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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05217212
• Other study ID #: 2020-00317
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Luzerner Kantonsspital
• Contact: Jonas Werner, MD
• Phone: 0041442059455
• Email: jonas.werner[@]luks.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Radiation:
• Radiochemotherapy
Primary radiotherapy of the primary tumor and nodal basin with curative intent with or without concomitant chemotherapy with cisplatin, carboplatin, or cetuximab weekly.

Locations

Country	Name	City	State
Switzerland	Department of Otorhinolaryngology - Head and Neck Surgery, Cantonal Hospital Lucerne	Lucerne

Sponsors (2)

Lead Sponsor	Collaborator
Luzerner Kantonsspital	Universität Luzern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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.