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

Recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma

• Registration Number: NCT05217212
• Lead Sponsor: Luzerner Kantonsspital

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-12-30
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-02-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-10
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Otorhinolaryngology - Head and Neck Surgery, Cantonal Hospital Lucerne; 🇨🇭 Lucerne, Switzerland