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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Determining the feasibility of simultaneous chemoradiotherapy with docetaxel in cisplatin-ineligible patients based on immunophenotype | 61 months (duration of entire trial) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of immunophenotype with overall survival, locoregional control and side effects | 61 months (duration of entire trial) | |
| Identification of immunological parameters associated with relevant treatment-related complications (e.g. infection, cytopenia) |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of the point in time when immunotherapy should be used | 61 months (duration of entire trial) |
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:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marlen Haderlein, MD | Contact | +49913185 | 33968 | marlen.haderlein@uk-erlangen.de |
| Charlotte Schmitter, MD | Contact | +49913185 | 33968 | charlotte.schmitter@uk-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Marlen Haderlein, MD | Universitätsklinikum Erlangen, Strahlenklinik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Erlangen, Strahlenklinik | Recruiting | Erlangen | Bavaria | 91054 | Germany |
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tumour tissue; stool sample; blood samples; saliva samples (mucosal swabs)
| 61 months (duration of entire trial) |
| Identification of patients who will benefit from immunotherapy. | 61 months (duration of entire trial) |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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