entire trial)
Identification of patients who will benefit from immunotherapy.
Measured: 61 months (duration of entire trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 May 2025
- Primary completion1 Jun 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of OropharynxStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlen Haderlein, MD, Principal investigator, Universitätsklinikum Erlangen, Strahlenklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947668
- Sponsor's protocol ID
- DoIT_Neck
- Acronym
- DoIT_Neck
- Status last verified
- Jul 2026
- First submitted
- 20 Apr 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel
- ClinicalTrials.gov ID
- NCT06947668
- Acronym / sponsor ID
- DoIT_Neck / DoIT_Neck
- Conditions
- Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of the Hypopharynx, Larynx Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determining the feasibility of simultaneous chemoradiotherapy with docetaxel in cisplatin-ineligible patients based on immunophenotype
Time frame: 61 months (duration of entire trial)
3 secondary outcomes
Correlation of immunophenotype with overall survival, locoregional control and side effects
Time frame: 61 months (duration of entire trial)
Identification of immunological parameters associated with relevant treatment-related complications (e.g. infection, cytopenia)
Time frame: 61 months (duration of entire trial)
Identification of patients who will benefit from immunotherapy.
Time frame: 61 months (duration of entire trial)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marlen Haderlein, MD principal investigator
Universitätsklinikum Erlangen, Strahlenklinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma of Oropharynx and Squamous Cell Carcinoma of the Hypopharynx, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marlen Haderlein, MD (+49913185 ext. 33968, marlen.haderlein@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining the feasibility of simultaneous chemoradiotherapy with docetaxel in cisplatin-ineligible patients based on immunophenotype (time frame: 61 months (duration of entire trial)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.