Head and Neck Squamous Cell Carcinoma
Conditions
Brief summary
The aim of the study is to prospectively evaluate whether markers of a patient's systemic inflammatory response in addition to FDG-PET/CT metabolic parameters of the primary tumor or of nodal metastases can predict radioresistance and survival before primary radiochemotherapy in advanced head and neck cancer patients.
Detailed description
This study prospectively investigates pretherapeutic markers of systemic inflammatory response (including neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, lymphocyte-to-monocyte ratio, systemic inflammation response index, and systemic immune-inflammation) and FDG-PET/CT-derived metabolic parameters of tumor and nodal metastases (including maximum standardized uptake value, metabolic tumor volume, and total lesion glycolysis) and their potential prognostic value in head and neck cancer patients prior to primary radiochemotherapy.
Interventions
RADIATIONRadiochemotherapy
Primary radiotherapy of the primary tumor and nodal basin with curative intent with or without concomitant chemotherapy with cisplatin, carboplatin, or cetuximab weekly.
Sponsors
Universität Luzern
Luzerner Kantonsspital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* histopathologic diagnosis of squamous cell carcinoma of the head and neck * primary radio(chemo)therapy with curative intent * available pretherapeutic FDG-PET/CT imaging * available pretherapeutic differential blood analysis
Exclusion criteria
* other tumor entities of the head and neck including cutaneous squamous cell carcinoma * primary surgical treatment * ongoing infections or other inflammatory diseases at the time of diagnosis * patients not completing a course of irradiation with at least 66 Gray locally
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | Prospective analysis of various measures of survival up to 5 years after completion of the therapy. Events such as tumor recurrence or death will be recorded continually. | Overall survival, disease-specific survival, local and regional recurrence-free survival, and distant metastasis-free survival |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation Analysis | At diagnosis | Analysis of a correlation of pretherapeutic systemic inflammatory markers in differential blood analysis including neutrophil-to-lympocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lym-phocyte-to-monocyte ratio (LMR), systemic immune-inflammation index (SII), and systemic in-flammation response index (SIRI) and FDG-PET/CT-derived parameters of tumor metabolism such as maximum standardized uptake value (SUVmax), total lesion glycolysis (TLG), and metabolic tumor volume (MTV) of the primary tumor and lymph node metastases. |
Countries
Switzerland
Contacts
Primary ContactJonas Werner, MD
Backup ContactGunesh Rajan, MD
Outcome results
None listed