Do Markers of Systemic Inflammatory Response and Tumor Metabolism Indicate Radioresistance in Head and Neck Cancer?
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
December 30, 2021
CompletedFirst Posted
Study publicly available on registry
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedOctober 10, 2023
October 1, 2023
4.9 years
December 30, 2021
October 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Correlation Analysis
At diagnosis
Interventions
Primary radiotherapy of the primary tumor and nodal basin with curative intent with or without concomitant chemotherapy with cisplatin, carboplatin, or cetuximab weekly.
Eligibility Criteria
All patients undergoing primary radio(chemo)therapy for oral, oropharyngeal, epipharyngeal, hypopharyngeal or laryngeal squamous cell carcinoma at Cantonal Hospital Lucerne, Switzerland
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Luzerner Kantonsspitallead
- Universität Luzerncollaborator
Study Sites (1)
Department of Otorhinolaryngology - Head and Neck Surgery, Cantonal Hospital Lucerne
Lucerne, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2021
First Posted
February 1, 2022
Study Start
January 1, 2020
Primary Completion
December 1, 2024
Study Completion
December 1, 2025
Last Updated
October 10, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share