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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Head and Neck Squamous Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Radiochemotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No