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Clinical Trials/NCT05217212
NCT05217212
Recruiting
Not Applicable

Do Markers of Systemic Inflammatory Response and Tumor Metabolism Indicate Radioresistance in Head and Neck Cancer?

Luzerner Kantonsspital1 site in 1 country100 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Head and Neck Squamous Cell Carcinoma
Sponsor
Luzerner Kantonsspital
Enrollment
100
Locations
1
Primary Endpoint
Survival
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
December 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Survival

Time Frame: 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

Study Sites (1)

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