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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Radiation: Radiochemotherapy

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Jonas Werner, MD; Phone Number: 0041442059455; Email: jonas.werner@luks.ch
• Study Contact Backup: Name: Gunesh Rajan, MD; Phone Number: 0041442059455; Email: gunesh.rajan@luks.ch

Study Locations

• Switzerland
  • Lucerne, Switzerland
    • Recruiting
    • Department of Otorhinolaryngology - Head and Neck Surgery, Cantonal Hospital Lucerne
    • Contact: Jonas Werner, MD; Phone Number: 0041442057506; Email: jonas.werner@luks.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients undergoing primary radio(chemo)therapy for oral, oropharyngeal, epipharyngeal, hypopharyngeal or laryngeal squamous cell carcinoma at Cantonal Hospital Lucerne, Switzerland

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Overall survival, disease-specific survival, local and regional recurrence-free survival, and distant metastasis-free 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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Analysis	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.	At diagnosis

Collaborators and Investigators

• Sponsor: Luzerner Kantonsspital
• Collaborators: Universität Luzern

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 30, 2021
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: 2020-00317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No