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

Rekrutierend

NCT-Nummer:
NCT05217212

Studienbeginn:
Januar 2020

Letztes Update:
10.10.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Luzerner Kantonsspital

Collaborator:
Universität Luzern

Kontakt

Jonas Werner, MD
Kontakt:
Phone: 0041442059455
E-Mail: jonas.werner@luks.ch» Kontaktdaten anzeigen

Gunesh Rajan, MD
Kontakt:
Phone: 0041442059455
E-Mail: gunesh.rajan@luks.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Otorhinolaryngology - Head and Neck Surgery, Cantonal Hospital Lucerne
Lucerne
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Jonas Werner, MD
Phone: 0041442057506
E-Mail: jonas.werner@luks.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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

Geprüfte Regime

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

Quelle: ClinicalTrials.gov