Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

NCT05337631 · tracked via the Priya Life Science Germany tracker

Sponsor

University Hospital Freiburg

Phase

Observational

Started

2021-06-01

Last updated

2025-03-25

Condition(s) studied

HNSCCOral Cavity CancerOropharynx CancerHypopharynx CancerLarynx Cancer

Study summary

The number of elderly head-and-neck squamous cell carcinoma (HNSCC) patients is increasing; however, the evidence regarding the ideal treatment for this often vulnerable and frail patient cohort is limited. Although the benefit of concomitant chemotherapy has been reported to decrease in elderly HNSCC patients based on the MACH-NC meta-analysis, it remains unknown whether state-of-the art radiotherapy techniques such as intensity-modulated radiotherapy (IMRT), modern supportive treatments and alternative chemotherapy fractionation (e.g., cisplatin weekly) may have altered this observation. The objective of this retrospective multinational multicenter study is to determine the oncological outcomes of elderly patients (≥65 years) with locally advanced HNSCCs undergoing definitive (chemo-)radiation and to investigate the influence of concomitant chemotherapy on overall survival and progression-free survival after adjusting for potential confounder variables such as age, performance status and comorbidity burden.

Eligibility

Sex

ALL

Min age

65 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * definitive (chemo-)radiotherapy of locoregionally advanced (cT3-4 and/or cN+) head-and-neck squamous cell carcinomas (HNSCC) of the oral cavity, oropharynx, hypopharynx or larynx * primary treatment since 2005 * age ≥65 years at the time of (chemo-)radiotherapy Exclusion Criteria: * adjuvant (chemo-)radiotherapy * history of previous head-and-neck cancers or radiotherapy in the head-and-neck region * distant metastases at (chemo-)radiotherapy initiation (cM1) * HNSCCs of the nasopharynx, salivary glands, skin or with unknown primary

Primary outcome measure(s)

Overall survival (OS) — Up to 5 years
Time from radiotherapy start until death from any cause

Trial sites (18)

Facility	City	Region	Status
Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine	Baltimore	Maryland	Completed
Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai	New York	New York	Completed
Department of Radiation Oncology, Case Western Reserve University	Cleveland	Ohio	Completed
Division of Radiation Oncology, The Ohio State University Wexner	Columbus	Ohio	Completed
Radiation Oncology Department, German Oncology Center	Limassol	Cyprus	Completed
Brno University Hospital	Brno	Czechia	Completed
Department of Radiooncology and Radiotherapy, Charité-Universitätsmedizin Berlin	Berlin	Germany	Completed
Department of Radiation Oncology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg	Erlangen	Germany	Completed
Department of Radiotherapy and Oncology, Goethe-University Frankfurt am Main	Frankfurt	Germany	Completed
University of Giessen	Giessen	Germany	Completed
Martin-Luther-Universität Halle-Wittenberg	Halle	Germany	Completed
Jena University Hospital	Jena	Germany	Recruiting
Department of Radiation Oncology, University Hospital Schleswig-Holstein	Kiel	Germany	Completed
Department of Radiation Oncology, University Medical Center Leipzig	Leipzig	Germany	Completed
Department of Radiation Oncology, University Medical Center Mainz	Mainz	Germany	Completed
Department of Radiation Oncology, University Hospital, LMU Munich	Munich	Germany	Completed
Department of Radiation Oncology, University Hospital Würzburg	Würzburg	Germany	Completed
Department of Radiation Oncology, University Hospital Zurich (USZ), University of Zurich (UZH)	Zurich	Switzerland	Completed

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05337631 on ClinicalTrials.gov ↗ ← All trials in Germany